aturopathic Treatment of Rotator Cuff Tendonitis Amongst Postal Workers, a randomized controlled parallel group study

Not Applicable

Completed

• Conditions: Rotator cuff tendonitis; Musculoskeletal Diseases; tendonitis

• Registration Number: ISRCTN49884134
• Lead Sponsor: The Canadian College of Naturopathic Medicine (Canada)

Brief Summary

2009 results in https://doi.org/10.1002/art.24675 (added 26/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-28
• Study Completion: 2007-08-01
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified