Naturopathic Treatment of Rotator Cuff Tendonitis Amongst Postal Workers, a randomized controlled parallel group study
| ISRCTN | ISRCTN49884134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49884134 |
| Protocol serial number | 03 |
| Sponsor | The Canadian College of Naturopathic Medicine (Canada) |
| Funder | Canada Post, The Canadian College of Naturopathic Medicine (Canada) |
- Submission date
- 15/02/2007
- Registration date
- 28/03/2007
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Orest Szczurko
Scientific
Scientific
353 Thrace Ave
Mississauga
Ontario
L5B 2B2
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled parallel group study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Naturopathic Treatment of Rotator Cuff Tendonitis Amongst Postal Workers, a randomized controlled parallel group study |
| Study acronym | NTRCTAPW |
| Study objectives | This study aims to evaluate the difference in efficacy between the treatment of rotator cuff tendonitis with acupuncture, dietary advice and a supplement containing bromelain, trypsin, and rutosin vs placebo supplement with assisted, active, and resisted range of motion exercise |
| Ethics approval(s) | The research ethics board of the Canadian College of Naturopathic Medicine, approved on 30 October 2006 |
| Health condition(s) or problem(s) studied | Rotator cuff tendonitis |
| Intervention | Supplement containing bromelain, rutin, and trypsin, and acupuncture vs placebo supplement with assisted, active, and resisted range of motion exercise |
| Intervention type | Other |
| Primary outcome measure(s) |
Shoulder Pain And Disability Index (SPADI) |
| Key secondary outcome measure(s) |
1. 36-item short form general health questionnaire (SF-36) |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 85 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
353 Thrace Ave
Ontario
L5B 2B2
Canada
L5B 2B2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/08/2009 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
