Skip to main content
Clinical Trials/NCT03597490
NCT03597490
Terminated
Not Applicable

Effectiveness of Multimodal Physical Therapy Combined With Exercise in Partial-thickness Rotator Cuff Tears: a Prospective Observational Study

Izmir Katip Celebi University1 site in 1 country3 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Partial Thickness Rotator Cuff Tear
Sponsor
Izmir Katip Celebi University
Enrollment
3
Locations
1
Primary Endpoint
Pain/function
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
May 16, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Izmir Katip Celebi University
Responsible Party
Principal Investigator
Principal Investigator

ilker şengül

Principal Investigator

Izmir Katip Celebi University

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

Outcomes

Primary Outcomes

Pain/function

Time Frame: Baseline 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 Outcomes

  • Disease specific health-related quality of life(Baseline to 6 months follow-up)

Study Sites (1)

Loading locations...

Similar Trials