Edward F. Owens

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial

BACKGROUND CONTEXT Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

Study Design. Randomized controlled trial. Objective. To assess changes in pain levels and physical functioning in response to standard medical care (SMC) versus SMC plus chiropractic manipulative therapy (CMT) for the treatment of low back pain (LBP) among 18 to 35-year-old active-duty military personnel. Summary of Background Data. LBP is common, costly, and a significant cause of long-term sick leave and work loss. Many different interventions are available, but there exists no consensus on the best approach. One intervention often used is manipulative therapy. Current evidence from randomized controlled trials demonstrates that manipulative therapy may be as effective as other conservative treatments of LBP, but its appropriate role in the healthcare delivery system has not been established. Methods. Prospective, 2-arm randomized controlled trial pilot study comparing SMC plus CMT with only SMC. The primary outcome measures were changes in back-related pain on the numerical rating scale and physical functioning at 4 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). Results. Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Mean numerical rating scale pain scores were also significantly better in the group that received CMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Conclusion. The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Head repositioning errors in normal student volunteers: a possible tool to assess the neck's neuromuscular system

BackgroundA challenge for practitioners using spinal manipulation is identifying when an intervention is required. It has been recognized that joint pain can interfere with the ability to position body parts accurately and that the recent history of muscle contraction can play a part in that interference. In this study, we tested whether repositioning errors could be induced in a normal population by contraction or shortening of the neck muscles.MethodsIn the experimental protocol, volunteers free of neck problems first found a comfortable neutral head posture with eyes closed. They deconditioned their cervical muscles by moving their heads 5 times in either flexion/extension or lateral flexion and then attempted to return to the same starting position. Two conditioning sequences were interspersed within the task: hold the head in an extended or laterally flexed position for 10 seconds; or hold a 70% maximum voluntary contraction in the same position for 10 seconds. A computer-interfaced electrogoniometer was used to measure head position while a force transducer coupled to an auditory alarm signaled the force of isometric contraction. The difference between the initial and final head orientation was calculated in 3 orthogonal planes. Analysis of variance (1-way ANOVA) with a blocking factor (participants) was used to detect differences in proprioceptive error among the conditioning sequences while controlling for variation between participants.ResultsForty-eight chiropractic students participated: 36 males and 12 females, aged 28.2 ± 4.8 yrs. During the neck extension test, actively contracting the posterior neck muscles evoked an undershoot of the target position by 2.1° (p <0.001). No differences in repositioning were found during the lateral flexion test.ConclusionThe results suggest that the recent history of cervical paraspinal muscle contraction can influence head repositioning in flexion/extension. To our knowledge this is the first time that muscle mechanical history has been shown to influence proprioceptive accuracy in the necks of humans. This finding may be used to elucidate the mechanism behind repositioning errors seen in people with neck pain and could guide development of a clinical test for involvement of paraspinal muscles in cervical pain and dysfunction.

Combined Multimodal Therapies for Chronic Tennis Elbow: Pilot Study to Test Protocols for a Randomized Clinical Trial

OBJECTIVE The objective of this project was to develop and test protocols for a randomized clinical trial (RCT) of 2 multimodal package therapies for chronic lateral epicondylitis. METHODS Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in group A and 2 in group B). Group A had high-velocity low-amplitude manipulation, high-voltage pulse galvanic stimulation, counterforce bracing, ice, and exercises, whereas group B had ultrasound, counterforce bracing, and exercise. Both groups had 12 weeks of active care and instructed to restrict usage of the affected elbow. Participants filled out a visual analog scale and the Patient Rated Tennis Elbow Evaluation every week. The pain-free grip strength test was measured at baseline, and at the end of the third, sixth, ninth, and twelfth visits. RESULTS One participant in group A dropped out before the end of care. Both groups demonstrated changes in all of the outcome variables from the baseline to the end point (12 weeks) of treatment. Sample size for a larger future randomized clinical trial was calculated as n = 246 participants. CONCLUSION The pilot study demonstrated that the study design is feasible and that patients could be recruited for a 12-week trial of multimodal treatment. A larger trial is warranted in a multicenter setting to detect differences in the effects of these treatment strategies.

Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.

Study Design. A three-arm controlled trial with adaptive allocation. Objectives. The aim of this study was to compare short-term effects of a side-lying, thrust spinal manipulation (SM) procedure and a nonthrust, flexion-distraction SM procedure in adults with subacute or chronic low back pain (LBP) over 2 weeks. Summary of Background Data. SM has been recommended in recently published clinical guidelines for LBP management. Previous studies suggest that thrust and nonthrust SM procedures, though distinctly different in joint loading characteristics, have similar effects on patients with LBP. Methods. Participants were eligible if they were 21 to 54 years old, had LBP for at least 4 weeks, scored 6 or above on the Roland-Morris disability questionnaire, and met the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force Classification for Spinal Disorders. Participants were allocated in a 3:3:2 ratio to four sessions of thrust or nonthrust SM procedures directed at the lower lumbar and pelvic regions, or to a 2-week wait list control. The primary outcome was LBP-related disability using Roland-Morris Disability Questionnaire and the secondary outcomes were LBP intensity using visual analog scale, Fear-Avoidance Beliefs Questionnaire, and the 36-Item Short Form Health Survey. The study was conducted at the Palmer Center for Chiropractic Research with care provided by experienced doctors of chiropractic. Clinicians and patients were not blinded to treatment group. Results. Of 192 participants enrolled, the mean age was 40 years and 54% were male. Improvement in disability, LBP intensity, Fear-Avoidance Beliefs Questionnaire—work subscale, and 36-Item Short Form Health Survey—physical health summary measure for the two SM groups were significantly greater than the control group. No difference in any outcomes was observed between the two SM groups. Conclusion. Thrust and nonthrust SM procedures with distinctly different joint loading characteristics demonstrated similar effects in short-term LBP improvement and both were superior to a wait list control. Level of Evidence: 2

Paraspinal Muscle Function Assessed with the Flexion-Relaxation Ratio at Baseline in a Population of Patients with Back-Related Leg Pain

OBJECTIVE The purpose of this study was to assess back muscle status at baseline in patients with back-related leg pain (BRLP) and to correlate those findings with baseline demographic and clinical factors. METHODS Surface electromyography (EMG) and electromagnetic motion-tracking detected flexion-relaxation response in 135 patients with BRLP. Surface EMG electrodes were attached with standard skin preparation over the right and left paraspinal muscles at L3. Participants moved from upright standing into full forward flexion, rested flexed for 1 second, and returned to the upright position. A flexion-relaxation ratio (FRR) factor was calculated as the root mean square EMG amplitude during forward flexion divided by the activity at full flexion. RESULTS High repeatability was found (intraclass correlation coefficient [ICC]([1,3]) = 0.94 and 0.86) between 3 cycles of assessment at the same session. Patients with BRLP exhibited low FRR values, indicating a loss of the flexion-relaxation response similar to that seen in low back pain patients. Patients with very low FRR had higher Roland-Morris Disability Questionnaire scores than the other patients, had increased incidence of straight leg raise test, and had decreased range and rate of forward flexion. CONCLUSIONS A subgroup of patients with BRLP was identified with very low FRR who exhibited more disability and clinical findings and decreased motion. The use of the inverted FRR factor, expressing muscle activity at the fully flexed and resting position as a percentage of peak activity during flexion, provides more stable numerical behavior and another perspective on interpreting FRRs.

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial.

BackgroundBack-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.Methods/DesignThis study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.DiscussionBack-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures.Trial RegistrationClinicalTrials.gov NCT00494065

Recruitment of research volunteers: methods, interest, and incentives.

College research departments use students as participants in trials and often receive course credit or other incentives, but sometimes challenges are found in recruiting participants without compensation. This commentary describes methods of recruitment for one study at Palmer Center for Chiropractic Research and comments from two other schools about how they recruit volunteers.

Effects of spinal manipulation on sensorimotor function in low back pain patients – A randomised controlled trial

BACKGROUND Low back pain (LBP) is a major health problem in industrialized societies. Spinal manipulation (SM) is often used for treating LBP, though the therapeutic mechanisms remain elusive. Research suggests that sensorimotor changes may be involved in LBP. It is hypothesized that SM may generate its beneficial effects by affecting sensorimotor functions. OBJECTIVES To compare changes in sensorimotor function, as measured by postural sway and response to sudden load, in LBP patients following the delivery of high-velocity low amplitude (HVLA)-SM or low-velocity variable amplitude (LVVA)-SM versus a sham control intervention. DESIGN A three-arm (1:1:1 ratio) randomized controlled trial. METHODS A total of 221 participants who were between 21 and 65 years, having LBP intensity (numerical rating scale) ≥4 at either phone screen or the first baseline visit and ≥2 at phone screen and both baseline visits, and Quebec Task Force diagnostic classifications of 1, 2, 3 or 7 were enrolled to receive four SM treatments over two weeks. Study outcomes were measured at the first and fifth visits with the examiners blinded from participant group assignment. RESULTS The LVVA-SM group demonstrated a significant increase in medial-to-lateral postural excursion on the soft surface at the first visit when compared to the control group. No other significant between-group differences were found for the two sensorimotor tests, whether during the first visit or over two weeks. CONCLUSIONS It appears that short-term SM does not affect the sensorimotor functions as measured by postural sway and response to sudden load in this study.

Low Back Pain Response to Pelvic Tilt Position: An Observational Study of Chiropractic Patients

OBJECTIVE The aim of this study was to look for differences between patients with an increased pain response as compared with those with a decreased pain response. METHODS Data were collected from consecutive new patients with lumbar or lumbopelvic pain in a chiropractic clinic. A pelvic tilt exercise was included in the initial examination, and pain response was noted. Analysis was made of pain and disability severity, as well as symptom location, chronicity, and other characteristics, before and after a course of chiropractic care. RESULTS Patients with an increased pain response to pelvic tilt (n = 12) had higher levels of pain and disability at baseline than patients without (n = 34). There were no between-group differences in other aspects of their complaints; in age, sex, or body mass; or in the types of care they received (eg, manipulation, stretching, exercise instruction). On the average, both groups of patients showed improvement with chiropractic care, and there was no detectable difference in improvement between groups. CONCLUSIONS This study found that patients experiencing pain in response to a pelvic tilt maneuver may have a poorer precare status than patients with a decreased pain response.