- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088667
Fascial Release After Arthroscopic Rotator Cuff Repair
The Effect of Fascial Release on Pain, Range of Motion and Functionality After Arthroscopic Rotator Cuff Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rotator cuff (RC) rupture causes shoulder pain, muscle weakness, and decreased shoulder range of motion (ROM). Additionally, fear of movement develops due to shoulder pain, affecting ROM and function. Treatment of RC rupture is initially conservative. In cases where conservative treatment is inadequate, surgical option is preferred. Open, mini-open and arthroscopic repair can be used in surgery. In recent years, arthroscopic repair has been mostly preferred because it causes less pain than other surgical options, has a shorter hospital stay, and does not cause complications. A postoperative rehabilitation program is a crucial component of surgical success. The aim of this program is to reduce pain, increase ROM, and improve patients' functional level and activities of daily living. The postoperative rehabilitation program includes electrophysical agents, manual therapy and exercise.Surgery-related inflammation may restrict fascial tissue. Inflammation changes the mechanical properties of connective tissue, causing adhesions and eventually leading to stiffness. Thus, the slip between fascial surfaces decreases and, accordingly, ROM and function decrease.
Instrument Assisted Soft Tissue Mobilization (IASTM) is used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. However, it is noteworthy that there is a lack of studies examining the long-term effectiveness of fascial mobilization in shoulder pathologies. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, range of motion, fear of movement, and daily living activities in patients 4 weeks after rotator cuff arthroscopic surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karabük, Turkey
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 18 years old
- 4 weeks have passed since arthroscopic rotator cuff repair
Exclusion Criteria:
- cervical discopathy,
- shoulder osteoarthritis
- fracture or tumor of the upper extremity,
- adhesive capsulitis,
- shoulder instability,
- thoracic outlet syndrome and
- patients with neurological or mental problems.
- Non-voluntary patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fascial mobilization group
In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments.
|
In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks.
|
|
Experimental: Control Group
The control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks.
|
In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity
Time Frame: baseline and 4 weeks post-intervention
|
Visuel analog scale will be used to evaluate individuals' shoulder pain level.
|
baseline and 4 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: baseline and 4 weeks post-intervention
|
Joint range of motion will be assessed using a universal goniometer
|
baseline and 4 weeks post-intervention
|
|
Kinesiophobia
Time Frame: baseline and 4 weeks post-intervention
|
The Tampa Kinesiophobia Scale (TSK) will be used to measure individuals' fear of movement/reinjury.
|
baseline and 4 weeks post-intervention
|
|
Functional level
Time Frame: baseline and 4 weeks post-intervention
|
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate functional disability.
|
baseline and 4 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pegreffi F, Paladini P, Campi F, Porcellini G. Conservative management of rotator cuff tear. Sports Med Arthrosc Rev. 2011 Dec;19(4):348-53. doi: 10.1097/JSA.0b013e3182148dc6.
- Nikolaidou O, Migkou S, Karampalis C. Rehabilitation after Rotator Cuff Repair. Open Orthop J. 2017 Feb 28;11:154-162. doi: 10.2174/1874325001711010154. eCollection 2017.
- Coban T, Demirdel E, Yildirim NU, Deveci A. The investigation of acute effects of fascial release technique in patients with arthroscopic rotator cuff repair: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101573. doi: 10.1016/j.ctcp.2022.101573. Epub 2022 Mar 21.
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
- Karabuk University 78
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.