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
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