Nicolas E. Walsh

A Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise for Chronic Low Back Pain

A number of treatments are widely prescribed for chronic back pain, but few have been rigorously evaluated. We examined the effectiveness of transcutaneous electrical nerve stimulation (TENS), a program of stretching exercises, or a combination of both for low back pain. Patients with chronic low back pain (median duration, 4.1 years) were randomly assigned to receive daily treatment with TENS (n = 36), sham TENS (n = 36), TENS plus a program of exercises (n = 37), or sham TENS plus exercises (n = 36). After one month no clinically or statistically significant treatment effect of TENS was found on any of 11 indicators of outcome measuring pain, function, and back flexion; there was no interactive effect of TENS with exercise. Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS (P not significant). The 95 percent confidence intervals for group differences excluded a major clinical benefit of TENS for most outcomes. By contrast, after one month patients in the exercise groups had significant improvement in self-rated pain scores, reduction in the frequency of pain, and greater levels of activity as compared with patients in the groups that did not exercise. The mean reported improvement in pain scores was 52 percent in the exercise groups and 37 percent in the nonexercise groups (P = 0.02). Two months after the active intervention, however, most patients had discontinued the exercises, and the initial improvements were gone. We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent benefit to that of exercise alone.

Positive sacroiliac screening tests in asymptomatic adults.

Study Design In a prospective, single-blinded study, the incidence of false-positive screening tests for sacroiliac joint dysfunction was investigated using the standing flexion, seated flexion, and Gillet tests in 101 asymptomatic subjects. Objectives This study determined if these commonly used sacroiliac screening tests can be abnormal in an asymptomatic population. Summary of Background Data The sacroiliac joint is a potential source of back and leg pain. One condition affecting this joint is termed sacroiliac joint dysfunction. Diagnosis of this is made primerily by physical examination using screening tests as preliminary diagnostic tools. These screening tests evaluate for asymmetry in sacroiliac motion due to a relative, unilateral hypomobility in one the sacroiliac joints. The specificity of these tests, however, has not been thoroughly evaluated in a well-selected asymptomatic population. Methods A single-blinded examiner performed the standing flexion, seated flexion, and Gillet tests on all subjects. An asymptomatic and a symptomatic group were studied. Results Overall, 20% of asymptomatic individuals had positive findings in one or more of these tests. The specific percentage of false positives are reported by test, age, sex, and side. Conclusion This study suggests that asymmetry in sacroiliac motion due to relative hypomobility as determined by these tests can occur in asymptomatic joints. Obviously, one should not rely solely on these tests to diagnose symptomatic sacroiliac dysfunction.

Normative model for cold pressor test

The cold pressor test elicits an emotional/motivational pain experience from the immersion of a limb in cold water. It has been widely used to evaluate (experimental and chronic) pain. However, normative models for quantification and comparison for pain tolerance have not previously been established. This study developed a normative mathematical model for pain tolerance using the cold pressor test with over 600 subjects. Norms for age, sex, and ethnic group were calculated. In addition, chronic pain patients were compared with painfree patients to determine normative differences in response. The results indicate that at any given age Anglo-Saxon males have the longest tolerance time followed by non-Anglo-Saxon males, Anglo-Saxon females, and finally non- Anglo-Saxon females. There is a consistent decrease in tolerance time as the male age increases and minimal change in tolerance time as the female age increases. Chronic pain patients exhibited the same type of pain response pattern as healthy volunteers when corrected for age, sex, and ethnocultural subgroup.

Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain

Therapeutic trials often attempt to “blind” patient and investigator to the true nature of treatments received, reducing the influences of conscious or subconscious prejudices. In drug trials, this is accomplished with placebo tablets, but blinding in trials of physical treatments is more problematic. This issue arose in a clinical trial of transcutaneous electrical nerve stimulation (TENS) for patients with chronic low back pain. Several study design features were incorporated to promote blinding: use of sham TENS units visually identical with real units, exclusion of potential subjects with previous TENS experience, avoidance of a crossover design and use of identical visit frequency, instructions and modifications in electrode placement. Subjects were asked not to discuss treatments with the clinicians who performed outcome assessments. Both patients and clinicians were asked to guess actual treatment assignments at the trials end. Every patient in the true TENS group believed the unit was functioning properly, but the degree of certainty varied. In the sham TENS group, 84% also believed they had functioning units, but their certainty was significantly less than in the active treatment group. Differences in patient perceptions did not affect compliance, as the two groups had similar dropout rates, appointment compliance, days of TENS use and daily duration of TENS use. Clinicians guessed treatments correctly 61% of the time (as opposed to 50% expected by chance), again suggesting partial success in blinding. These efforts at blinding may partly explain the negative trial results for TENS efficacy. We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner. Nonetheless, trials of physical treatments can achieve partial blinding with the techniques described here, and the success of blinding can be assessed with simple questions at study completion.

The influence of prophylactic orthoses on abdominal strength and low back injury in the workplace.

This study was designed to determine the effect of multimodal intervention and the prevention of back injury, and to evaluate the adverse side effects of using a lumbosacral corset in the workplace. Subjects were 90 male warehouse workers randomly selected from over 800 employees at a grocery distribution center. Subjects were assigned to three groups: true controls, no back school, no brace orthoses; back school only; and back school plus wearing a custom molded lumbosacral orthosis. Comparisons of pre-testing and 6-month follow-up posttesting for abdominal strength, cognitive data, work injury incidence and productivity and use of health care services were evaluated. Controls and training-only group showed no changes in strength productivity or lost time. Orthoses and training-group showed no changes in strength productivity or accident rate; however, they showed substantially less lost time. This study supports the concept of using education and prophylactic bracing to prevent back injury and reduce time loss. It appears that the use of intermittent prophylactic bracing has no adverse affects on abdominal muscle strength and may contribute to decreased lost time from work injuries.

ICF Core Sets for chronic widespread pain.

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for chronic widespread pain. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS The preliminary studies identified a set of 365 ICF categories at the second, third and fourth ICF levels with 143 categories on body functions, 45 on body structures, 125 on activities and participation and 125 on environmental factors. Thirty experts attended the consensus conference on chronic widespread pain (16 physicians with at least a specialization in physical and rehabilitation medicine, 4 rheumatologists, 2 psychiatrists, 5 physical therapists, one psychologist, one occupational therapist and 1 social worker). Altogether 65 second-level and 2 third-level categories were included in the Comprehensive ICF Core Set with 23 categories from the component body functions, one from body structures, 27 from activities and participation and 16 from environmental factors. The Brief ICF Core Set included a total of 24 second-level categories and 2 third-level categories with 10 on body functions, 10 on activities and participation and 6 on environmental factors. No body structures were included in the Brief ICF Core Set. CONCLUSION A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for chronic widespread pain. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Intravenous regional sympatholysis: A double-blind comparison of guanethidine, reserpine, and normal saline

This double-blind, randomized study was designed to compare the effectiveness of intravenous regional sympatholysis using guanethidine, reserpine and normal saline. Twenty-one patients with reflex sympathetic dystrophy of an upper or lower extremity were enrolled and received intravenous regional blockade (IVRB) with one of the three medications. There was significant pain relief in all three groups at 30 min. There were no significant differences among the three groups in the degree of pain relief, the number of patients obtaining pain relief in the 30 min after the block, or the number of patients reporting more than 50% pain relief for more than 24 hr. The saline groups high rate of pain relief could be partially due to a mechanism of tourniquet-induced analgesia.

Rehabilitation of landmine victims — the ultimate challenge

Antipersonnel landmines are often used indiscriminately and frequently result in injury or death of non-combatants. In the last 65 years, over 110 million mines have been spread throughout the world into an estimated 70 countries. Landmine victims use a disproportionately high amount of medical resources; the vast majority of incidents occur in regions and countries without a sophisticated medical infrastructure and with limited resources, where rehabilitation is difficult in the best of circumstances. It is suggested that only a quarter of the patients with amputation secondary to landmines receive appropriate care.

ICF Core Sets for osteoporosis.

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set and a Brief ICF Core Set for osteoporosis. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS The preliminary studies identified a set of 239 ICF categories at the second, third and fourth ICF levels with 72 categories on body functions, 41 on body structures, 81 on activities and participation, and 45 on environmental factors. Fifteen experts from 7 different countries attended the consensus conference on osteoporosis. Altogether 67 second-level and 2 third-level categories were included in the Comprehensive ICF Core Set with 15 categories from the component body functions, 7 from body structures, 21 from activities and participation, and 26 from environmental factors. The Brief ICF Core Set included a total of 22 second-level categories with 5 on body functions, 4 on body structures, 6 on activities and participation, and 7 on environmental factors. CONCLUSION A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for osteoporosis. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Advancements in the management of spine disorders

Spinal disorders and especially back and neck pain affect more people and have greater impact on work capacity and health-care costs than any other musculoskeletal condition. One of the difficulties in reducing the burden of spinal disorders is the wide and heterogeneous range of specific diseases and non-specific musculoskeletal disorders that can involve the spinal column, most of which manifest as pain. Despite, or perhaps because of its impact, spinal disorders remain one of the most controversial and difficult conditions for clinicians, patients and policymakers to manage. This paper provides a brief summary of advances in the understanding of back and neck pain over the past decade as evidenced in the current literature. This paper includes the following sections: a classification of spinal disorders; the epidemiology of spine pain in the developed and developing world; key advancements in biological and biomechanical sciences in spine pain; the current status of potential methods for the prevention of back and neck pain; rheumatological and systemic disorders that impact the spine; and evidence-based surgical and non-surgical management of spine pain. The final section of this paper looks to the future and proposes actions and strategies that may be considered by the international Bone and Joint Decade (BJD), by providers, institutions and by policymakers so that we may better address the burden of spine disorders at global and local levels.