- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05176028
Acute Effects of Fascial Release Technique in Patients With Rotator Cuff Repair
December 15, 2021 updated by: Tuğçe Çoban, Gazi University
The Investigation of Acute Effects of Fascia Technique in Patients With Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
This study was planned to investigate the acute effects of fascia technique on pain, range of motion, upper extremity functional level, and kinesiophobia in individuals with arthroscopic rotator cuff repair.Thirty volunteers with an arthroscopic rotator cuff repair were included to study.
The individuals were randomly divided into two groups.
While hot pack, interferential current and exercise program were applied to the classical physiotherapy group, the fascial release technique was applied to the treatment group in addition to the classical physiotherapy program for 2 weeks with 2 sessions per week.
Individuals were assessed for pain severity by using Visual Analog Scale, range of motion by goniometer, functional level by SPADI, kinesiophobia by Tampa Kinesiophobia Scale before and after treatment and satisfaction level by using Visual Analogue Scale after treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Rotator cuff (RC) rupture is cause of shoulder pain, muscle weakness, decrease of shoulder range of motion (ROM), and function.The initial treatment of RC rupture is conservative treatment.
The surgical option is preferred when conservative treatment is insufficient.
Open, mini-open, and arthroscopic repair may be used in surgery.
In the last years, mostly arthroscopic repair has preffered because of less pain, hospitalisation period, and complications than other surgical options.
Postoperative rehabilitation program is important component of surgical success.
The aim of this program is to decrease pain, increase ROM, and to improve function level and daily living activities of patients.Fascia is a unit connective tissue structure surrounding whole body and divided into three groups as visceral fascia, superficial fascia, and deep fascia.Fascial tissue is affected diversely due to several reasons like emotional state, injury, and surgical interventions.
Inflammation because of surgery may restricts fascial tissue.
Inflammation changes mechanical properties of connective tissue, cause adhesions, and finally leads to stiffness.
Thereby slidings between fascial surfaces diminish, and ROM and function decrease.
To release the restricted fascial tissue, several myofascial techniques are used.
One of these techniques is the fascial relase technique.
Myofascial techniques have effects on reducing pain, increasing ROM, and functional level.
As is known, there is no study in literature for investigating the effects of fascial relase technique on pain, ROM, and function in individuals with arthroscopic RC repair.
Therefore, this study was designed to investigate the acute effects of fascial release technique on pain, ROM, functional level, and kinesiophobia in patients with arthroscopic rotator cuff repair.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Dumlupınar, Çubuk
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Ankara, Dumlupınar, Çubuk, Turkey, 06760
- Ankara Yildirim Beyazit University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Minimum 18 years old
- patients undergone arthroscopic rotator cuff repair after least six weeks surgery
Exclusion Criteria:
- cervical discopathy
- shoulder osteoarthritis
- fracture or tumor of upper extremity
- adhesive capsulitis
- shoulder instability
- thoracic outlet syndrome
- neurologic or mental problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
conventional physiotherapy
|
For individuals of control group, hot pack applied for 20 minutes in the sitting position, Interferential Current was applied for the analgesic effect at a constant 100 Hz frequency on the anterior, posterior, superior and inferior part of the operated shoulder.
By increasing the current slowly, the dosage of the current was adjusted to such a degree that the patient could tolerate it.
|
|
Experimental: Intervention group
conventional physiotherapy and fascial release
|
For individuals of control group, hot pack applied for 20 minutes in the sitting position, Interferential Current was applied for the analgesic effect at a constant 100 Hz frequency on the anterior, posterior, superior and inferior part of the operated shoulder.
By increasing the current slowly, the dosage of the current was adjusted to such a degree that the patient could tolerate it.
Fascial release technique was applied to the patients in the treatment group besides the control group program.
The technique was applied to the cervical, thoracolumbar and upper extremity areas until tissue loosening and releasing were felt.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity
Time Frame: Before treatment, the severity of pain at rest, during activity and at night was evaluated using VAS. The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
Pain is an unpleasant sensation and emotional experience.
|
Before treatment, the severity of pain at rest, during activity and at night was evaluated using VAS. The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
|
Pain severity
Time Frame: After treatment, the severity of pain at rest, during activity and at night was evaluated using VAS. The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
Pain is an unpleasant sensation and emotional experience.
|
After treatment, the severity of pain at rest, during activity and at night was evaluated using VAS. The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: Before treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
|
Range of motion is the measurement of movement.
|
Before treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
|
|
Range of motion
Time Frame: After treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
|
Range of motion is the measurement of movement.
|
After treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional level
Time Frame: Before treatment, SPADI was used to evaluate the functional level consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
Functional level was assessed by Shoulder Pain and Disability Index (SPADI) before and after treatment.
|
Before treatment, SPADI was used to evaluate the functional level consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
|
Fear of movement
Time Frame: The scale consists of 17 questions which is about the injury or re-injury in work-related activities and fear-avoidance. A 4-point Likert system is used in the scale after treatment.
|
Fear of movement was evaluated by TAMPA Kinesiophobia Scale before and after treatment.
|
The scale consists of 17 questions which is about the injury or re-injury in work-related activities and fear-avoidance. A 4-point Likert system is used in the scale after treatment.
|
|
Patient satisfaction
Time Frame: To determine the level of satisfaction with the treatment they received, it was asked the patients to give a score between 0 (not at all satisfied) and 10 (very satisfied) using VAS after treatment.
|
Patient satisfaction after treatment was assessed by VAS.
|
To determine the level of satisfaction with the treatment they received, it was asked the patients to give a score between 0 (not at all satisfied) and 10 (very satisfied) using VAS after treatment.
|
|
Functional level
Time Frame: After treatment, SPADI was used to evaluate the functional level consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
Functional level was assessed by Shoulder Pain and Disability Index (SPADI) before and after treatment.
|
After treatment, SPADI was used to evaluate the functional level consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sgroi TA, Cilenti M. Rotator cuff repair: post-operative rehabilitation concepts. Curr Rev Musculoskelet Med. 2018 Mar;11(1):86-91. doi: 10.1007/s12178-018-9462-7.
- Simmonds N, Miller P, Gemmell H. A theoretical framework for the role of fascia in manual therapy. J Bodyw Mov Ther. 2012 Jan;16(1):83-93. doi: 10.1016/j.jbmt.2010.08.001. Epub 2010 Sep 27.
- Kain J, Martorello L, Swanson E, Sego S. Comparison of an indirect tri-planar myofascial release (MFR) technique and a hot pack for increasing range of motion. J Bodyw Mov Ther. 2011 Jan;15(1):63-7. doi: 10.1016/j.jbmt.2009.12.002. Epub 2010 Jan 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2018
Primary Completion (Actual)
July 9, 2018
Study Completion (Actual)
July 23, 2018
Study Registration Dates
First Submitted
December 3, 2021
First Submitted That Met QC Criteria
December 15, 2021
First Posted (Actual)
January 4, 2022
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
December 15, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- FON 2017/71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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