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Fascial Release After Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fascial mobilization group
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karabuk University, Physiotherapy and Rehabilitation Application and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fascial mobilization group

Control Group

Arm Description

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.

The control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks.

Outcomes

Primary Outcome Measures

Pain severity
Visuel analog scale will be used to evaluate individuals' shoulder pain level.

Secondary Outcome Measures

Range of motion
Joint range of motion will be assessed using a universal goniometer
Kinesiophobia
The Tampa Kinesiophobia Scale (TSK) will be used to measure individuals' fear of movement/reinjury.
Functional level
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate functional disability.
Activities of Daily Living
The Disabilities of the Arm, Shoulder and Hand Scale will be used to evaluate acitivities of daily living.

Full Information

First Posted
October 12, 2023
Last Updated
October 12, 2023
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT06088667
Brief Title
Fascial Release After Arthroscopic Rotator Cuff Repair
Official Title
The Effect of Fascial Release on Pain, Range of Motion and Functionality After Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be 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. 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, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascial mobilization group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Fascial mobilization group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain severity
Description
Visuel analog scale will be used to evaluate individuals' shoulder pain level.
Time Frame
baseline and 4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Range of motion
Description
Joint range of motion will be assessed using a universal goniometer
Time Frame
baseline and 4 weeks post-intervention
Title
Kinesiophobia
Description
The Tampa Kinesiophobia Scale (TSK) will be used to measure individuals' fear of movement/reinjury.
Time Frame
baseline and 4 weeks post-intervention
Title
Functional level
Description
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate functional disability.
Time Frame
baseline and 4 weeks post-intervention
Title
Activities of Daily Living
Description
The Disabilities of the Arm, Shoulder and Hand Scale will be used to evaluate acitivities of daily living.
Time Frame
baseline and 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musa Güneş, MsC
Phone
05315132482
Email
musagunes@karabuk.edu.tr
Facility Information:
Facility Name
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
City
Karabük
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Musa Güneş, MsC
Phone
+905315132482
Email
musagunes@karabuk.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22089284
Citation
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.
Results Reference
background
PubMed Identifier
28400883
Citation
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.
Results Reference
background
PubMed Identifier
35397305
Citation
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.
Results Reference
result

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Fascial Release After Arthroscopic Rotator Cuff Repair

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