What Is Pain? What Causes Pain?

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of MedicalNewsToday.com

Written by Christian Nordqvist

The English word ‘pain’ probably comes from Old French (peine), Latin (poena – meaning punishment pain), or Ancient Greek (poine – a word more related to penalty), or a combination of all three.

In medicine pain relates to a sensation that hurts. If you feel pain it hurts, you feel discomfort, distress and perhaps agony, depending on the severity of it. Pain can be steady and constant, in which case it may be an ache. It might be a throbbing pain – a pulsating pain. The pain could have a pinching sensation, or a stabbing one.

Only the person who is experiencing the pain can describe it properly. Pain is a very individual experience.

Types of pain

Acute pain – this can be intense and short-lived, in which case we call it acute pain. Acute pain may be an indication of an injury. When the injury heals the pain usually goes away.

Chronic pain – this sensation lasts much longer than acute pain. Chronic pain can be mild or intense (severe).

How do we classify pain?

Pain can be nociceptive, non-nociveptive, somatic, visceral, neuropathic, or sympathetic. Look at the details below.

Pain

Nociceptive: Somatic – Visceral: Non-Nociceptive: Neuropathic – Sympathetic

Nociceptive Pain – specific pain receptors are stimulated. These receptors sense temperature (hot/cold), vibration, stretch, and chemicals released from damaged cells.

Somatic Pain – a type of nociceptive pain. Pain felt on the skin, muscle, joints, bones and ligaments is called somatic pain. The term musculo-skeletal pain means somatic pain. The pain receptors are sensitive to temperature (hot/cold), vibration, and stretch (in the muscles). They are also sensitive to inflammation, as would happen if you cut yourself, sprain something that causes tissue damage. Pain as a result of lack of oxygen, as in ischemic muscle cramps, are a type of nociceptive pain. Somatic pain is generally sharp and well localized – if you touch it or move the affected area the pain will worsen.

Visceral Pain – a type of nociceptive pain. It is felt in the internal organs and main body cavities. The cavities are divided into the thorax (lungs and heart), abdomen (bowels, spleen, liver and kidneys), and the pelvis (ovaries, bladder, and the womb). The pain receptors – nociceptors – sense inflammation, stretch and ischemia (oxygen starvation).

Visceral pain is more difficult to localize than somatic pain. The sensation is more likely to be a vague deep ache. Colicky and cramping sensations are generally types of visceral pain. Visceral pain commonly refers to some type of back pain – pelvic pain generally refers to the lower back, abdominal pain to the mid-back, and thoracic pain to the upper back (see below for the meaning of referred pain).

Nerve Pain or Neuropathic Pain

Nerve pain is also known as neuropathic pain. It is a type of non-nociceptive pain. It comes from within the nervous system itself. People often refer to it as pinched nerve, or trapped nerve. The pain can originate from the nerves between the tissues and the spinal cord (peripheral nervous system) and the nerves between the spinal cord and the brain (central nervous system, or CNS).

Neuropathic pain can be caused by nerve degeneration, as might be the case in a stroke, multiple-sclerosis, or oxygen starvation. It could be due to a trapped nerve, meaning there is pressure on the nerve. A torn or slipped disc will cause nerve inflammation, which will trigger neuropathic pain. Nerve infection, such as shingles, can also cause neuropathic pain.

Pain that comes from the nervous system is called non-nociceptive because there are no specific pain receptors. Nociceptive in this text means responding to pain. When a nerve is injured it becomes unstable and its signaling system becomes muddled and haphazard. The brain interprets these abnormal signals as pain. This randomness can also cause other sensations, such as numbness, pins and needles, tingling, and hypersensitivity to temperature, vibration and touch. The pain can sometimes be unpredictable because of this.

Sympathetic Pain

The sympathetic nervous system controls our blood flow to our skin and muscles, perspiration (sweating) by the skin, and how quickly the peripheral nervous system works.

Sympathetic pain occurs generally after a fracture or a soft tissue injury of the limbs. This pain is non-nociceptive – there are no specific pain receptors. As with neuropathic pain, the nerve is injured, becomes unstable and fires off random, chaotic, abnormal signals to the brain, which interprets them as pain.

Generally with this kind of pain the skin and the area around the injury become extremely sensitive. The pain often becomes so intense that the sufferer daren’t use the affected arm or leg. Lack of limb use after a time can cause other problems, such as muscle wasting, osteoporosis, and stiffness in the joints.

What is referred pain?

Also known as reflective pain. When pain is felt either next to, or at a distance from the origin of an injury it is called referred pain. For example, when a person has a heart attack, even though the affected area is the heart, the pain is sometimes felt around the shoulders, back and neck, rather than in the chest. We have known about referred pain for centuries, but we still do not know its origins and what causes it.

How do you measure pain?

It is virtually impossible to measure a person’s pain objectively. Most experts say that the best way to find out how much pain a person is enduring is by a subjective pain report. A comprehensive assessment of pain should include:

* The identification of all the pains.

* This must include the most important ones.

* The site, quality, and radiation of pain

* What factors aggravate and relieve the pain


* When the pain occurs throughout the day


* What impact the pain has on the person’s function


* What impact the pain has on the person’s mood


* The sufferers’ understanding of their pain

There are many different methods for measuring pain and its severity. Health care professionals say it is important to stick to whatever system or tool you chose for a specific patient all the way through. If a patient is unable to report his pain, such as an infant, or a person with dementia, there are a number of observational pain measures a doctor can use.

Here is a list of some pain measures used today:

* Numerical Rating Scales

* The patient is given a form which asks him to tick from 0 to 10 what his level of pain is. 0 is no pain, 5 is moderate pain, and 10 is the worst pain imaginable.

* Please rate the pain you have right now
0 2 3 4 5 6 7 8 9 10
No pain Moderate pain Worst pain imaginable

The Numerical Rating Scales are useful if you want to measure any changes in pain, as well as gauging the patient’s response to pain treatment. If the patient has dyslexia, autism, or is very elderly and has dementia this may not be the best tool (see the ones below).

Verbal Descriptor Scale

This type of scale exists in many different forms. The patient is asked questions and responds verbally choosing from such terms as mild, moderate, severe, no pain, mild pain, discomforting, distressing, horrible, and excruciating.

Elderly patients with cognitive impairment, very young children, and people who respond better to verbal stimuli tend to have better completion rates with this type of scale, compared to the written numerical scale. Children respond even better to the faces scale (description below).

Faces Scale

The patient sees a series of faces. The first one is calm and happy, the second less so, etc., and the final one has an expression of extreme pain. This scale is used mainly for children, but can also be used with elderly patients with cognitive impairment. Patients with autism may respond better to this type of approach – people with autism tend to respond to visual stimuli well.

Brief Pain Inventory

This is a much more comprehensive written questionnaire. Not only does it gauge current level of pain, but also records the peaks and troughs of pain during previous days, how pain has affected mood, activity, sleep patterns, and how the pain may have affected the patient’s interpersonal relationship. The questionnaire also has diagrams which the patient shades – the shaded parts being where the pain is located and where it is most severe.

McGill Pain Questionnaire

This questionnaire measures the intensity (severity) of the pain, the quality of the pain, mood, and understanding of the pain. It is also known as the McGill Pain Index. It is a scale of rating pain developed at McGill University by Melzack and Torgerson (1971).

Look at the 20 groups below.

Circle one word in each group that best describes your pain.
Circle only three words from Groups 1 to 10 that best describe your pain response.
Choose just two words in Groups 11 to 15 that best describe your pain.
Just pick the one in Group 16.
Finally, choose just one word from Groups 17-20.
You should now have seven words. Those seven words should be taken to your doctor. They will help describe both the quality and intensity of your pain

Group 1 – Flickering, Pulsing, Quivering, Throbbing, Beating, Pounding
Group 2 – Jumping, Flashing, Shooting
Group 3 – Pricking, Boring, Drilling, Stabbing
Group 4 – Sharp, Gritting, Lacerating
Group 5 – Pinching, Pressing, Gnawing, Cramping, Crushing
Group 6 – Tugging, Pulling, Wrenching
Group 7 – Hot, Burning, Scalding, Searing
Group 8 – Tingling, Itching, Smarting, Stinging
Group 9 – Dull, Sore, Hurting, Aching, Heavy
Group 10 – Tender, Taunt, Rasping, Splitting
Group 11 – Tiring, Exhausting
Group 12 – Sickening, Suffocating
Group 13 – Fearful, Frightful, Terrifying
Group 14 – Punishing, Grueling, Cruel, Vicious, Killing
Group 15 – Wretched, Binding
Group 16 – Annoying, Troublesome, Miserable, Intense, Unbearable
Group 17 – Spreading, Radiating, Penetrating, Piercing
Group 18 – Tight, Numb, Squeezing, Drawing, Tearing
Group 19 – Cool, Cold, Freezing
Group 20 – Nagging, Nauseating, Agonizing, Dreadful, Torturing

Measuring pain when the patient is cognitively impaired

In this case doctors say that the patient’s subjective pain report is the most effective and accurate way of evaluating pain. If the severely cognitively impaired patient is observed carefully it is possible to pick out clues as to the presence of pain, e.g. restlessness, crying, moaning, groaning, grimacing, resistance to care, reduced social interactions, increased wandering, not eating, and sleeping problems.
What are the treatments for pain?

An underlying disorder, if treated effectively, will also get rid of the pain, or at least reduce it. If you have an infection and take antibiotics, the antibiotics may get rid of that infection, resulting also in the elimination of pain. Even if an underlying problem can be treated, you may still need analgesics (pain relievers).

Analgesics are good at relieving nociceptive pain, but not neuropathic pain. Chronic pain – long-lasting pain – may need other non-drug treatments as well.

Opioid Analgesics

Opioid analgesics are also known as narcotics. These are the strongest painkillers and are commonly used after surgery, for cancer, broken bones, burns, and various other situations. Even though opioids are not commonly used to treat non-cancer pain, their usage for non-cancer pain is becoming more widespread and acceptable. Some patients do not respond well to opioids and should not take them.

The patient will be given opioids in gradually increasing dosages. The ideal dose is reached when the pain is relieved and the side-effects are tolerable (increase any higher and the side effects become too much for the patient). Dosages should be generally much lower for older patients and infants.

The patient is administered opioids every few hours – each dose coinciding with the moment just before the pain starts becoming severe. Some patients are given higher dosages if the pain becomes more intense, while others are given other medications alongside the opioid. Pain can become more intense if the patient needs to move about, or if a wound dressing needs to be changed.

The dosage goes down if the pain intensity drops, until if possible, the doctor switches to a non-opioid analgesic.

People with kidney failure, liver problems, COPD (chronic obstructive pulmonary disease, dementia, tend to have more side effects when given opioids. The most common opioid side effects are drowsiness, constipation, nausea, vomiting, and itching. Generally, the side effects lessen as after time. Taking too much opioid can be dangerous. Patients who take opioids for long period become physically dependent and will have withdrawal symptoms when treatment is stopped – it is important that their dosage is tapered off gradually.

Nonopioid Analgesics

Nonopioid analgesics are used generally for mild to moderate pain. They are not addictive and their pain-relieving effects do not dwindle over time.

NSAIDs (nonsteroidal anti-inflammatory drugs)

These may be obtained either OTC (over-the-counter) or as a prescription medication, it depends on the dosage. Low dosage NSAIDs are effective for headaches, muscle aches, fever, and minor pains. At a higher dose they help reduce joint inflammation. There are three main types of NSAIDs, and they all block prostaglandins – hormone-like substances that cause pain, inflammation, muscle cramps, and fever.



Traditional NSAIDs – the largest subset of NSAIDs. As is the case with most drugs, they do carry a risk of side-effects, such as stomach upset and gastrointestinal bleeding. The risk of side effects is significantly higher if the patient is over 60. At higher doses, they should only be taken when monitored by a doctor.




COX-2 inhibitors – these also reduce pain and inflammation. However, they are designed to have fewer stomach and gastrointestinal side-effects. In 22004/2005 Vioxx and Bextra were withdrawn from the market after major studies showed Vioxx carried increased cardiovascular risks, while Bextra triggered serious skin reactions. Some other COX-2 inhibitors are also being investigated for side-effects. The FDA told makers of NSAIDs to highlight warnings on their labels in a black box.




Salicylates – these include aspirin which continues to be a popular medication for many doctors and patients. If your plan to take aspirin more than just occasionally you should consult your doctor. Long term high dosage usage of aspirin carries with it a significant risk of serious undesirable side effects, such as kidney problems and gastrointestinal bleeding. For effective control of arthritis pain and inflammation frequent large doses are needed. Nonacetylated salicylate is designed to have fewer side effects than aspirin. Some doctors may prescribe nonacetylated salicylate if they feel aspirin is too risky for their patient. Nonacetylated salicylate does not have the chemical aspirin has which protects against cardiovascular disease. Some doctors prescribe low dose aspirin along with nonacetylated salicylate for patients who they feel need cardiovascular protection.

View drug information on
Bextra – http://www.medilexicon.com/drugs/bextra.php
Vioxx – http://www.medilexicon.com/drugs/vioxx.php

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FIBRO WHAT?

By Jeanne Hambleton © 2007

This weekend (8th September 2007) is the start of Fibromyalgia Awareness Week and I, for one, am pig sick of people saying “Fibro what?” when I tell them I have fibromyalgia.

I rang a travel insurance company to explain why I was falling apart at the seams so they would insure me for a trip abroad. When I said the “f” word, I followed this with, “Shall I spell it?” To my amazement she knew exactly what I was talking about. Now there is a first!

So apart from airline travel insurers we do need to let the rest of the world know, in this Fibromyalgia Awareness Week, why we look so well when we feel so ill with this invisible disability.

I am hopeful that you have already planned to do something to raise awareness this week – like putting banners all over your front garden – riding up and down the road with a sign saying you have the dreaded fibromyalgia – or something silly like that.

Maybe you just cannot put one foot in front of the other, or you are aching from head to foot, or maybe like me, the pain moves around the body so fast, it is difficult to know where it hurts most. But if this really is all too much trouble I can offer a solution to ease your conscience.

Are you in the mood to do your bit to raise awareness? If so, please spend less than 5 minutes adding your name to two e-petitions for the No.10 Downing Street website. If you have done nothing else, this is the very least you can do – oh and tell your friends and family. They do not need to have the dreaded FM to sign the petitions. We need at least 1,000 signatures please.

FIBROMYALGIA E PETITION

The first one is pressing the Prime Minister to find some funding to help fibromites.
Log on to this website, fill in your details and an email will arrive on your desktop seeking confirmation, which you click, and you have done your good deed.

http://petitions.pm.gov.uk/FIBROFUNDING/

We the undersigned petition the Prime Minister to allocate funds to help FIBROMYALGIA with research, finding a cure and raising awareness. We implore the new PRIME MINISTER to listen to those suffering with fibromyalgia, for which there is NO CURE, and provide financial help to help them survive – (as the Government has for ME). Who else can we ask for help?

CO-PROXAMOL E PETITION

The second one, new this week, concerns the disappearance of co-proxamol, which is a life line painkiller for most fibromites. Although this is due to be withdrawn at the end of December 2007 – due to an increase in the number of suicides with this drug and accidental poisoning by drinking alcohol with co-proxamol – this painkiller is already disappearing before time. It appears some manufacturers have already stopped making this painkiller, which has been prescribed by GPs since the 1950s.

http://petitions.pm.gov.uk/DISAPPEARANCE/

We the undersigned petition the Prime Minister to tell us why is CO-PROXAMOL disappearing now in September when it is not due to be withdrawn until December 2007? Our GPs say they cannot prescribe it, as the pharmacists can no longer obtain supplies of co-proxamol.

Caroline Flint, the Minister of State, Department of Health, told the House of Commons on 2nd May 2007, that when normal prescribing of co-proximal ended in December 2007, there would be flexibility to continue to prescribe in certain circumstances for people for whom co-proximal seems to be the only answer. TheyWorkForYou.com and Hansard reported the Minister also said she had confirmed with manufacturers that co-proxamol will continue after that date. The main manufacturer “has informed us that it is its firm intention to continue to manufacture co-proxamol following the cancellation of the licenses, so supplies will be assured.” But who is the ‘main manufacturer’ please so we can tell our pharmacists where to get their supplies. The MHRA would not release this information – something to do with confidentially – what confidentially? For heavens sake it is alleged they will have 72,000 customers. Co-proxamol has been prescribed as a safe painkiller since the 1950s and it is used by patients with fibromyalgia, arthritis and many more with painful conditions.

If only CO-PROXAMOL had become a controlled drug under Schedule 3 of the Misuse of Drugs Act 1971 instead of becoming unlicensed after the prescribing ban becomes effective. GPs would then be free to prescribe this painkiller for named patients without the possible threat of litigation, regardless of how strong the patient’s need for the drug. In reality how many GPs will wish to expose themselves to prescribing an unlicensed painkiller. At present the recommendations to withdraw co-proxamol amounts to a comprehensive ban.

I read one interesting comment where a patient suggested you offer to sign a disclaimer confirming you would not sue your doctor if he prescribed co-proxamol for you. Perhaps this is the way forward.

It is my understand that the medical profession has no problem with co-proxamol and are happy to prescribe this to “sensible” patients…. that of course is always supposing someone somewhere is STILL manufacturing co-proxamol or even distalgesic, which has the same ingredients.

We are now on count down and it really time to do something about this dilemma. Why not write to the Secretary for State for Health Alan Johnson – email: johnsona@parliament.uk but do remember to sign the petition first. Tell him where it hurts, why we need research and you cannot function with co-proxamol. That will do just great for raising awareness in this our special week.

Opioids for managing chronic non-malignant pain: safe and effective prescribing.

Kahan M, Srivastava A, Wilson L, Mailis-Gagnon A, Midmer D.
Addiction Medical Service, St Joseph’s Health Centre, Toronto, Ontario, Canada. kahanm@stjoe.on.ca

OBJECTIVE: To review the evidence on safe and effective prescribing of opioids for chronic non-malignant pain.

QUALITY OF EVIDENCE: MEDLINE was searched using the terms “opioid effectiveness” and “adverse effects.” There is strong evidence that opioids are effective for both nociceptive and neuropathic pain, but limited evidence that they are effective for pain disorder. There is little information on their effectiveness at high doses or on the adverse effects of high doses.

MAIN MESSAGE: Opioids should be initiated after an adequate trial of acetaminophen or nonsteroidal anti-inflammatory drugs for nociceptive pain and of tricyclic antidepressants or anticonvulsants for neuropathic pain. Patients should be asked to sign treatment agreements and to give informed consent to treatment. Patients should experience a graded analgesic response with each dose increase. Titrate doses of immediate-release opioids slowly upward until pain reduction is achieved, and then switch patients to controlled-release opioids. Most patients with chronic non-malignant pain can be managed with<300 mg/d of morphine (or equivalent).

CONCLUSION: Opioids are safe and effective for managing chronic pain.

PMID: 17279219 [PubMed - indexed for MEDLINE]

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Prevalence of Interpersonal Abuse in Primary Care Patients Prescribed Opioids for Chronic Pain.

Balousek S, Plane MB, Fleming M.

Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

BACKGROUND: Interpersonal abuse is associated with clinical problems including chronic pain disorders. OBJECTIVES: The objective of this study is to describe 30-day and lifetime prevalence of emotional, physical, and sexual abuse found in men and women prescribed opioids for chronic pain.

DESIGN: Cross-sectional interview is the design of this study.

PARTICIPANTS: Patients, 1,009, currently prescribed opioids for chronic noncancer pain. They were recruited from the practices of 235 Family Physicians and Internists in Wisconsin. The most common pain diagnoses were arthritis, low back pain, headache, and fibromyalgia/myofascial pain.

MEASUREMENT: Data for this secondary analysis on rates of interpersonal abuse were based on 3 questions from the Addiction Severity Index (ASI) regarding 30-day and lifetime emotional, physical, and sexual abuse.

RESULTS: Forty-seven percent of women and 22% of men reported a history of lifetime physical abuse. Thirty -five percent of women and 10% of men reported lifetime sexual abuse. Binary logistic regression identified the following variables associated with lifetime physical abuse: female gender (RR 2.81, CI 2.01-3.94), age 31-50 (RR1.77, CI 1.30-2.41), Caucasian (RR1.67, CI 1.19-2.35), increased psychiatric symptoms as measured by the ASI (RR 2.14, CI 1.56-2.94), and lifetime suicide attempts (RR 3.98, CI 2.76-5.74).
CONCLUSIONS: This study reports prevalence of abuse in both men and women prescribed opioids for chronic pain in primary care settings. Subjects who report experiencing interpersonal abuse also report significantly higher rates of suicide attempts and score higher on the ASI psychiatric scale. Screening patients taking opioids for chronic pain for interpersonal abuse may lead to a better understanding of contributors to their physical and mental health.

PMID: 17641933 [PubMed - as supplied by publisher]

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JRRD releases single-topic issue on pain and pain management

Effects of depression and pain severity on satisfaction in medical outpatients: Analysis of the Medical Outcomes Study, pg. 143

Patient satisfaction is a critical measure of healthcare quality. We performed this study to see how depression and pain severity affected patient satisfaction in medical outpatients. We analyzed data from the Medical Outcomes Study and found that pain was very common and patients with depression and pain were much more likely to be dissatisfied with their healthcare. These findings may also have care-delivery implications, should dissatisfaction indicate poorer quality of care. Further study is needed to determine the reasons for dissatisfaction with care in patients with depression and pain.

Veterans seeking treatment for posttraumatic stress disorder: “What about comorbid chronic pain” pg. 153

In veterans who were being treated for posttraumatic stress disorder (PTSD), many (66%) were also diagnosed with chronic pain problems by their doctors. This is the first study to show that people with PTSD have pain-related conditions according to their doctors. The veterans who told their primary care doctor that they had pain before PTSD treatment said that their pain was less during and after the PTSD treatment. However, this finding was based on a review of charts, so other reasons could also explain the improvement in pain symptoms. More research about treatment for veterans with pain and PTSD is needed.

Prevalence and correlates of posttraumatic stress disorder and chronic severe pain in psychiatric outpatients, pg. 167

This study contributes to the growing literature on the co-occurrence of posttraumatic stress disorder (PTSD) and chronic severe pain. We found moderate rates of PTSD (46%) and chronic severe pain (40%) in a sample of psychiatric outpatients. In addition, 24% of the sample had both disorders. We found that persons with both disorders were significantly different from those with neither disorder on all variables and that they had greater physical and psychosocial stressors. In addition, persons with either PTSD or chronic severe pain alone were more likely to have a chronic medical condition, higher ratings of psychiatric distress, and more stressful life events than those with neither disorder. Mental health treatment providers should routinely assess and develop management strategies for these two disorders in psychiatric outpatients.

Pain and combat injuries in soldiers returning from Operations Enduring Freedom and Iraqi Freedom: Implications for research and practice, pg. 179

Operations Enduring Freedom and Iraqi Freedom have resulted in a growing number of seriously injured soldiers evacuated to the United States for medical care. Trauma-related pain is almost always present among these war-injured soldiers. Several military and Department of Veterans Affairs programs have been implemented to improve pain care. We describe several of these new approaches. We also present data on the soldiers treated, the services provided, and the effects of treatment. Finally, we identify some of the challenges emerging from work with this population and recommend future research and practice priorities.

Efficacy of selected complementary and alternative medicine interventions for chronic pain, pg. 195

We review published research on commonly used complementary and alternative medicine (CAM) approaches to treating chronic pain. Our findings show that CAM therapies, as a group, have a mixed track record of efficacy. The modalities that have the best track records for pain management include biofeedback, hypnosis, and massage (mostly for low back pain and shoulder pain). In selecting a CAM modality, practitioners must weigh the pros and cons and tailor the interventions to the needs of patients with chronic pain. Other issues relevant to practitioners include additional time and energy investments, need for specialized training to administer the modality, side effects or potential toxic effects, safety in combining CAM and other modalities, likely acceptance by clients and the public, and ease of incorporation into traditional pain management practices.

Preliminary evaluation of reliability and criterion validity of Actiwatch-Score, pg. 223

Restoration of normal physical activity is a primary objective of most chronic pain rehabilitative interventions, yet few clinically practical objective measures of activation exist. We evaluated the measurement properties of the Actiwatch-Score (AW-S). We conducted separate trials to examine concordance between units when worn concurrently at the same and different body sites and to compare the AW-S with a validated optical three-dimensional motion-tracking system. The data indicate that the AW-S has excellent interunit reliability and good criterion validity, but its intersite reliability varies with activity type. These results suggest that this device, and those like it, warrants further investigation and is likely to yield valuable data regarding the optimal application of this technology.

A closer look at pain and hepatitis C: Preliminary data from a veteran population, pg. 231

Many veterans who have hepatitis C also experience pain. Researchers are learning how to care for patients who experience hepatitis C and pain. They are also learning how hepatitis C and pain can affect patients’ lives. We review research on the relationship between hepatitis C and pain. We also present findings from a survey given to patients at two Department of Veterans Affairs hospitals. Finally, we suggest how physicians and mental health providers can best care for patients with hepatitis C and pain.

Overview of the relationship between pain and obesity: “What do we know. Where do we go next” pg. 245

Many veterans who struggle with being overweight also experience pain. Researchers are beginning to learn more about how being overweight or obese can affect several health conditions, including pain. We reviewed recent research examining the relationship between pain and overweight/obesity to promote understanding of when, why, and how these conditions occur together. Additionally, we suggest ways researchers can better study the problem of weight and pain to help veterans who experience both.

Medical residents’ beliefs and concerns about using opioids to treat chronic cancer and noncancer pain: A pilot study, pg. 263

Chronic pain from conditions such as arthritis or nerve injuries may be disabling and poorly controlled with aspirin, acetaminophen (Tylenol), or ibuprofen (Advil). In selected cases, opioid analgesics (e.g., morphine), combined with other treatments, can safely and more effectively relieve pain and improve function. We surveyed less experienced doctors and found that they had many fears, concerns, and negative beliefs toward using opioids to treat noncancer pain such as low back pain. If other doctors share these feelings, finding ways to increase their comfort by identifying and treating patients who might safely benefit from opioids to reduce their suffering and disability is important.

Persistent benefits of rehabilitation on pain and life quality for nonambulatory patients with spinal epidural metastasis, pg. 271

We evaluated the long-term effects of a 2-week course of rehabilitation on people with paraplegia caused by cancer compressing the spinal cord. Twelve patients received rehabilitation that focused on transfers, skin care, bladder and bowel management, nutrition, and incentive spirometry. We compared these study patients with a historical control group of 30 patients who had paraplegia from cancer but did not receive rehabilitation. Subjects were followed until death. The study patients had less pain and depression and more satisfaction with life; these benefits persisted for the remainder of their lives. In contrast, the control patients had worsening pain levels, declining satisfaction with life, and higher pain medication use for the remainder of their lives. While our study suggests that rehabilitation benefits people with cancer-related spinal cord injury, it needs to be supported by a randomized study.

Pain and palliative medicine, pg. 279

Pain control is an important part of medical care for patients with advanced illnesses. We summarize available information on pain in different patient groups near the end of life and on developments using behavioral and physical therapy methods to treat pain. Clinical trials to treat pain in patients within healthcare systems are the next topic, followed by ideas on how information technology and clinical databases can be used to guide future patient care. Finally, we present perspectives on how pain control can be studied and further improved within healthcare systems.

Moving to new settings: Pilot study of families’ perceptions of professional caregivers’ pain management in persons with dementia, pg. 295

Pain in persons with severe dementia is often not recognized or treated because these persons cannot communicate their needs. Family caregivers are in the best position to provide information to hospital care personnel about the patients’ needs, including pain. Little research has evaluated the role of the family caregiver when patients move between care facilities. This study describes family caregivers’ experiences when their family members with dementia were admitted to unfamiliar care sites and provides the caregivers’ recommended changes to healthcare settings. This article is relevant to family members and healthcare professionals who care for persons with severe dementia.

Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents, pg. 305

More than 80% of nursing home residents have chronic pain, and of these, many are not getting adequate treatment. Good pain treatment begins with knowing how severe the pain is. Several different pain-intensity tools are available: one uses a number (0–10) scale, another uses words, and a third shows pictures of people in pain. We asked nursing home residents to rate their pain using all three scales. We wanted to know how the pain reported on one scale translated onto another scale. The 42,000 veterans who live in nursing homes and their families will benefit from this study.

Cognitive impairment and pain management: Review of issues and challenges, pg. 315

Research shows that pain is often not recognized in persons with communication problems related to brain disease. Older persons with dementia experience memory loss, and seriously ill and dying patients experience confusion. Treating pain will increase the comfort of all these persons. In this article, we review the types of problems that affect the brain and interfere with pain management, how pain is measured, what pain management approaches help, and future research needs. Those who care for adults with brain-related disease will find this article relevant.

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Now Available Online and in Print–http://www.rehab.research.va.gov

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Narrative review: the pathophysiology of fibromyalgia.

1: Ann Intern Med. 2007 May 15;146(10):726-34.

Abeles AM, Pillinger MH, Solitar BM, Abeles M.

New York University School of Medicine, New York University Hospital for Joint Diseases, and New York Harbor Healthcare System, New York, New York 10003, USA.

Primary fibromyalgia is a common yet poorly understood syndrome characterized by diffuse chronic pain accompanied by other somatic symptoms, including poor sleep, fatigue, and stiffness, in the absence of disease. Fibromyalgia does not have a distinct cause or pathology. Nevertheless, in the past decade, the study of chronic pain has yielded new insights into the pathophysiology of fibromyalgia and related chronic pain disorders. Accruing evidence shows that patients with fibromyalgia experience pain differently from the general population because of dysfunctional pain processing in the central nervous system. Aberrant pain processing, which can result in chronic pain and associated symptoms, may be the result of several interplaying mechanisms, including central sensitization, blunting of inhibitory pain pathways, alterations in neurotransmitters, and psychiatric comorbid conditions. This review provides an overview of the mechanisms currently thought to be partly responsible for the chronic diffuse pain typical of fibromyalgia.

PMID: 17502633 [PubMed - in process]

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Novel pharmacotherapy for fibromyalgia.

1: Expert Opin Investig Drugs. 2007 Jun;16(6):829-41.

Wood PB, Holman AJ, Jones KD.

Louisiana State University Health Sciences Center–Shreveport, Department of Family Medicine, Shreveport, LA 71130, USA. pwood@lsuhsc.edu

Fibromyalgia is a common disorder that is characterized by chronic widespread pain, tenderness to light palpation, fatigue and sleep disturbances. The present lack of a well-accepted model of the disorder has hampered progress towards adequate treatment. A review of potential models to explain the pathophysiology underlying its primary symptom (i.e., chronic widespread pain) lends insight on the therapeutic potential of novel therapies. Following this, a mechanistic evaluation of those medications that are under consideration for the treatment of the disorder is offered. Adequate treatment will be likely to involve the identification of biologic subgroups within the greater fibromyalgia construct. Key insights from basic research are the basis for increased optimism for effective relief among patients and clinicians.

PMID: 17501695 [PubMed - in process]

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Substance Use Disorders in a Primary Care Sample Receiving Daily Opioid Therapy

1: J Pain. 2007 May 10; [Epub ahead of print]

.Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD.
Department of Family Medicine, University of Wisconsin, Madison, Wisconsin.

The primary goal of this paper was to present a comprehensive picture of substance use disorders in a sample of patients receiving opioid therapy from their primary care physician. A second goal was to determine the relation of positive urine screens and aberrant drug behaviors to opioid use disorders. The study recruited 801 adults receiving daily opioid therapy from the primary care practices of 235 family physicians and internists in 6 health care systems in Wisconsin. The 6 most common pain diagnoses were degenerative arthritis, low back pain, migraine headaches, neuropathy, and fibromyalgia. The point prevalence of current (DSM-IV criteria in the past 30 days) substance abuse and/or dependence was 9.7% (n = 78) and 3.8% (30) for an opioid use disorder. A logistic regression model found that current substance use disorders were associated with age between 18 and 30 (OR = 6.17: 1.99 to 19.12), severity of lifetime psychiatric disorders (OR = 6.17; 1.99 to 19.12), a positive toxicology test for cocaine (OR = 5.92; 2.60 to 13.50) or marijuana (OR = 3.52; 1.85 to 6.73), and 4 aberrant drug behaviors (OR = 11.48; 6.13 to 21.48). The final model for opioid use disorders was limited to aberrant behaviors (OR = 48.27; 13.63 to 171.04) as the other variables dropped out of the model.

PERSPECTIVE: This study found that the frequency of opioid use disorders was 4 times higher in patients receiving opioid therapy compared with general population samples (3.8% vs 0.9%). The study also provides quantitative data linking aberrant drug behaviors to opioid use disorders.

PMID: 17499555 [PubMed - as supplied by publisher]

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FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

FOR IMMEDIATE RELEASE
P07-85
May 10, 2007
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA

Company Misrepresented Prescription Pain Reliever to Health Care Professionals
The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing “fewer peaks and valleys than with immediate-release oxycodone,” and by representing that “…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug.”

“FDA will not tolerate practices that falsely promote drug products and place consumers at health risk,” said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. “We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars.”

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

In addition, Purdue’s current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications.

This case was prosecuted by the U. S. Attorney’s Office for the Western District of Virginia and investigated by FDA’s Office of Criminal Investigations; the Internal Revenue Service’s Criminal Investigations Division; the U.S. Department of Health and Human Services’ Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.

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BEMA Fentanyl demonstrates substantial transmucosal delivery

Contact: Bill Douglass
bill@investorrelationsgroup.com
BioDelivery Sciences

Findings form a part of pending NDA for the treatment of breakthrough cancer pain findings form a part of pending NDA for the treatment of breakthrough cancer pain
Morrisville, North Carolina, May 7, 2007 — BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the results of a 12 subject, crossover study comparing the absorption of fentanyl from both single and multiple BEMA™ Fentanyl discs, as well as oral and intravenous doses of fentanyl. The data demonstrates that the absolute bioavailability (i.e. the total amount absorbed from the delivery system) of fentanyl through the BEMA disc was more than 70%, with 50% absorbed through the buccal mucosa (the inner lining of the cheek). The study further demonstrates that equal doses administered as either a single disc or multiple discs produced nearly identical plasma concentrations (i.e. two 200 mcg discs provided nearly equivalent plasma concentrations as one 400 mcg disc, etc.)

These findings follow the Company’s April 25, 2007 announcement of statistically significant results with BEMA Fentanyl in treating cancer patients with breakthrough pain in the company’s Phase III efficacy clinical trial. BDSI plans to include today’s study results, the efficacy trial results and other materials in its planned submission of a New Drug Application (NDA) to the FDA for BEMA Fentanyl. The NDA submission is expected during third quarter of 2007.

BEMA Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal membranes. Upon administration, BEMA Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes. BEMA Fentanyl is being developed for the treatment of “breakthrough” cancer pain (i.e. episodes of severe pain which “break through” the medication already in use to control the persistent pain).

Dr. Andrew Finn, Executive Vice President of Product Development for BDSI, stated “The results of this study confirm, and are an expansion of, the information obtained in our 2006 pharmacokinetic study which demonstrated that fentanyl absorption from the BEMA delivery system was better than that seen with Actiq®. This study showed that the absolute bioavailability from BEMA Fentanyl and the amount of fentanyl absorbed directly through the buccal mucosa was substantial (70% and 50%, respectively). Although the study announced today was not a direct comparative study, our bioavailability results are greater than those previously reported with Actiq® (50% and 22%), and similar to those previously reported with Fentora™ (65% and 48%). Given the linear increase in plasma concentrations with increases in dose, and the nearly identical plasma concentrations when a dose is administered as a single disc or with multiple discs, we believe doctors will have the needed flexibility in titrating the dose of BEMA Fentanyl to meet the changing analgesic requirements of patients with breakthrough cancer pain.”

Actiq®, marketed by Cephalon, Inc., is the leading fentanyl product for the treatment of breakthrough cancer pain in the U.S. market. Cephalon introduced a second fast dissolving fentanyl product, Fentora™, in 2006. The reported combined sales of these products in 2006 were $659 million.

Dr. Mark Sirgo, President and CEO of BDSI, stated “These results continue to demonstrate the consistency in the performance of the BEMA delivery system. The principal purpose of a transmucosal delivery system is to have the majority of the drug absorbed through that membrane, thereby allowing for a rapid onset of action while minimizing the amount of drug that is swallowed. Today’s results show that the BEMA technology and our BEMA Fentanyl product specifically meet this principle. These results, when combined with the recent announcement of achieving our primary efficacy endpoint in our breakthrough cancer pain Phase III efficacy study, give us continued confidence that the commercial value for BEMA Fentanyl remains on target with our expectations. In addition, we believe these continued positive findings with our BEMA technology lend support to the continued development of other products in the technology, including our next pain product in development, BEMA LA.”

###
About BEMA™ Fentanyl

BEMA™ Fentanyl is BDSI’s lead product in development. BDSI believes there is a clear need and growing market for additional agents in alternative dosage forms to provide rapid pain relief. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The transmucosal form of fentanyl is a powerful narcotic used to treat breakthrough cancer pain. BDSI believes that fentanyl applied with its BEMA™ disc technology has the potential to meet the market need for new narcotics and, BDSI believes, will be well suited for breakthrough cancer pain in opioid-tolerant patients.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner and commercialize, clinically-significant new products using proven therapeutics. BDSI’s pain franchise currently consists of two products in development utilizing the company’s patented BEMA™ oral adhesive disc technology: BEMA™ Fentanyl, a treatment for “breakthrough” cancer pain, and BEMA™ LA, a second analgesic with a target indication of the treatment of moderate to severe pain. The company is also working with both its BEMA™ technology and its patented Bioral® nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections. The company’s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit http://www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release and the statements of representatives of BioDelivery Sciences International, Inc. (the “Company”) related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects”, “may”, “could”, “would”, “should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, the application of funds, or the timing for completion and results of scheduled or additional clinical trials and FDA review of the Company’s formulations and products, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). Peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.

Contact:
Investor Relations Group
Investor Relations:
James Carbonara, 212-825-3210

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