A PROSPECTIVE, COMPARATIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ON THE EFFICACY OF RADIAL SHOCKWAVES IN THE TREATMENT OF MYOFASCIAL PAIN SYNDROME OF THE LUMBAR/GLUTEAL REGIONS
Bibliographic record
Abstract
BACKGROUND: Extracorporeal shockwave therapy (ESWT) has been used successfully in different musculoskeletal conditions, including pseudarthrosis and tendinopathies. However no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS). AIMS: The aim of the study was to evaluate the efficacy of radial ESWT (r - ESWT) in the treatment of MPS in the lumbar and gluteal regions. METHODS: The study was prospective, randomized, double-blind and placebo controlled. A total of 121 patients were enrolled and 46 patients were considered eligible based on inclusion and exclusion criteria (chronic low back pain, MPS lasting more than six months, DN4 < 4, VAS u2265 4). In the first phase, all patients were treated with a standard multidisciplinary protocol for six weeks (tricyclic antidepressant associated with physical therapy). After this phase, patients were reassessed with previously used questionnaires, 31 patients had VAS u2265 4 and moved to the r - ESWT phase. In the 2nd phase, they were randomized into 2 groups: active (n = 14) and control (n = 17). The patients underwent six ESWT sessions with an interval of one week between them. The parameters used in the radial shockwave device were: pulses = 1000 per trigger point or 2500 per muscle; frequency = 5 to 7 hertz; pressure = 3 bar (1st and 2nd sessions), 3.5 bar (3rd and 4th sessions), 4 bar (5th and 6th sessions). Evaluations were made after the first phase of conservative treatment and after ESWT (1.5, 3, 6 and 12 months). Pain intensity and functional disability were assessed using the VAS, Roland Morris Disability Questionnaire (RDQ), Oswestry Disability Index (ODI), Short-form McGill Pain Questionnaire (SF-MPQ). Trigger points were documented through thermography. RESULTS: Baseline characteristics of age, gender, VAS, RDQ, ODI, SF-MPQ were similar between groups. However, the duration of low back pain was significantly longer in the active r - ESWT group (p < 0.05).Three, six and 12 months after r - ESWT, the percentage of patients who had greater than 50% improvement in VAS in the active group was significantly higher than in the control group (Fig. 2). At the 12nd months of follow-up, the active group had significantly improvement in the functional disability of low back pain according to ODI (Fig. 3). CONCLUSIONS: The r - ESWT provided a significant and lasting reduction in pain intensity from the third until 12th month of follow up, finding that suggests that its analgesic effect settles late and has long duration. Additionally, r - ESWT pro-vided improvement of the functionality according to the ODI at the 12th month follow up.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.013 | 0.015 |
| Science and technology studies | 0.001 | 0.007 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.015 | 0.003 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; both teacher heads agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".