Clinical trial NCT03597490: Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears
Official title: Effectiveness of Multimodal Physical Therapy Combined With Exercise in Partial-thickness Rotator Cuff Tears: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Partial Thickness Rotator Cuff Tear
Keywords: Partial Thickness Rotator Cuff Tear
Physical Therapy
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic nontraumatic partial thickness rotator cuff tear

Brief summary: The aim of this study is to investigate the early stage effectiveness of multimodal physical therapy with exercise in the conservative treatment of partial thickness rotator cuff tears.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain/function
timeFrame: Baseline to 6 months follow-up
Secondary outcomes:
measure: Disease specific health-related quality of life
timeFrame: Baseline to 6 months follow-up
Other outcomes:
measure: Active range of motion of shoulder joint
timeFrame: Baseline to 6 months follow-up
Locations:
city: İzmir
country: Turkey
facility: İlker Şengül
state: In The USA Or Canada, Please Select...
Study officials:
affiliation: İzmir Katip Çelebi University
name: ilker şengül
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.