NCT05176028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 3, 2021

Last Update Submit

December 15, 2021

Conditions

Keywords

PainArthroscopic Rotator Cuff RepairRange of MotionFascial Release Technique

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Range of motion

    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

    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 (4)

  • Functional level

    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

    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

    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.

  • +1 more other outcomes

Study Arms (2)

Control group

EXPERIMENTAL

conventional physiotherapy

Other: conventional physiotherapy

Intervention group

EXPERIMENTAL

conventional physiotherapy and fascial release

Other: conventional physiotherapyOther: fascial release

Interventions

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.

Control groupIntervention group

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 18 years old
  • patients undergone arthroscopic rotator cuff repair after least six weeks surgery

You may not qualify if:

  • cervical discopathy
  • shoulder osteoarthritis
  • fracture or tumor of upper extremity
  • adhesive capsulitis
  • shoulder instability
  • thoracic outlet syndrome
  • neurologic or mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Dumlupınar, Çubuk, 06760, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29399735BACKGROUND
  • 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.

    PMID: 22196432BACKGROUND
  • 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.

    PMID: 21147420BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ertuğrul Demirdel, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 3, 2021

First Posted

January 4, 2022

Study Start

January 3, 2018

Primary Completion

July 9, 2018

Study Completion

July 23, 2018

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations