- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03597490
Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears
Effectiveness of Multimodal Physical Therapy Combined With Exercise in Partial-thickness Rotator Cuff Tears: a Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although partial thickness rotator cuff tear prevalence is greater than those of full-thickness tear, most studies on conservative treatment are associated with full-thickness tears. In general, any physical therapy modality alone is not effective in the treatment of rotator cuff tears. It has been reported that multimodal physiotherapy may be more successful than monotherapy, but evidence in this regard is inadequate. Therefore this observational prospective study aiming to investigate the effectiveness of physiotherapy in the treatment of rotator cuff tears was planned. The null hypothesis of this study is that multimodal physical therapy combined with exercise has no effect on pain and function in the treatment of partial thickness rotator cuff tears. The alternative hypothesis is the opposite.
Patients will be assessed by standardized measures in terms of pain and function (American Shoulder and Elbow Surgeons standardized shoulder form: patient self report section), active range of motion (goniometric measurement) and quality of life (Western Ontario rotator cuff index) at baseline and first, third and 6th months of follow-up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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In The USA Or Canada, Please Select...
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İzmir, In The USA Or Canada, Please Select..., Turkey, 35360
- İlker Şengül
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Symptomatic partial thickness rotator cuff tear verified with magnetic resonance imaging or ultrasound imaging
- Prescription of multimodal physical therapy with exercise by a clinician other than investigators prior to inclusion in the study
- Covered by the social security system
- Giving informed consent to include in the study
Exclusion Criteria:
- Age of under 50
- Full thickness rotator cuff tear
- Radicular pain
- Glenohumeral osteoarthritis
- Calcific tendonitis
- Adhesive capsulitis
- History of physiotherapy in last 6 months
- Prior surgical treatment
- Contraindication to physical therapy and/or exercises
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Partial thickness rotator cuff tear
Patients with symptomatic non-traumatic partial thickness rotator cuff tear treated with multimodal physical therapy with exercise
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Multimodal physical therapy will compose of thermotherapy (hot pack or cold pack) and electrotherapy (transcutaneous electrical nerve stimulation or interferential current) and therapeutic ultrasound (at least two of them).
Therapeutic exercise will compose of combination of range of motion, stretching, strengthening,neuromuscular and task specific exercises according to the clinical condition of patient under the supervision of a physiotherapist.
Additionally, all patients will be allowed to carry on home exercise program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain/function
Time Frame: Baseline to 6 months follow-up
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Pain and function are assessed by Turkish version of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section.
It consists of two subscales including pain (one item) and function section (ten items).
Pain and function subscales range between 0 and 50 with a maximum total score of 100.
Lower pain subscale score means more pain, and lower function subscale score means more functional loss.
The Turkish version of ASES standardized shoulder form:patient self reported section has been reported as reliable and valid.
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Baseline to 6 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease specific health-related quality of life
Time Frame: Baseline to 6 months follow-up
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Disease specific health-related quality of life is assessed by Turkish version of Western Ontario Rotator Cuff Index.The Turkish version of the WORC index has been found a reliable and valid measurement tool.
WORC index consists of 5 subscales including physical symptoms (6 items), sports and recreation (4 items), work (4 items), life style (4 items) and emotions (3 items).
Each item is estimated based on 0-100 mm visual analogue scale.
By summating the item scores, subscale scores and total scores are computed (possible total maximum score is 2100).
Lower scores represents higher quality of life.
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Baseline to 6 months follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active range of motion of shoulder joint
Time Frame: Baseline to 6 months follow-up
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All active range of motion measurements of affected shoulder joint will be performed with a standard universal goniometer.
While active range of motion of abduction and flexion (in degrees) will be measured in prone position, internal and external rotation measurement (in degrees) will be carried out in seating position while the shoulder is in 90 degrees abduction and elbow is in 90 degrees flexion.
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Baseline to 6 months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ilker şengül, Izmir Katip Celebi University
Publications and helpful links
General Publications
- Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
- Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
- Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.
- Matthewson G, Beach CJ, Nelson AA, Woodmass JM, Ono Y, Boorman RS, Lo IK, Thornton GM. Partial Thickness Rotator Cuff Tears: Current Concepts. Adv Orthop. 2015;2015:458786. doi: 10.1155/2015/458786. Epub 2015 Jun 11.
- Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.
- El O, Bircan C, Gulbahar S, Demiral Y, Sahin E, Baydar M, Kizil R, Griffin S, Akalin E. The reliability and validity of the Turkish version of the Western Ontario Rotator Cuff Index. Rheumatol Int. 2006 Oct;26(12):1101-8. doi: 10.1007/s00296-006-0151-2. Epub 2006 Jun 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.04.2018-150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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