Geisser 2005.
Methods | Country: USA. Funding: National Institute of Health. Blinding: outcome assessor. Recruited: 100 patients. Randomized: 100 patients. Followed: 72 patients. Analyses: MANOVA and MANCOVA for comparisons between groups. | |
Participants | Settings: University of Michigan Spine Program. Mean age: 40.7 years old. 41% female. 85% white. 34% not working due to pain. Pain duration: mean 76.9 months. 18% had previous surgery. Diagnoses: not reported. |
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Interventions | Massage: muscle energy technique (MET) weekly for five weeks. Experience of therapists: physical therapist with 12 years postgraduate training in manual medicine. * post‐treatment scores. (N = randomized, completed the study).
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Outcomes | * used in the meta‐analyses. Measures taken at baseline, then at the end of the 5th session (last visit). a. Pain: a1) pain rating scales (from McGill Questionnaire) and a2) Visual Analogue Scale (VAS)*. b. Function: b1) QBPDS* and b2) Interference subscale of the Multidimensional Pain Inventory (MPI). c. Overall improvement: not measured. d. Patient satisfaction: four questions with seven‐point Likert scale. f. Adverse events: not measured. g. Costs: not reported. h. Work‐related: not measured. |
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Notes | a. Pain (VAS):
b. Function (Quebec):
c. Satisfaction with overall therapy:
Authors' conclusions: "massage therapy with specific adjuvant exercise appears to be beneficial in treating chronic low‐back pain. Despite changes in pain, perceived function did not improve". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear from text. "Participants were randomly assigned to 1 of 4 treatment conditions. To obtain equal numbers of patients in each group, the randomization order was determined prior to the study" |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes ‐ patients? | Low risk | "The treating therapist ...attempted to keep patients blind to their group assignment". Group 2: "sham manual therapy with specific adjuvant exercise (sham MT‐SE)". Group 4: "sham manual therapy and nonspecific exercise (sham MT‐NE)". |
Blinding (performance bias and detection bias) All outcomes ‐ providers? | High risk | "The treating therapist was not blind to the treatment group of the patient…" |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? | Low risk | "...the principal investigator, who was blind to the treatment condition of the patient". The outcomes are subjective, but the patients were kept blinded to the group they were assigned. |
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | Drop outs: 5 and 4 for each group. Reasons were not given. "The rate of attrition in the study was 28%". patients who dropped out of the study displayed significantly higher levels of pain and disability, were more likely to be receiving compensation, and were more likely to be male. |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | High risk | They analysed only 72 of the 100 randomized patients. No method for inputation of missing data was used. |
Selective reporting (reporting bias) | Unclear risk | All outcome variables were presented. PAIN: VAS, MPQ, DISABILITY: QBPDS, WELL BEING: Interference subscale of the Multidimensional Pain Inventory (MPI), SATISFACTION: 1) satisfaction with the feedback provided by the therapist about their condition; 2) satisfaction with the amount of pain relief from therapy; 3) overall satisfaction with therapy; and 4) overall satisfaction with the therapist. |
Other bias | Low risk | No other bias was identified. |
Similarity of baseline characteristics? | High risk | Although there are some big differences in the baseline characteristics presented in table 1, the authors conclude: "Chi‐square tests and ANOVA were used to compare the groups… no significant group differences were observed, although there was a trend for patients in the sham MT‐NE group to be older" Patient's age in the sham MT‐NE group was 46.3, while in the other groups it was: 39.3; 38.7 and 36.5." "According to the authors: "none". However, even though they were not statistically significant, the authors wisely used multivariate analyses and adjusted for baseline characteristics." |
Co‐interventions avoided or similar? | Unclear risk | 1. All patients were allowed to continue their use of pain medications, but were asked to not change their usage during the course of the study. 25 took no prescription medication for pain, 48 took NSAIDs, 35 took opioids, 25 were on antidepressants (for depression, analgesia, sleep disturbance or a combination of all these), 12 took antispasmodic medication and 8 were on anxiolytics and 6 took anticonvulsants. 2."...and were also given exercises specifically designed to treat identified musculoskeletal dysfunctions". 3. Examples of these exercises included: 1) quadriceps stretch; 2) double or single knee to chest stretch; 3) sitting hamstring stretch; and 4) prone on elbows. In addition, patients in this group were asked to perform aerobic exercise 3 times per week. Participants were free to choose how they performed aerobic exercise. 4. "...patients were asked to do stretches and/or self‐corrections twice daily (usually 10 repetitions each time). Patients were asked to hold each stretch for 30 seconds. |
Compliance acceptable? | Low risk | Not with massage, only with exercise. |
Timing outcome assessments similar? | Low risk | After 5th session (weekly sessions). "...Some patients rescheduled visits, prolonging the time between the first and last visit." It seems to be the same for both groups. |