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

ISRCTN ISRCTN49884134
DOI https://doi.org/10.1186/ISRCTN49884134
Secondary identifying numbers 03
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

353 Thrace Ave
Mississauga
Ontario
L5B 2B2
Canada

Study information

Study designRandomized controlled parallel group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleNaturopathic Treatment of Rotator Cuff Tendonitis Amongst Postal Workers, a randomized controlled parallel group study
Study acronymNTRCTAPW
Study objectivesThis 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) studiedRotator cuff tendonitis
InterventionSupplement containing bromelain, rutin, and trypsin, and acupuncture vs placebo supplement with assisted, active, and resisted range of motion exercise
Intervention typeOther
Primary outcome measureShoulder Pain And Disability Index (SPADI)
Secondary outcome measures1. 36-item short form general health questionnaire (SF-36)
2. Shoulder range of movement
3. Orthopaedic shoulder tests
Overall study start date01/02/2007
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants80
Total final enrolment85
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2007
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

353 Thrace Ave
Ontario
L5B 2B2
Canada

Sponsor information

The Canadian College of Naturopathic Medicine (Canada)
University/education

1255 Sheppard Ave E
Toronto
Ontario
M2K 1E2
Canada

ROR logo "ROR" https://ror.org/03pjwtr87

Funders

Funder type

Other

Canada Post, The Canadian College of Naturopathic Medicine (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.