BACKGROUND: We aimed to investigate whether the addition of non-steroidal anti-inflammatory drugs or spinal manipulative therapy, or both, would result in faster recovery for patients with acute low back pain receiving recommended first-line care. METHODS: 240 patients with acute low back pain who had seen their general practitioner and had been given advice and paracetamol were randomly allocated to one of four groups in our community-based study: diclofenac 50 mg twice daily and placebo manipulative therapy (n=60); spinal manipulative therapy and placebo drug (n=60); diclofenac 50 mg twice daily and spinal manipulative therapy (n=60); or double placebo (n=60). The primary outcome was days to recovery from pain assessed by survival curves (log-rank test) in an intention-to-treat analysis. This trial was registered with the Australian Clinical Trials Registry, ACTRN012605000036617. FINDINGS: Neither diclofenac nor spinal manipulative therapy appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy (diclofenac hazard ratio 1.09, 95% CI 0.84-1.42, p=0.516; spinal manipulative therapy hazard ratio 1.01, 95% CI 0.77-1.31, p=0.955). 237 patients (99%) either recovered or were censored 12 weeks after randomisation. 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations. Half of these patients were in the active diclofenac group, the other half were taking placebo. One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment. INTERPRETATION: Patients with acute low back pain receiving recommended first-line care do not recover more quickly with the addition of diclofenac or spinal manipulative therapy.
BACKGROUND CONTEXT: Acute back pain and sciatica are major sources of disability. Many medical interventions are available, including manipulations, with conflicting results.
PURPOSE: To assess the short- and long-term effects of spinal manipulations on acute back pain and sciatica with disc protrusion.
STUDY DESIGN/SETTING: Randomized double-blind trial comparing active and simulated manipulations in rehabilitation medical centers in Rome and suburbs.
PATIENT SAMPLE: 102 ambulatory patients with at least moderate pain on a visual analog scale for local pain (VAS1) and/or radiating pain (VAS2).
OUTCOME MEASURES: Pain-free patients at end of treatment; treatment failure (proportion of patients stopping the assigned treatment for lack of effect on pain); number of days with no, mild, moderate, or severe pain; quality of life; number of days on nonsteroidal anti-inflammatory drugs; number of drug prescriptions; VAS1 and VAS2 scores; quality of life and psychosocial findings; and reduction of disc protrusion on magnetic resonance imaging.
METHODS: Manipulations or simulated manipulations were done 5 days per week by experienced chiropractors, with a number of sessions which depended on pain relief or up to a maximum of 20, using a rapid thrust technique. Patients were assessed at admission and at 15, 30, 45, 90, and 180 days. At each visit, all indicators of pain relief were used.
RESULTS: A total of 64 men and 38 women aged 19-63 years were randomized to manipulations (53) or simulated manipulations (49). Manipulations appeared more effective on the basis of the percentage of pain-free cases (local pain 28 vs. 6%; p<.005; radiating pain 55 vs. 20%; p<.0001), number of days with pain (23.6 vs. 27.4; p<.005), and number of days with moderate or severe pain (13.9 vs. 17.9; p<.05). Patients receiving manipulations had lower mean VAS1 (p<.0001) and VAS2 scores (p<.001). A significant interaction was found between therapeutic arm and time. There were no significant differences in quality of life and psychosocial scores. There were only two treatment failures (manipulation 1; simulated manipulation 1) and no adverse events.
CONCLUSIONS: Active manipulations have more effect than simulated manipulations on pain relief for acute back pain and sciatica with disc protrusion.
Background: Conflicting evidence exists about the effectiveness of spinal manipulation. Objective: To validate a manipulation clinical prediction rule. Design: Multicenter randomized, controlled trial. Setting: Physical therapy clinics. Patients: 131 consecutive patients with low back pain, 18 to 60 years of age, who were referred to physical therapy. Intervention: Patients were randomly assigned to receive manipulation plus exercise or exercise alone by a physical therapist for 4 weeks. Measurements: Patients were examined according to the clinical prediction rule criteria (symptom duration, symptom location, fear-avoidance beliefs, lumbar mobility, and hip rotation range of motion). Disability and pain at 1 and 4 weeks and 6 months were assessed. Results: Outcome from spinal manipulation depends on a patient's status on the prediction rule. Treatment effects are greatest for the subgroup of patients who were positive on the rule (at least 4 of 5 criteria met); health care utilization among this subgroup was decreased at 6 months. Compared with patients who were negative on the rule and received exercise, the odds of a successful outcome among patients who were positive on the rule and received manipulation were 60.8 (95% CI, 5.2 to 704.7). The odds were 2.4 (CI, 0.83 to 6.9) among patients who were negative on the rule and received manipulation and 1.0 (CI, 0.28 to 3.6) among patients who were positive on the rule and received exercise. A patient who was positive on the rule and received manipulation has a 92% chance of a successful outcome, with an associated number needed to treat for benefit at 4 weeks of 1.9 (CI, 1.4 to 3.5). Limitations: The response rate for the 6-month follow-up resulted in inadequate power to detect statistically significant differences for some comparisons. Conclusions: The spinal manipulation clinical prediction rule can be used to improve decision making for patients with low back pain.
<b>STUDY DESIGN: </b>A multicenter assessor-blinded randomized clinical trial was conducted.<b>OBJECTIVES: </b>To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination.<b>Summary Of Background Data: </b>Both manipulative therapy and interferential therapy are commonly used treatments for low back pain. Evidence for the effectiveness of manipulative therapy is available only for the short-term. There is limited evidence for interferential therapy, and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy.<b>METHODS: </b>Consenting subjects (n = 240) recruited following referral by physicians to physiotherapy departments in the (government-funded) National Health Service in Northern Ireland were randomly assigned to receive a copy of the Back Book and either manipulative therapy (MT; n = 80), interferential therapy (IFT; n = 80), or a combination of manipulative therapy and interferential therapy (CT; n = 80). The primary outcome was a change in functional disability on the Roland Morris Disability Questionnaire. Follow-up questionnaires were posted at discharge and at 6 and 12 months.<b>RESULTS: </b>The groups were balanced at baseline for low back pain and demographic characteristics. At discharge all interventions significantly reduced functional disability (Roland Morris scale, MT: -4.53; 95% CI, -5.7 to -3.3 vs. IFT: -3.56; 95% CI, -4.8 to -2.4 vs. CT: -4.65; 95% CI, -5.8 to -3.5; P = 0.38) and pain (McGill questionnaire, MT: -5.12; 95% CI, -7.7 to -2.5 vs. IFT: -5.87; 95% CI, -8.5 to -3.3 vs. CT: -6.64; 95% CI, -9.2 to -4.1; P = 0.72) and increased quality of life (SF-36 Role-Physical, MT: 28.6; 95% CI, 18.3 to 38.9 vs. IFT: 31.4; 95% CI, 21.2 to 41.5 vs. CT: 30; 95% CI, 19.9 to 40; P = 0.93) to the same degree and maintained these improvements at 6 and 12 months. No significant differences were found between groups for reported LBP recurrence, work absenteeism, medication consumption, exercise participation, or healthcare use at 12 months (P > 0.05).<b>CONCLUSIONS: </b>For acute low back pain, there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone.
BACKGROUND: The adult lifetime incidence for low back pain is 75% to 85% in the United States. Investigating appropriate care has proven difficult, since, in general, acute pain subsides spontaneously and chronic pain is resistant to intervention. Subacute back pain has been rarely studied.
OBJECTIVE: To compare the relative efficacy of chiropractic adjustments with muscle relaxants and placebo/sham for subacute low back pain.
DESIGN: A randomized, double-blind clinical trial.
METHODS: Subjects (N = 192) experiencing low back pain of 2 to 6 weeks' duration were randomly allocated to 3 groups with interventions applied over 2 weeks. Interventions were either chiropractic adjustments with placebo medicine, muscle relaxants with sham adjustments, or placebo medicine with sham adjustments. Visual Analog Scale for Pain, Oswestry Disability Questionnaire, and Modified Zung Depression Scale were assessed at baseline, 2 weeks, and 4 weeks. Schober's flexibility test, acetaminophen usage, and Global Impression of Severity Scale (GIS), a physician's clinical impression used as a secondary outcome, were assessed at baseline and 2 weeks.
RESULTS: Baseline values, except GIS, were similar for all groups. When all subjects completing the protocol were combined (N = 146), the data revealed pain, disability, depression, and GIS decreased significantly (P <.0001); lumbar flexibility did not change. Statistical differences across groups were seen for pain, a primary outcome, (chiropractic group improved more than control group) and GIS (chiropractic group improved more than other groups). No significant differences were seen for disability, depression, flexibility, or acetaminophen usage across groups.
CONCLUSION: Chiropractic was more beneficial than placebo in reducing pain and more beneficial than either placebo or muscle relaxants in reducing GIS.
BACKGROUND: The effect of osteopathic manual therapy (i.e., spinal manipulation) in patients with chronic and subchronic back pain is largely unknown, and its use in such patients is controversial. Nevertheless, manual therapy is a frequently used method of treatment in this group of patients.
METHODS: We performed a randomized, controlled trial that involved patients who had had back pain for at least three weeks but less than six months. We screened 1193 patients; 178 were found to be eligible and were randomly assigned to treatment groups; 23 of these patients subsequently dropped out of the study. The patients were treated either with one or more standard medical therapies (72 patients) or with osteopathic manual therapy (83 patients). We used a variety of outcome measures, including scores on the Roland-Morris and Oswestry questionnaires, a visual-analogue pain scale, and measurements of range of motion and straight-leg raising, to assess the results of treatment over a 12-week period.
RESULTS: Patients in both groups improved during the 12 weeks. There was no statistically significant difference between the two groups in any of the primary outcome measures. The osteopathic-treatment group required significantly less medication (analgesics, antiinflammatory agents, and muscle relaxants) (P< 0.001) and used less physical therapy (0.2 percent vs. 2.6 percent, P<0.05). More than 90 percent of the patients in both groups were satisfied with their care.
CONCLUSIONS: Osteopathic manual care and standard medical care had similar clinical results in patients with subacute low back pain. However, the use of medication was greater with standard care.
We aimed to investigate whether the addition of non-steroidal anti-inflammatory drugs or spinal manipulative therapy, or both, would result in faster recovery for patients with acute low back pain receiving recommended first-line care.
METHODS:
240 patients with acute low back pain who had seen their general practitioner and had been given advice and paracetamol were randomly allocated to one of four groups in our community-based study: diclofenac 50 mg twice daily and placebo manipulative therapy (n=60); spinal manipulative therapy and placebo drug (n=60); diclofenac 50 mg twice daily and spinal manipulative therapy (n=60); or double placebo (n=60). The primary outcome was days to recovery from pain assessed by survival curves (log-rank test) in an intention-to-treat analysis. This trial was registered with the Australian Clinical Trials Registry, ACTRN012605000036617.
FINDINGS:
Neither diclofenac nor spinal manipulative therapy appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy (diclofenac hazard ratio 1.09, 95% CI 0.84-1.42, p=0.516; spinal manipulative therapy hazard ratio 1.01, 95% CI 0.77-1.31, p=0.955). 237 patients (99%) either recovered or were censored 12 weeks after randomisation. 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations. Half of these patients were in the active diclofenac group, the other half were taking placebo. One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment.
INTERPRETATION:
Patients with acute low back pain receiving recommended first-line care do not recover more quickly with the addition of diclofenac or spinal manipulative therapy.
