Back Pain Clinical Trials, Diagnosis, and Treatment

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Back Pain

Back pain (also known as "dorsopathy") is pain felt in the back that may originate from the muscles, nerves, bones, joints or other structures in the spine.

The pain may be have a sudden onset or it can be a chronic pain, it can be felt constantly or intermittently, stay in one place or refer or radiate to other areas. It may be a dull ache, or a sharp or piercing or burning sensation. The pain may be felt in the neck (and might radiate into the arm and hand), in the upper back, or in the low back, (and might radiate into the leg or foot), and may include symptoms other than pain, such as weakness, numbness or tingling.

Back pain is one of humanity's most frequent complaints. In the U.S., acute low back pain (also called lumbago) is the fifth most common reason for all physician visits. About nine out of ten adults experience back pain at some point in their life, and five out of ten working adults have back pain every year.

The spine is a complex interconnecting network of nerves, joints, muscles, tendons and ligaments, and all are capable of producing pain. Large nerves that originate in the spine and go to the legs and arms can make pain radiate to the extremities.

Back pain can be a sign of a serious medical problem, although this is not most frequently the underlying cause:

Typical warning signs of a potentially life-threatening problem are bowel and/or bladder incontinence or progressive weakness in the legs. Patients with these symptoms should seek immediate medical care.
Severe back pain (such as pain that is bad enough to interrupt sleep) that occurs with other signs of severe illness (e.g. fever, unexplained weight loss) may also indicate a serious underlying medical condition, such as cancer.
Back pain that occurs after a trauma, such as a car accident or fall, should also be promptly evaluated by a medical professional to check for a fracture or other injury.
Back pain in individuals with medical conditions that put them at high risk for a spinal fracture, such as osteoporosis or multiple myeloma, also warrants prompt medical attention.

In general, however, back pain does not usually require immediate medical intervention. The vast majority of episodes of back pain are self-limiting and non-progressive. Most back pain syndromes are due to inflammation, especially in the acute phase, which typically lasts for two weeks to three months.

Current Research

For current research articles click - here

Underlying Causes

Transient back pain is likely one of the first symptoms of influenza.

Muscle strains (pulled muscles) are commonly identified as the cause of back pain, but muscle imbalances are by far the most common cause of low back pain. Pain from such an injury often remains as long as the muscle imbalances persist. The muscle imbalances cause a mechanical problem with the skeleton, building up pressure at points along the spine.

Another cause of acute low back pain is a Meniscoid Occlusion. The more mobile regions of the spine have invaginations of the synovial membrane that act as a quasi-meniscus. This is a cushion to help the bones move over each other smoothly. The synovial membrane is well supplied with blood and nerves. When it becomes pinched or trapped it can cause sudden severe pain. The pinching causes the membrane to become inflamed causing greater pressure and ongoing pain. Symptoms include severe low back pain that may be accompanied by muscle spasm, pain with walking, concentration of pain to one side, no rediculopathy (radiating pain down buttocks and leg. Relief should be felt with flexion, exacerbated with extension.

When low back pain lasts more than three months, or if there is more leg pain than back pain, a more specific diagnosis can usually be made. There are several common causes of low back pain and leg pain: for adults under age 50, these include spinal disc herniation and degenerative disc disease or isthmis spondylolisthesis; in adults over age 50, common causes also include osteoarthritis (degenerative joint disease) and spinal stenosis. Non-anatomical factors can also contribute to or cause back pain, such as stress, repressed anger, or depression. Even if there is an anatomical cause for the pain, if depression is present it should also be treated concurrently.

Back pain is frequently experienced when no underlying anatomical problem is apparent. Some believe this pain to be caused by tension myositis syndrome.

Treatment

The management goals when treating back pain are to achieve maximal reduction in pain intensity as rapidly as possible; to restore the individual's ability to function in everyday activities; to help the patient cope with residual pain; to assess for side-effects of therapy; and to facilitate the patient's passage through the legal and socioeconomic impediments to recovery. For many, the goal is to keep the pain to a manageable level in order to progress with rehabilitation, which then can lead to long term pain relief. Also, for some people the goal is to use non-surgical therapies to manage the pain and avoid major surgery, while for others surgery may be the quickest way to feel better.

Not all treatments work for all conditions or for all individuals with the same condition, and many find that they need to try several treatment options to determine what works best for them. The present stage of the condition (acute or chronic) is also a determining factor in the choice of treatment. Only a minority of back pain patients (most estimates are 1% - 10%) require surgery.

Heat therapy is useful for back spasms or other conditions. A meta-analysis of studies by the Cochrane Collaboration concluded that heat therapy can reduce symptoms of acute and sub-acute low-back pain. Some patients find that moist heat works best (e.g. a hot bath or whirlpool) or continuous low-level heat (e.g. a heat wrap that stays warm for 4 to 6 hours). Cold therapy (e.g. ice or cold pack application) is also effective at relieving back pain, especially for pain that occurs after certain activities (e.g. sports, gardening).
Medications, such as muscle relaxants, narcotics, non-steroidal anti-inflammatory drugs (NSAIDs/NSAIAs) or paracetamol (acetaminophen). A meta-analysis of randomized-controlled trials by the Cochrane Collaboration found that injection therapy, usually with corticosteroids, does not appear to help regardless of whether the injection is facet joint, epidural or a local injection. Accordingly, a study of intramuscular corticosteroids found no benefit.
Exercises can be an effective aproach, particularly when done under supervision of a professional such as a physical therapist. Generally, some form of consistent stretching and exercise is believed to be an essential component of most back treatment programs. However, one study found that exercise is also effective for chronic back pain, but not for acute pain. Another study found that back-mobilizing exercises in acute settings are less effective than continuation of ordinary activities as tolerated.
Physical therapy and exercise, including stretching and strengthening (with specific focus on the muscles which support the spine), often learned with the help of a health professional, such as a physical therapist. Physical therapy, when part of a 'back school', can improve back pain.
Massage therapy, especially from an experienced therapist, may help. Acupressure or pressure point massage may be more beneficial than classic (Swedish) massage.
Body Awareness Therapy such as the Feldenkrais Method has been studied in relation to Fibromyalgia and chronic pain and studies have indicated positive effects. Organized exercise programs using these therapies have been developed.
Manipulation, as provided by an appropriately trained and qualified chiropractor, osteopath, physical therapist, or a physiatrist. Studies of the effect of manipulation suggest that this aproach has a small benefit similar to other therapies and superior to sham.
Acupuncture has a small benefit for chronic back pain. The Cochrane Collaboration concluded that "for chronic low back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short-term only. Acupuncture is not more effective than other conventional and alternative treatments." More recently, a randomized controlled trial found a small benefit after 1 to 2 years.
Education, and attitude adjustment to focus on psychological or emotional causes (e.g. TMS) respondent-cognitive therapy and progressive relaxation therapy can reduce chronic pain.
Most people will benefit from assessing any ergonomic or postural factors that may contribute to their back pain, such as improper lifting technique, poor posture, or poor support from their bed or office chair, etc. Although this recommendation has not been tested, this intervention is a part of many 'back schools' which do help.

Surgery

There are a number of different types of spine surgery to treat a variety of back conditions. Surgery should be considered if a patient has a significant neurological deficit, or if they fail non-surgical therapy. Regarding the role of surgery for failed medical therapy in patients without a neurological deficit, by the Cochrane Collaboration concluded that "limited evidence is now available to support some aspects of surgical practice". The ongoing Spine Patient outcomes Research Trial (SPORT) is addressing the role of surgery [18]. Some of the more common forms of surgery are:

Discectomy/microdiscectomy, usually used to treat pain (especially pain that radiates down the arm or leg) from spinal disc herniations.
Spinal fusion, usually to treat chronic, severe pain from degenerative disc disease, spondylolisthesis, or deformity, such as from scoliosis.
Artificial disc replacement, a relatively new form of surgery in the U.S. but has been in use in Europe for decades, primarily used to treat low back pain from a degenerated disc.
Kyphoplasty and Vertebroplasty, minimally invasive procedures designed to treat pain from osteoporotic compression fractures and sometimes other forms of fracture, such as a fracture caused by certain types of cancer.
Spinal cord stimulation, where an electrical device is used to interrupt the pain signals being sent to the brain.

Other forms of surgery may be done as well, such as a laminectomy (for spinal stenosis), IDET (a minimally invasive surgery for disc pain), and more, but these are not as common.

Treatments With Uncertain or Doubtful Benefit

Injections, such as epidural steroid injections, facet joint injections, or prolotherapy have limited, if any, benefit.
Chemonucleolysis, injection of the enzyme chymopapain (derived from the papaya fruit tree) directly into the herniated disc. The purpose and result of this procedure is for the injected enzyme to decompose the prolapsed nucleus pulpous that is affecting the surrounding nerve root(s), which ultimately is the cause of the back and / or leg pain.
Cold compression therapy is advocated for a strained back or chronic back pain and is postulated to reduce pain and inflammation, especially after strenuous exercise such as golf, gardening, or lifting. However, a meta-analysis of randomized controlled trials by the Cochrane Collaboration concluded "The evidence for the application of cold treatment to low back pain is even more limited, with only three poor quality studies located. No conclusions can be drawn about the use of cold for low-back pain."
Bed rest is rarely recommended as it can exacerbate symptoms, and when necessary is usually limited to one or two days. Prolonged bed rest or inactivity is actually counterproductive, as the resulting stiffness leads to more pain.
Electrotherapy, such as a Transcutaneous Electrical Nerve Stimulator (TENS) has been proposed. Two randomized controlled trials found conflicting results. This has led the Cochrane Collaboration to conclude that there is inconsistent evidence to support use of TENS

(adapted from Wikipedia, the free encyclopedia http://en.wikipedia.org/wiki/Back_Pain)

Findings From Current Research

Plasma-Mediated Radiofrequency Ablation Assisted Percutaneous Cement Injection for Treating Advanced Malignant Vertebral Compression Fractures.

Authors: Georgy BA, Wong W.

Valley Radiology Consultants, Escondido, Calif.

BACKGROUND AND PURPOSE: Using percutaneous cement injection to treat vertebral compression fractures (VCF) stemming from advanced malignancy, particularly those showing posterior cortical defect and epidural extension, is associated with higher risk of complications compared with treating benign osteoporotic VCF. The purpose of this study was to examine the clinical feasibility of a technique designed to improve control of cement placement. MATERIALS AND METHODS: A prospective series of patients (n = 15) with metastatic lesions having epidural extension of tumor and/or cortical disruption were treated. The percutaneous procedure consisted of using a plasma-mediated radio-frequency-based device to etch a cavity within the affected vertebral body and filling the cavity and adjacent interstices with bone cement. Change in pain status was determined by asking the patient to grade back pain preoperatively and at the 2-4-week postprocedure examination using a visual analog scale. RESULTS: An adequate amount of cement was injected in all cases. Extraosseous extension of cement was observed in 4 cases (anterior cortex, n = 3; through neural foramen, n = 1) but was clinically inconsequential. No thermal or neuronal insult was observed during the procedure in any case. Thirteen of the 15 (87%) patients reported decreased pain. CONCLUSION: Dissolution of tissue rather than displacement to create a cavity before injecting bone cement permitted well-directed cement deposition into the compromised vertebral body, which may allow a safer procedure to be conducted in patients with advanced malignant VCF. Clinical benefits may include avoiding more extensive surgery and reducing the risk of complications associated with conventional bone cement injection procedures.

Journal: AJNR Am J Neuroradiol. 2007 Apr;28(4):700-5.
Adapted from PubMed; click here to access full journal article.

Towards a Functional Radiopaque Hydrogel for Nucleus Pulposus Replacement.

Authors: Boelen EJ, Koole LH, van Rhijn LW, van Hooy-Corstjens CS.

Center for Biomaterials Research, University of Maastricht, P.O. Box 616, 6200 MD Maastricht, The Netherlands.

Patients with severe back pain, attributed to a herniation of the nucleus pulposus of the intervertebral disc, can benefit from a replacement of only the nucleus pulposus, provided the annulus fibrosus is still functional. This study investigated four intrinsically radiopaque hydrogel biomaterials, which were designed specifically to replace the herniated nucleus pulposus. The important characteristic of these hydrogels is that they can be visualized entirely with both MRI and X-rays. The materials are based on copolymers of N-vinyl-2-pyrrolidinone (NVP) or 2-hydroxyethyl methacrylate (HEMA) and a radiopacity introducing monomer, 2-(4'-iodobenzoyl)-oxo-ethyl methacrylate (4IEMA). Two of the formulations also contain the chemical crosslinker allyl methacrylate (AMA). Physical-mechanical properties like the water-uptake, biocompatibility, stiffness, and fatigue and creep behavior were studied, while keeping an eye on the intended application. All four materials were designed with 5-6 mass % of iodine to ensure sufficient X-ray visibility between two vertebrae. It was found that the materials display appropriate stiffness and biocompatibility. The crosslinked materials hold most promise as a functional nucleus prosthesis, as they combine these properties also with high water content, fatigue resistance, and recovery after loading. (c) 2007 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2007.

Journal: J Biomed Mater Res B Appl Biomater. 2007 Apr 5
Adapted from PubMed; click here to access full journal article.

Percutaneous Transforaminal Lumbar Interbody Fusion for the Treatment of Degenerative Lumbar Instability.

Authors: Scheufler KM, Dohmen H, Vougioukas VI.

Department of Neurosurgery, University Medical Center Freiburg, Freiburg, Germany (Scheufler) Department of Neurosurgery, Hirslanden Medical Center, Aarau, Switzerland (Scheufler) Department of Neuropathology, University Medical Center Freiburg, Freiburg, Germany (Dohmen) (Vougioukas).

OBJECTIVE: Percutaneous spinal instrumentation techniques may be helpful to reduce approach-related morbidity inherent to conventional open surgery. This article reports technique, clinical outcomes, and fusion rates of percutaneous transforaminal lumbar interbody fixation (pTLIF). Results are compared with those of mini-open transforaminal lumbar interbody fixation (oTLIF) using a muscle splitting (Wiltse) approach. METHODS: pTLIF was performed in 43 patients with single-level and 10 patients with bi- or multilevel lumbar discopathy or degenerative pseudolisthesis resulting in axial back pain and claudication, pseudoradicular, or radicular symptoms. Decompression, discectomy, and interbody cage insertion were performed through 18-mm tubular retractors followed by percutaneous pedicle screw-rod fixation. Clinical outcome was assessed by early postoperative pain scores (visual analog score) and standardized functional outcome questionnaires (American Academy of Orthopedic Surgeons lumbar spine and Roland-Morris low back pain score). Fusion rates were assessed by thin-slice computed tomographic scan at 16 months. Clinical outcome, time in the operating room, intraoperative blood loss, and postoperative access-site pain were compared with an institutional reference series of 67 oTLIF procedures. RESULTS: Excellent and good clinical results were obtained in 46 (87%) out of 53 patients at 16 months. The time spent in the operating room was equivalent and the blood loss reduced compared with oTLIF (P < 0.01). There was no morbidity related to instrumentation. Postoperative pain was significantly lower after pTLIF after the second postoperative day (P < 0.01). The overall clinical outcome was not different from oTLIF at 8 and 16 months. CONCLUSION: pTLIF allows for safe and efficient minimally invasive treatment of single and multilevel degenerative lumbar instability with good clinical results. Further prospective studies investigating long-term functional results are required to assess the definitive merits of percutaneous instrumentation of the lumbar spine.

Journal: Neurosurgery. 2007 Apr;60(4 Suppl 2):203-213.
Adapted from PubMed; click here to access full journal article.

Key Factors in Back Disability Prevention: A Consensus Panel on Their Impact and Modifiability.

Authors: Guzman J, Hayden J, Furlan AD, Cassidy JD, Loisel P, Flannery J, Gibson J, Frank JW.

From the *Institute for Work & Health, Toronto, Ontario, Canada; daggerToronto Rehabilitation Institute, Toronto, Ontario, Canada; double daggerDepartment of Medicine University of Toronto, Toronto, Ontario, Canada; section signUniversity Health Network Rehabilitation Solutions, Toronto, Ontario, Canada; parallelDivision of Outcomes and Population Health, Toronto Western Research Institute, Toronto, Ontario, Canada; paragraph signDepartment of Public Health Sciences, University of Toronto, Toronto, Ontario, Canada; and **Department of Surgery, Division of Orthopedics, Sherbrooke University, Canada.

STUDY DESIGN: Modified Delphi panel using Q-methodology. OBJECTIVE: To reach consensus on the relative impact and modifiability of factors that might prevent participation restrictions in people with back pain as defined by the WHO International Classification of Functioning, Disability and Health. SUMMARY OF BACKGROUND DATA: Back disability prevention should focus on factors with large impact that are relatively easy to change and supported by most stakeholders. An evidence-based consensus panel can provide interim direction until definitive evidence is available. METHODS: Evidence summaries for 32 factors were used by 33 researchers and stakeholders in a 3-round Delphi process to rank the factors' relative impact and modifiability. Consensus was judged as strong (>85% of panel members), moderate (50%-84%), or low (33%-49%). RESULTS: Most available research focused on return to work and often left unexplored other participation domains and environmental factors at home. The panel had substantial disagreements, particularly on the impact of changes to physical functioning and activities required at work. After 3 rounds, there was strong consensus that care provider reassurance had a high impact. There was moderate consensus that expectation of recovery and decreased fears had a high impact. Back supports, care provider reassurance, and patient knowledge were deemed most modifiable. CONCLUSIONS: Until definitive evidence is available, back disability prevention interventions will likely need to address multiple factors simultaneously and emphasize efforts to improve care provider reassurance. Consensus findings may vary depending on the panel. Research on nonoccupational participation, environmental factors at home, and reasons for discordant interpretation of evidence is needed.

Journal: Spine. 2007 Apr 1;32(7):807-815.
Adapted from PubMed; click here to access full journal article.

Effectiveness of a Back Pain Prevention Program: A Cluster Randomized Controlled Trial in an Occupational Setting.

Authors: Ijzelenberg H, Meerding WJ, Burdorf A.

From the Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

STUDY DESIGN: A cluster randomized controlled trial and economic evaluation with a 12-month follow-up and with work department as the unit of randomization. OBJECTIVE: To evaluate the effectiveness of a prevention program for low back pain (LBP) in an occupational setting with an economic evaluation. SUMMARY OF BACKGROUND DATA: LBP accounts for high economic costs in Western societies. Little is known on the effectiveness and related costs and savings of prevention programs for LBP. METHODS: The study population consisted of workers in physically demanding jobs from 9 large companies located throughout The Netherlands. In each company, 2 comparable work units were randomly allocated, resulting in 18 clusters with 258 workers assigned to the intervention group and 231 workers to the control group. RESULTS: Results in our study did not show significant differences in effects or costs savings of the program. Indirect costs related to work absence and productivity losses accounted for the majority (84%) of total costs due to LBP. CONCLUSIONS: This study provides no evidence for the adoption of this worksite prevention program for LBP.

Journal: Spine. 2007 Apr 1;32(7):711-9.
Adapted from PubMed; click here to access full journal article.

Efficacy of Noradrenergic and Serotonergic Antidepressants in Chronic Back Pain: A Preliminary Concentration-Controlled Trial.

Authors: Atkinson JH, Slater MA, Capparelli EV, Wallace MS, Zisook S, Abramson I, Matthews SC, Garfin SR.

Departments of *Psychiatry, daggerAnesthesia, double daggerSurgery Services, VA San Diego Healthcare System, San Diego, CA; Departments of section signPsychiatry, parallelMathematics, paragraph signPediatrics, #Anesthesia and **Orthopedic Surgery, University of California, San Diego, La Jolla, CA.

OBJECTIVE: Although antidepressants are widely prescribed as analgesics in chronic back pain, their clinical pharmacology is not well established. Norepinephrine transporter blockade seems to be essential for analgesia, but optimal concentrations are unknown. Fixed-dose studies of serotonin reuptake inhibitors are generally negative, but such studies cannot be interpreted clearly because efficacy might be detected if concentration-response relationships were known. We evaluated (1) the feasibility of conducting a controlled-concentration study of a norepinephrine (desipramine) and a serotonin reuptake (fluoxetine) inhibitor and (2) the relationship between achieved concentrations and analgesic response. METHODS:: This single-center, 12-week, double-blind, prospective, controlled-concentration study randomized 121 chronic back pain patients without major depression to active placebo (benztropine mesylate) or to predetermined low, medium, or high concentrations of desipramine (targets were 50, 110, and 150 ng/mL, respectively) or fluoxetine (targets were 100, 200, and 400 ng/mL, respectively). Of these, 83 completed the trial: 38 withdrew primarily due to side effects. RESULTS: Manipulation check revealed significant overlap of assigned and achieved concentrations related to drug intolerability. Completers' analysis of achieved concentrations revealed reduction in pain intensity was significantly greater for low-concentration desipramine (<60 ng/mL, mean Descriptor Differential Scale [DDS], 4.5) compared with placebo (DDS 6.2), higher concentrations of desipramine (>60 ng/mL, DDS 7.9), and all concentrations of fluoxetine (P < 0.05, DDS 7.1). Significant improvement in everyday function mirrored findings for pain intensity. CONCLUSIONS: Preliminary evidence for a low-concentration "therapeutic window" for noradrenergic analgesia may warrant additional study.

Journal: J Clin Psychopharmacol. 2007 Apr;27(2):135-142.
Adapted from PubMed; click here to access full journal article.

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