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Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears

Terminated
Conditions
Partial Thickness Rotator Cuff Tear
Interventions
Combination Product: Multimodal physical therapy with exercise
Registration Number
NCT03597490
Lead Sponsor
Izmir Katip Celebi University
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
3
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Partial thickness rotator cuff tearMultimodal physical therapy with exercisePatients with symptomatic non-traumatic partial thickness rotator cuff tear treated with multimodal physical therapy with exercise
Primary Outcome Measures
NameTimeMethod
Pain/functionBaseline to 6 months follow-up

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.

Secondary Outcome Measures
NameTimeMethod
Disease specific health-related quality of lifeBaseline to 6 months follow-up

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.

Trial Locations

Locations (1)

İlker Şengül

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İzmir, In The USA Or Canada, Please Select..., Turkey

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