Condition category
Musculoskeletal Diseases
Date applied
23/11/2009
Date assigned
18/03/2010
Last edited
11/08/2011
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 Victoria Bombin

ORCID ID

Contact details

Ancaster Sports Medicine Clinic
1015 Golflinks Road
Ancaster
L9K 1L6
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0.01

Study information

Scientific title

The Efficacy of Acupuncture in Chronic Rotator Cuff Tendinitis: A Pilot Randomised Controlled Trial

Acronym

Study hypothesis

Is acupuncture is an effective method of treating chronic rotator cuff tendinitis?

Ethics approval

1. Hamilton Health Science Research Ethics Board, McMaster University, Canada approved on the 26th of February 2010 (ref: 09-607)
2. Approval pending from the Institutional Review Board, Mayo Clinic, USA

Study design

Multicentre 3 arm randomised active and placebo controlled double blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic rotator cuff tendinitis

Intervention

After informed consent, patients will be randomised to one of three groups.
1. Traditional needle acupuncture
2. Laser acupuncture
3. Sham laser acupuncture

On the same day, these patients will have a history taken and a physical examination performed to exclude other causes of shoulder pain. Each patient will be examined by two independent physicians. Patients who meet the diagnostic criteria of rotator cuff tendinitis as assessed by the two physicians will be selected to enter the study. Disagreements between these two physicians will be resolved at the committee meeting. If the disagreement is not resolved, a third opinion by a qualified physician will be obtained. Other patients who do not meet the criteria will be excluded and referred to their family physician.
All subjects are then given education about Codman pendulum shoulder exercises to prevent potential shoulder stiffness. Patients are strongly encouraged to continue to take ibuprofen 200 to 600 mg every 6 hours or acetaminophen 320 to 500 mg every 4 hours on an “as needed” basis. These instructions will be given by one of the evaluating physicians.
The patients in all three groups will have ten sessions of metal needle, laser, or sham laser acupuncture treatments over a five week period by the same treating physician as described in the blinding section. Ten treatments are used because of previous systematic review suggests that this is the minimum number of treatments needed to produce sustained clinical effects.

Traditional Acupuncture Group:
Patients in this group will have needle insertion to a depth of 10-35 mm. The needle is then manually twirled for 30 seconds or until patients feel a dull pressure and warmth feeling around the needle (deqi). The treatment sessions will last 20 minutes with needles manipulated at the 10 minute mark.
Laser groups:
A research assistant not involved in the treatment or data analysis will enter the room prior to each laser intervention and flip the switch to either “real treatment” or “placebo” according to the group the patient has been randomly assigned to. The patient and the treating physician will be blinded to this procedure and will enter the room only after the research assistant exits the area. The laser leads will then be applied to the same points used for the metal needle acupuncture group. The patient will remain hooked up to the machine for twenty minutes to produce 20 joules energy per point at 810 nm infrared laser.
The Shoulder Pain and Disability Index and the Oxford Analgesic Chart will be given before each treatment by the blinded research assistant. The assistants will also contact the patients at three and six months after completing their course of treatments. Each patient will keep a log of the amount of ibuprofen and acetaminophen used using the Oxford analgesic chart, which will be confirmed by the research assistant weekly. The patient will also fill out a form at the end of the treatment to document any adverse effects noted during treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physical function and pain status, assessed by the Shoulder Pain and Disability Index (SPADI) at baseline, 10 weeks (end of intervention) and 1 month post-intervention.

Secondary outcome measures

Amount of analgesics consumed, assessed by Oxford analgesic chart at baseline, 10 weeks (end of intervention) and 1 month post-intervention.

Overall trial start date

02/01/2010

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-70
2. Shoulder pain with abduction and aggravated by resistance testing (abduction, internal rotation, or external rotation)
3. Duration of pain ≥ 3 months
4. Willingness to travel to treatment centres and to be available for repeated follow-up phone calls

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 at each site: 60 total

Participant exclusion criteria

1. Receiving other modality of treatment aside from analgesics or non-steroidal anti-inflammatory drugs (NSAIDs)
2. Patients who have contraindication to NSAIDs such as ulcers or gastroesophageal bleeding
3. Unsettling legal or worker compensation claims

Recruitment start date

02/01/2010

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

Ancaster Sports Medicine Clinic
Ancaster
L9K 1L6
Canada

Sponsor information

Organisation

Ancaster Sports Medicine Clinc (Canada)

Sponsor details

c/o Dr. Victoria Bombin
1015 Golflinks Road
Ontario
Ancaster
L9K 1L6
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Magna Corporation (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