Rotator cuff tendonitis Musculoskeletal Diseases tendonitis
Conditions
Interventions
Supplement containing bromelain, rutin, and trypsin, and acupuncture vs placebo supplement with assisted, active, and resisted range of motion exercise
Sponsors
The Canadian College of Naturopathic Medicine (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18-65 2. Mentally competent subjects able to adhere to the given protocol and treatments administered as interventions 3. Self-selected candidates identifying themselves to suffer from pain in at least one shoulder for a period of 6 weeks or more 4. Normal on physical examination at the pre-study intake, and in the case of abnormalities the medical practitioner considers them to be clinically insignificant 5. Written and informed consent 6. The potential candidate must have a family doctor that they have seen in the last 12 months 7. A negative pregnancy test for menstruating women and a willingness to practice adequate birth control for the duration of the trial 8. Symptoms consistent with rotator cuff tendonitis, as determined by medical history or examination at screening
Exclusion criteria
Exclusion criteria: 1. Mentally or physically incapacitated such that informed consent cannot be obtained 2. Any history or other condition which the study physician regards as clinically significant to the study 3. A major illness considered to be clinically significant by the study physician within 3 months of the study start date 4. Current participation in another intervention trial 5. Pregnancy or intent to become pregnant in the next 6 months 6. Medication at doses that is contraindicated with supplement (specifically daily use of warfarin, high dose aspirin, other blood thinners, or antibiotics) 7. Current alcoholism or substance abuse 8. Current history of tumors 9. Any current serious disorders determined to be clinically significant to the study 10. Breast feeding women 11. No prior shoulder surgeries, or scheduled surgeries of any kind 12. Haemophiliac, suffering from severe liver damage, or suffering from any hemorrhagic disease 13. Major shoulder joint pathology on assessment including full tendon rupture or degenerative joint disease. In these cases, referral for further evaluation and diagnosis will occur 14. Subjects with known sensitivity to any ingredient in the test product or to any member of the Bromeliaceae family, including pineapple 15. Subjects using Natural Health Products (NHPs) for 2 weeks prior to enrolment which affect shoulder pain or inflammation, contain phlogenzym or therapeutic constituents of the diet in supplement form 16. Current use of corticosteroid injection therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder Pain And Disability Index (SPADI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 36-item short form general health questionnaire (SF-36) 2. Shoulder range of movement 3. Orthopaedic shoulder tests | — |
Countries
Canada
Outcome results
None listed