One-year follow-up of a randomized clinical trial comparing flexion distraction with an exercise program for chronic low-back pain.

OBJECTIVE: Flexion distraction is a commonly used form of chiropractic care with chiropractor utilization rates of 58%. However, no previous randomized clinical trial has assessed the effectiveness of this form of care. The objective of this investigation was to compare the pain and disability during the year after active care based on treatment group allocation (Flexion Distraction versus Exercise Program). STUDY DESIGN: Randomized clinical trial, follow-up. SUBJECTS: Two hundred and thirty-five (235) subjects who were previously randomized to either chiropractic care (flexion distraction) or physical therapy (exercise program) within a clinical trial. OUTCOME MEASURES: Subjects were followed for 1 year via mailed questionnaires to assess levels of pain (Visual Analog Scale) and dysfunction (Roland Morris). RESULTS: Study subjects had a decrease in pain and disability after intervention regardless of which group they attended (p < 0.002), however, during the year after care, subjects who received chiropractic care (flexion distraction therapy) had significantly lower pain scores than subjects who received physical therapy (exercise program) (p = 0.02). CONCLUSIONS: In this first trial on flexion distraction care, flexion distraction was found to be more effective in reducing pain for 1 year when compared to a form of physical therapy.

Amount of health care and self-care following a randomized clinical trial comparing flexion-distraction with exercise program for chronic low back pain.

BACKGROUND: Previous clinical trials have assessed the percentage of participants who utilized further health care after a period of conservative care for low back pain, however no chiropractic clinical trial has determined the total amount of care during this time and any differences based on assigned treatment group. The objective of this clinical trial follow-up was to assess if there was a difference in the total number of office visits for low back pain over one year after a four week clinical trial of either a form of physical therapy (Exercise Program) or a form of chiropractic care (Flexion Distraction) for chronic low back pain. METHODS: In this randomized clinical trial follow up study, 195 participants were followed for one year after a four-week period of either a form of chiropractic care (FD) or a form of physical therapy (EP). Weekly structured telephone interview questions regarded visitation of various health care practitioners and the practice of self-care for low back pain. RESULTS: Participants in the physical therapy group demonstrated on average significantly more visits to any health care provider and to a general practitioner during the year after trial care (p < 0.05). No group differences were noted in the number of visits to a chiropractor or physical therapist. Self-care was initiated by nearly every participant in both groups. CONCLUSION: During a one-year follow-up, participants previously randomized to physical therapy attended significantly more health care visits than those participants who received chiropractic care.

A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain.

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.