Clinical trial NCT05266339: Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Official title: Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rotator Cuff Tears
Pain, Shoulder
Surgery
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.

Detailed description: Fifty voluntary patients who underwent arthroscopic rotator cuff repair, aged between 35-64 years will be randomly divided into two groups: Cross-education group and standard rehabilitation group. Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline, at the end of the 8-week intervention and 1-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status will be evaluated by Constant-Murley Score (CMS) and American Shoulder and Elbow Surgeons (ASES) Score. Health-related quality of life will be assessed with Short Form-12 (SF-12). The Global Rating of Change will be used to evaluate patient satisfaction.

Eligibility criteria: Inclusion Criteria:

Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish

Exclusion Criteria:

Revision surgery or previous shoulder surgery Having undergone subscapularis tendon repair in addition to arthroscopic rotator cuff repair Having scoliosis surgery or a health problem that will cause limitation in spinal mobility Restriction of movement or absence of limb in the opposite upper extremity Having frozen shoulder Presence of glenohumeral instability Having been diagnosed with thoracic outlet syndrome Presence of upper extremity fracture or tumor Having been diagnosed with cervical radiculopathy Having been diagnosed with any malignant condition, systemic, neurological or rheumatological disease Having a skin disease or hearing-vision problem that will affect the evaluation process

Primary outcomes:
measure: Constant-Murley Score
timeFrame: Baseline
Secondary outcomes:
measure: Constant-Murley Score
timeFrame: At the end of 8-week intervention
measure: Constant-Murley Score
timeFrame: 1-month follow-up after intervention
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: At the end of 8-week intervention
measure: Visual Analogue Scale
timeFrame: 1-month follow-up after intervention
measure: Active Range of Motion Assessment
timeFrame: Baseline
measure: Active Range of Motion Assessment
timeFrame: At the end of the 8-week intervention
measure: Active Range of Motion Assessment
timeFrame: 1-month follow-up after intervention
measure: Muscle Strength
timeFrame: At the end of the 8-week intervention
measure: Muscle Strength
timeFrame: 1-month follow-up after intervention
measure: American Shoulder and Elbow Surgeons Shoulder Score
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeons Shoulder Score
timeFrame: At the end of the 8-week intervention
measure: American Shoulder and Elbow Surgeons Shoulder Score
timeFrame: 1-month follow-up after intervention
measure: Short Form-12
timeFrame: Baseline
measure: Short Form-12
timeFrame: At the end of the 8-week intervention
measure: Short Form-12
timeFrame: 1-month follow-up after intervention
measure: Global Rating of Change
timeFrame: At the end of the 8-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: