Clinical trial NCT05358730: Effects of IASTM in the Treatment of Adhesive Capsulitis
Official title: Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients with Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Shoulder
Adhesion; Shoulder
Myofacial Pain
Keywords: Adhesive capsulitis
Function
Pain
Exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Istanbul Aydın University
First posted: 2022-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.

Detailed description: Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.

Eligibility criteria: Inclusion Criteria:

* Aged between 30 and 65 years;
* Duration of complaint of more than three months
* ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions

Exclusion Criteria:

* Having cervical radiculopathy
* Thoracic outlet syndrome
* Rheumatological disorders
* Fractures or tumors of either upper extremity
* Corticosteroid injections in the affected shoulder within the previous 4 weeks

Primary outcomes:
measure: Upper extremity function
timeFrame: Baseline
Secondary outcomes:
measure: Upper extremity function
timeFrame: At the end of the 3-week intervention
measure: Upper extremity function
timeFrame: At the end of the 6-week intervention
measure: The severity of pain
timeFrame: Baseline
measure: The severity of pain
timeFrame: At the end of the 3-week intervention
measure: The severity of pain
timeFrame: At the end of the 6-week intervention
measure: Functional level of shoulder
timeFrame: Baseline
measure: Functional level of shoulder
timeFrame: At the end of the 3-week intervention
measure: Functional level of shoulder
timeFrame: At the end of the 6-week intervention
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: At the end of the 3-week intervention
measure: Range of motion
timeFrame: At the end of the 6-week intervention
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: At the end of the 3-week intervention
measure: Health-related quality of life
timeFrame: At the end of the 6-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: