N/A
N=50
Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT00884065 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2009
Primary outcome: Primary: Change in Active Flexion Movement After Intervention Minus Baseline — 9.48; -1.92 Sexagesimal Degrees — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diacutaneous Fibrolysis (Other); Diacutaneous Fibrolysis (placebo) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Active Flexion Movement After Intervention Minus Baseline |
9.48; -1.92 | <0.01 sig |
| PRIMARY Change in Active Abduction Movement After Intervention Minus Baseline |
7.88; 0.64 | <0.01 sig |
| PRIMARY Change in Active extensión Movement After Intervention Minus Baseline |
2.08; 0.16 | >0.05 |
| PRIMARY Change in Active External Rotation After Intervention Minus Baseline |
0.76; 0.16 | >0.05 |
| PRIMARY Change in Active Internal Rotation After Intervention Minus Baseline |
4.50; 1.42 | <0.01 sig |
| SECONDARY Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline |
-9.20; -7.48 | >0.05 |
Summary
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.
Eligibility Criteria
Inclusion Criteria
- over 18 years of age
- being referred for treatment of painful shoulder (except for adhesive capsulitis)
- not having been previously treated with DF
Exclusion Criteria
- Damaged skin and/or cutaneous lesions in the shoulder area
- History of shoulder surgery
- Vascular abnormalities
- Platelet antiaggregant therapy
- Acute inflammatory condition of the shoulder (<1 week)
- Patients with a pending litigation or court claim
Data sourced from ClinicalTrials.gov (NCT00884065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.