Clinical trial NCT05176028: Acute Effects of Fascial Release Technique in Patients With Rotator Cuff Repair
Official title: The Investigation of Acute Effects of Fascia Technique in Patients With Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Rotator Cuff Repair
Keywords: Pain
Arthroscopic Rotator Cuff Repair
Range of Motion
Fascial Release Technique
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hotpack, interferential current and exercise program were applied to the control group (n=15), the fascia technique was applied to the treatment group (n=15) in addition to the control group program for 2 weeks with 2 sessions per week.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain severity
timeFrame: 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.
measure: Pain severity
timeFrame: 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 outcomes:
measure: Range of motion
timeFrame: Before treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
measure: Range of motion
timeFrame: After treatment, the active flexion, abduction, internal and external ROM of the individuals was evaluated using a universal goniometer in the supine position.
Other outcomes:
measure: Functional level
timeFrame: 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.
measure: Fear of movement
timeFrame: 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.
measure: Patient satisfaction
timeFrame: 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.
measure: Functional level
timeFrame: 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.
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
state: Dumlupınar, Çubuk
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Ertuğrul Demirdel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.