The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment

The primer aim of this study is to demonstrate the effect of instrument assisted soft tissue mobılızatıon on paın ,functıonality, joint range of motion patients with adhesive capsulitis

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis; ınstrument assısted Soft tıssue molılızatıon
• Intervention / Treatment: Device: soft tissue mobilization; Other: conventional physical therapy

Detailed Description

Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.

It is characterized by shoulder pain, decreased range of motion, and limitation of function. This affects the function of the entire upper extremity. Idiopathic adhesive capsulitis usually involves the non-dominant upper extremity, with bilateral involvement in 40-50% of cases. It is more common in women between the ages of 40 and 60. The incidence of adhesive capsulitis among the population is between 3% and 5%. It has been reported with up to 20% higher incidence in the diabetic population. It is also associated with other pathological disorders such as thyroid dysfunction, coronary artery disease and cerebrovascular disease. Although the pathology is self-limiting, long-term symptoms develop in approximately 20% to 50% of cases.

Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.

1. The painful phase lasts less than three months and presents with shoulder pain at night when glenohumeral movement is preserved.
2. The freezing process lasts three to nine months and is manifested by severe pain and stiffness in the glenohumeral joint.
3. The frozen shoulder process lasts nine to fourteen months and is eventually characterized by loss of motion and pain in all directions.
4. The resolution phase lasts for fifteen to twenty-four months and is characterized by persistent stiffness, minimal pain, and delayed improvement in shoulder motion.

Abnormal shoulder kinematics develops in response to the lack of extensibility of the capsule with the change in motor patterns in the central nervous system. Increased thoracic kyphosis can be seen as postural deviations. However, fibrotic changes are also seen in the periarticular connective tissue and trigger points. This presents as a higher level of disability with painful shoulder. Physiotherapy is the mainstay of treatment for patients with adhesive capsulitis. Joint mobilization has a proven role in conjunction with Codman's exercises. Transcutaneous Electrical Nerve Stimulation (TENS), Diathermy is used in the treatment to reduce pain. Instrument Assisted Soft Tissue Mobilization (IASTM) is a soft tissue mobilization method that works by generating localized inflammation and facilitates collagen synthesis and realignment. In fact, when IASTM is given to soft tissues with appropriate pressure, localized inflammation occurs with microvascular bleeding. This will increase blood flow to the injured area along with the recruitment of more fibroblasts. With the removal of scar tissues and adhesions, healing will be supported by the organization of collagen of fibroblasts. The fibronectin induced by IASTM is required for tissue repair. A localized force will be transmitted through an instrument to the affected tissues to leave a scar.

IASTM has become increasingly popular as a tool for the rehabilitation of sports injuries. It has been proven to be successful in a short time in reducing pain and increasing mobility after sports injuries. There are studies showing an increase in ROM after a single application of this technique.

It is known that it takes a long time to relieve pain and achieve a good improvement in ROM in adhesive capsulitis. This affects their quality of life and creates the need for treatment options that provide a shorter recovery time. Various conservative protocols are followed with physical therapy as the main treatment in adhesive capsulitis. Few studies have used IASTM as a treatment to evaluate its effect on adhesive capsulitis.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • City Center
    • Kırşehir, City Center, Turkey, 40100
      • Kırşehir Ahi Evran University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 1.Male and Female patients aged 20-60 years 2.Diagnosed with adhesive capsulitis 2. Loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.

3. consent to participate

Exclusion Criteria:

• 1. Injury to the upper extremity in the last 6 months 2. Shoulder injection in the last 6 months 3. Existing open wound in the upper extremity area 4. Previous upper extremity surgery 5. Being hypersensitive 6. Having a generalized infection 7. Having uncontrolled hypertension 8. Inability to cooperate; 9. The patient's unwillingness to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: soft tissue mobilization+conventional physical therapy; Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area soft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods.	Device: soft tissue mobilization; soft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods.; Other: conventional physical therapy; Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area
Placebo Comparator: conventional physical therapy; Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area.	Other: conventional physical therapy; Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.	baseline
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.	2. week (in the middle of treatment)
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.	4. week (at the end of treatment)
The Shoulder Pain and Disability Index (SPADI)	SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.	baseline
The Shoulder Pain and Disability Index (SPADI)	SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.	2. week (in the middle of treatment)
The Shoulder Pain and Disability Index (SPADI)	SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.	4. week (at the end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
joint range of motion	measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.	baseline
joint range of motion	measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.	2. week (in the middle of treatment)
joint range of motion	measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.	4. week (at the end of treatment)

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Basak Cigdem Karacay, Assoc. Prof, Kirsehir Ahi Evran Universitesi

Publications and helpful links

General Publications

• Aggarwal A, Saxena K, Palekar TJ, Rathi M. Instrument assisted soft tissue mobilization in adhesive capsulitis: A randomized clinical trial. J Bodyw Mov Ther. 2021 Apr;26:435-442. doi: 10.1016/j.jbmt.2020.12.039. Epub 2020 Dec 31.
• Laudner K, Compton BD, McLoda TA, Walters CM. Acute effects of instrument assisted soft tissue mobilization for improving posterior shoulder range of motion in collegiate baseball players. Int J Sports Phys Ther. 2014 Feb;9(1):1-7.
• Hussey MJ, Boron-Magulick AE, Valovich McLeod TC, Welch Bacon CE. The Comparison of Instrument-Assisted Soft Tissue Mobilization and Self-Stretch Measures to Increase Shoulder Range of Motion in Overhead Athletes: A Critically Appraised Topic. J Sport Rehabil. 2018 Jul 1;27(4):385-389. doi: 10.1123/jsr.2016-0213. Epub 2018 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: adhesıve capsulıtis; ınstrument assısted soft tıssue molılızatıon
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: E-77504701-604.-02.

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