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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05176028
Other study ID # FON 2017/71
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2018
Est. completion date July 23, 2018

Study information

Verified date December 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 23, 2018
Est. primary completion date July 9, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
fascial release
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.

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University Ankara Dumlupinar, Çubuk

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Functional level 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.
Other Fear of movement 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.
Other Patient satisfaction 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.
Other Functional level 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.
Primary Pain severity 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.
Primary Pain severity 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 Range of motion 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.
Secondary Range of motion 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.
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