Functional outcomes of low back pain: comparison of four treatment groups in a randomized controlled trial. A comparison between chiropractic management and pain clinic management for chronic low-back pain in a national health service outpatient clinic. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. Efficacy of treating low back pain and dysfunction secondary to osteoarthritis: chiropractic care compared with moist heat alone. The Hmax/Mmax ratio as an outcome measure for acute low back pain. A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial. A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain. A randomized trial of medical care with and without physical therapy and chiropractic care with and without physical modalities for patients with low back pain: 6-month follow-up outcomes from the UCLA low back pain study. A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments. Effectiveness of four conservative treatments for subacute low back pain: a randomized clinical trial.
The revised Oswestry Low Back Pain Questionnaire (ROLBPQ) and Roland-Morris Activity Scale (RMAS) were compared in a randomized controlled trial of chiropractic manipulation, stroking massage, corset and transcutaneous muscular stimulation (TMS). This trial employed specific inclusion and exclusion criteria, including nonspecific low back pain for a duration of 3 wk to 6 months and ages between 18 and 55. We had the opportunity to ask 85 patients to answer the questionnaires. Sixty-three patients, who completed the initial and final evaluations, were used for data analysis. Both ROLBPQ and RMAS showed good internal consistency with alpha coefficients ranging from .77 to .93. Both instruments showed a significant difference between the chiropractic manipulation and massage groups (p less than .05). RMAS was able to further show significant differences between the chiropractic manipulation and TMS groups, and between the corset and massage groups, but the ROLBPQ failed to do so. RMAS also showed that chiropractic manipulation had a better but nonsignificant result than corset, possibly due to insufficient sample size and/or duration of treatment. We conclude that both instruments are reliable for measuring low back pain disability, and chiropractic manipulation has a superior short-term benefit when compared to stroking massage and TMS in subacute low back pain patients. In addition, it appears that RMAS is preferable in a clinical trial situation for subacute low back pain because it is more sensitive than ROLBPQ to detect changes. To compare outcomes in perception of pain and disability for a group of patients suffering with chronic low-back pain (CLBP) when managed in a hospital by either a regional pain clinic or a chiropractor.
                The study was a pragmatic, randomized, controlled trial.
                The trial was performed at a National Health Service (NHS) hospital outpatient clinic (pain clinic) in the United Kingdom.
                Patients with CLBP (i.e., symptom duration of >12 weeks) referred to a regional pain clinic (outpatient hospital clinic) were assessed and randomized to either chiropractic or pain-clinic management for a period of 8 weeks. The study was pragmatic, allowing for normal treatment protocols to be used. Treatment was administered in an NHS hospital setting.
                The Roland-Morris Disability Questionnaire (RMDQ) and Numerical Rating Scale were used to assess changes in perceived disability and pain. Mean values at weeks 0, 2, 4, 6, and 8 were calculated. The mean differences between week 0 and week 8 were compared across the two treatment groups using Student's t-tests. Ninety-five percent (95%) confidence intervals (CIs) for the differences between groups were calculated.
                Randomization placed 12 patients in the pain clinic and 18 in the chiropractic group, of which 11 and 16, respectively, completed the trial. At 8 weeks, the mean improvement in RMDQ was 5.5 points greater for the chiropractic group (decrease in disability by 5.9) than for the pain-clinic group (0.36) (95% CI 2.0 points to 9.0 points; p = 0.004). Reduction in mean pain intensity at week 8 was 1.8 points greater for the chiropractic group than for the pain-clinic group (p = 0.023). Conclusions: This study suggests that chiropractic management administered in an NHS setting may be effective for reducing levels of disability and perceived pain during the period of treatment for a subpopulation of patients with CLBP. To compare chiropractic and hospital outpatient treatment for managing low back pain of mechanical origin.
                Randomised controlled trial. Allocation to chiropractic or hospital management by minimisation to establish groups for analysis of results according to initial referral clinic, length of current episode, history, and severity of back pain. Patients were followed up for up two years.
                Chiropractic and hospital outpatient clinics in 11 centres.
                741 Patients aged 18-65 who had no contraindications to manipulation and who had not been treated within the past month.
                Treatment at the discretion of the chiropractors, who used chiropractic manipulation in most patients, or of the hospital staff, who most commonly used Maitland mobilisation or manipulation, or both.
                Changes in the score on the Oswestry pain disability questionnaire and in the results of tests of straight leg raising and lumbar flexion.
                Chiropractic treatment was more effective than hospital outpatient management, mainly for patients with chronic or severe back pain. A benefit of about 7% points on the Oswestry scale was seen at two years. The benefit of chiropractic treatment became more evident throughout the follow up period. Secondary outcome measures also showed that chiropractic was more beneficial.
                For patients with low back pain in whom manipulation is not contraindicated chiropractic almost certainly confers worthwhile, long term benefit in comparison with hospital outpatient management. The benefit is seen mainly in those with chronic or severe pain. Introducing chiropractic into NHS practice should be considered. To evaluate the efficacy of chiropractic spinal manipulation, manual flexion/distraction, and hot pack application for the treatment of low back pain from osteoarthritis (OA) compared with moist heat alone.
                Two hundred fifty-two patients with low back pain secondary to OA were randomly assigned to either the treatment group (moist hot pack plus chiropractic care) or the moist heat group subjects, which attended 20 treatment sessions over several weeks. At sessions 1, 5, 10, 15, and 20, they rated pain using a visual analog pain scale, activities of daily living using the Oswestry Low Back Pain Questionnaire, and a range of motion (ROM) using the J-Tech Dual Digital Inclinometer (JTECH Medical Model no. AA036).
                Session I ratings indicated that the two groups were equivalent on all pain and flexion scores. The treatment group reported greater and more rapid pain reduction and greater and more rapid ROM improvement than the moist heat group. The treatment group also had greater improvements than the moist heat group in daily living activities in 4 of the 9 areas measured.
                Chiropractic care combined with heat is more effective than heat alone for treating OA-based lower back pain. Pain reduction occurs more rapidly and to a greater degree, and ROM increases more rapidly and to a greater degree. To evaluate the use of the Hmax/Mmax (H/M) ratio as an outcome measure for acute low back pain and to determine the change of this ratio in acute low back pain patients treated with spinal manipulation.
                Randomized clinical trial.
                Chiropractic college teaching clinic.
                Thirty-six patients with acute low back pain (pain of less than 2 wk duration) were referred by clinicians of the teaching clinic. Eligibility criteria for inclusion into the study consisted of the following: a score of eight or more on the Oswestry questionnaire, 33 mm or greater on a 100-mm visual analog scale, no involvement in litigation related to the low back pain complaint, patient not pregnant and no physical or electrodiagnostic signs of nerve root entrapment.
                The patients were randomly assigned to either a treatment or control group. The treatment group (n = 17) received treatment deemed appropriate by the clinician as long as it included a side-lying manipulation to the appropriate level. The control group (n = 19) received detuned ultrasound, application of a cold pack and 15-30 sec of very gentle soft tissue massage. Patients were treated three to five times over a period of 10 days and were subsequently reevaluated.
                The Hmax/Mmax ratio was calculated from the results of electrodiagnostic testing of the posterior tibial nerve. Extension/flexion ratio of the trunk musculature, Oswestry score and Visual Analog Scale score were also measured.
                The mean difference between H/M ratios pre- and postintervention for the group treated by chiropractic methods was -0.101 on the left and -0.117 on the right. The mean difference for the control group was 0.038 on the left and 0.036 on the right. Although not statistically significant, trends suggest that at the time of final assessment, the group receiving chiropractic care had improved more than the control group.
                The H/M ratio was found to be within normal limits in subjects with acute low back pain. The H/M ratio showed greater change in the group which received spinal manipulation, but the change was subtle. The results indicate that the H/M ratio may be of limited value in clinical practice. There are few data on the relative effectiveness and costs of treatments for low back pain. We randomly assigned 321 adults with low back pain that persisted for seven days after a primary care visit to the McKenzie method of physical therapy, chiropractic manipulation, or a minimal intervention (provision of an educational booklet). Patients with sciatica were excluded. Physical therapy or chiropractic manipulation was provided for one month (the number of visits was determined by the practitioner but was limited to a maximum of nine); patients were followed for a total of two years. The bothersomeness of symptoms was measured on an 11-point scale, and the level of dysfunction was measured on the 24-point Roland Disability Scale.
                After adjustment for base-line differences, the chiropractic group had less severe symptoms than the booklet group at four weeks (P=0.02), and there was a trend toward less severe symptoms in the physical therapy group (P=0.06). However, these differences were small and not significant after transformations of the data to adjust for their non-normal distribution. Differences in the extent of dysfunction among the groups were small and approached significance only at one year, with greater dysfunction in the booklet group than in the other two groups (P=0.05). For all outcomes, there were no significant differences between the physical-therapy and chiropractic groups and no significant differences among the groups in the numbers of days of reduced activity or missed work or in recurrences of back pain. About 75 percent of the subjects in the therapy groups rated their care as very good or excellent, as compared with about 30 percent of the subjects in the booklet group (P<0.001). Over a two-year period, the mean costs of care were $437 for the physical-therapy group, $429 for the chiropractic group, and $153 for the booklet group.
                For patients with low back pain, the McKenzie method of physical therapy and chiropractic manipulation had similar effects and costs, and patients receiving these treatments had only marginally better outcomes than those receiving the minimal intervention of an educational booklet. Whether the limited benefits of these treatments are worth the additional costs is open to question. To study the relative efficacy of three different treatment for chronic low back pain (CLBP). Two preplanned comparisons were made: (a) Spinal manipulative therapy (SMT) combined with trunk strengthening exercises (TSE) vs. SMT combined with trunk stretching exercises, and (b) SMT combined with TSE vs. nonsteroidal anti-inflammatory drug (NSAID) therapy combined with TSE.
                Interdisciplinary, prospective, observer-blinded, randomized clinical trial with a 1-yr follow-up period. The trial evaluated therapies in combination only and was not designed to test the individual treatment components.
                Primary contact, college out-patient clinic.
                In total, 174 patients aged 20-60 yr were admitted to the study.
                Patient-rated low back pain, disability, and functional health status at 5 and 11 wk.
                Five weeks of SMT or NSAID therapy in combination with supervised trunk exercise, followed by and additional 6 wk of supervised exercise alone.
                Individual group comparisons after 5 and 11 wk of intervention on all three main outcome measures did not reveal any clear clinically important or statistically significant differences. There seemed to be a sustained reduction in medication use at the 1-yr follow-up. in the SMT/TSE group. Continuance of exercise during the follow-up year, regardless of type, was associated with a better outcome.
                Each of the three therapeutic regimens was associated with similar and clinically important improvement over time that was considered superior to the expected natural history of long-standing CLBP. For the management of CLBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial and worthwhile. The magnitude of nonspecific therapeutic (placebo) effects, cost-effectiveness and relative risks of side effects associated with these types of therapy need to be addressed in future studies. Many clinical trials on chiropractic management of low back pain have neglected to include specific forms of care. This study compared two well-defined treatment protocols. The objective was to compare the outcome of flexion-distraction (FD) procedures performed by chiropractors with an active trunk exercise protocol (ATEP) performed by physical therapists. A randomized clinical trial study design was used. Subjects, 18 years of age and older, with a primary complaint of low back pain (>3 months) were recruited. A 100 mm visual analogue scale (VAS) for perceived pain, the Roland Morris (RM) Questionnaire for low back function, and the SF-36 for overall health status served as primary outcome measures. Subjects were randomly allocated to receive either FD or ATEP. The FD intervention consisted of the application of flexion and traction applied to specific regions in the low back, with the aid of a specially designed manipulation table. The ATEP intervention included stabilizing and flexibility exercises, the use of modalities, and cardiovascular training. A total of 235 subjects met the inclusion/exclusion criteria and signed the informed consent. Of these, 123 were randomly allocated to FD and 112 to the ATEP. Study patients perceived significantly less pain and better function after intervention, regardless of which group they were allocated to (P<0.01). Subjects randomly allocated to the flexion-distraction group had significantly greater relief from pain than those allocated to the exercise program (P=0.01). Subgroup analysis indicated that subjects categorized as chronic, with moderate to severe symptoms, improved most with the flexion-distraction protocol. Subjects categorized with recurrent pain and moderate to severe symptoms improved most with the exercise program. Patients with radiculopathy did significantly better with FD. There were no significant differences between groups on the Roland Morris and SF-36 outcome measures. Overall, flexion-distraction provided more pain relief than active exercise; however, these results varied based on stratification of patients with and without radiculopathy and with and without recurrent symptoms. The subgroup analysis provides a possible explanation for contrasting results among randomized clinical trials of chronic low back pain treatments and these results also provide guidance for future work in the treatment of chronic low back pain. A randomized clinical trial.
                To compare the effectiveness of medical and chiropractic care for low back pain patients in managed care; to assess the effectiveness of physical therapy among medical patients; and to assess the effectiveness of physical modalities among chiropractic patients.
                Despite the burden that low back pain places on patients, providers, and society, the relative effectiveness of common treatment strategies offered in managed care is unknown.
                Low back pain patients presenting to a large managed care facility from October 30, 1995, through November 9, 1998, were randomly assigned in a balanced design to medical care with and without physical therapy and to chiropractic care with and without physical modalities. The primary outcome variables are average and most severe low back pain intensity in the past week, assessed with 0 to 10 numerical rating scales, and low back-related disability, assessed with the 24-item Roland-Morris Disability Questionnaire.
                Of 1,469 eligible patients, 681 were enrolled; 95.7% were followed through 6 months. The mean changes in low back pain intensity and disability of participants in the medical and chiropractic care-only groups were similar at each follow-up assessment (adjusted mean differences at 6 months for most severe pain, 0.27, 95% confidence interval, -0.32-0.86; average pain, 0.22, -0.25-0.69; and disability, 0.75, -0.29-1.79). Physical therapy yielded somewhat better 6-month disability outcomes than did medical care alone (1.26, 0.20-2.32).
                After 6 months of follow-up, chiropractic care and medical care for low back pain were comparable in their effectiveness. Physical therapy may be marginally more effective than medical care alone for reducing disability in some patients, but the possible benefit is small. To evaluate the proposed manual placebo in terms of success in blinding patients to treatment group assignment and outcomes between the treatment groups.
                Randomized controlled trial.
                A chiropractic college research clinic in the midwestern United States.
                One hundred and eleven (111) individuals aged 18 years and over with subacute or chronic lowback pain.
                The active treatment consisted of flexion-distraction chiropractic manipulation and trigger point therapy and the control treatment of sham manipulation and effleurage; both groups received eight treatments over a 3-week period. The application of prescribed ranges of biomechanical forces for each treatment was standardized using specialized computerized equipment. "Nontreatment" aspects of the clinical encounter were to be standardized across groups. A primary clinician blinded to treatment assignment provided interpersonal interactions and treating clinicians delivered treatments with a minimum of interaction.
                The accuracy of the patient's perception of group assignment at visit 4 and the mean change in the Pain Disability Index (PDI) over the treatment period were the primary outcome variables.
                Patients in the control group were more likely to perceive their treatment assignment accurately than those in the active group (78% versus 54%, respectively). Patients in both treatment groups improved on the PDI and the Roland-Morris Questionnaire; there were no significant differences in improvement between the groups. Age, gender, prior chiropractic experience and expectation of treatment at baseline had no effect on outcomes.
                Patients in the control group were not successfully blinded; however, patients' perceptions of treatment group assignment did not significantly affect outcomes. The clinically significant improvement in both groups, independent of patient or clinician expectations, suggests the presence of therapeutic factors common to both groups, other than biomechanical force. Further studies examining other aspects of the clinical encounter, considered separately from biomechanical force, are warranted before arbitrarily designating any intervention as a "placebo." A randomized, assessor-blinded clinical trial was conducted.
                To investigate the relative effectiveness of three manual treatments and back school for patients with subacute low back pain.
                Literature comparing the relative effectiveness of specific therapies for low back pain is limited.
                Among the 5925 inquiries, 206 patients met the specific admission criteria, and 200 patients randomly received one of four treatments for 3 weeks: back school, joint manipulation, myofascial therapy, and combined joint manipulation and myofascial therapy. These patients received assessments at baseline, after 3 weeks of therapy, and 6 months after the completion of therapy. The primary outcomes were evaluated using visual analog pain scales and Roland-Morris activity scales.
                All four groups showed significant improvement in pain and activity scores after 3 weeks of care, but did not show further significant improvement at the 6-month follow-up assessment. No statistically significant between-group differences were found either at the 3-week or 6-month reassessments.
                For subacute low back pain, combined joint manipulation and myofascial therapy was as effective as joint manipulation or myofascial therapy alone. Additionally, back school was as effective as three manual treatments.
Combined chiropractic interventions slightly improved pain and disability in the short-term and pain in the medium-term for acute and subacute LBP. However, there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with LBP when compared to other interventions. Future research is very likely to change the estimate of effect and our confidence in the results.