Condition category
Musculoskeletal Diseases
Date applied
15/02/2007
Date assigned
28/03/2007
Last edited
19/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Orest Szczurko

ORCID ID

Contact details

353 Thrace Ave
Mississauga
Ontario
L5B 2B2
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03

Study information

Scientific title

Acronym

NTRCTAPW

Study hypothesis

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

The research ethics board of the Canadian College of Naturopathic Medicine, approved on 30 October 2006

Study design

Randomized controlled parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Shoulder Pain And Disability Index (SPADI)

Secondary outcome measures

1. 36-item short form general health questionnaire (SF-36)
2. Shoulder range of movement
3. Orthopaedic shoulder tests

Overall trial start date

01/02/2007

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Canada

Trial participating centre

353 Thrace Ave
Ontario
L5B 2B2
Canada

Sponsor information

Organisation

The Canadian College of Naturopathic Medicine (Canada)

Sponsor details

1255 Sheppard Ave E
Toronto
Ontario
M2K 1E2
Canada

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes