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

Primary Purpose

Adhesive Capsulitis, ınstrument assısted Soft tıssue molılızatıon

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
soft tissue mobilization
conventional physical therapy
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesıve capsulıtis, ınstrument assısted soft tıssue molılızatıon

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırşehir Ahi Evran University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

soft tissue mobilization+conventional physical therapy

conventional physical therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.

Full Information

First Posted
December 23, 2022
Last Updated
January 18, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05678140
Brief Title
The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
Official Title
The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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. The painful phase lasts less than three months and presents with shoulder pain at night when glenohumeral movement is preserved. The freezing process lasts three to nine months and is manifested by severe pain and stiffness in the glenohumeral joint. The frozen shoulder process lasts nine to fourteen months and is eventually characterized by loss of motion and pain in all directions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, ınstrument assısted Soft tıssue molılızatıon
Keywords
adhesıve capsulıtis, ınstrument assısted soft tıssue molılızatıon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomızed controlled trıal
Masking
Care ProviderInvestigator
Masking Description
The researcher will not know which treatment is applied to the patients. The physiotherapist who gives the treatment will not know the results of the research.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
soft tissue mobilization+conventional physical therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional physical therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
soft tissue mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
baseline
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
2. week (in the middle of treatment)
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
4. week (at the end of treatment)
Title
The Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
baseline
Title
The Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
2. week (in the middle of treatment)
Title
The Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
4. week (at the end of treatment)
Secondary Outcome Measure Information:
Title
joint range of motion
Description
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Time Frame
baseline
Title
joint range of motion
Description
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Time Frame
2. week (in the middle of treatment)
Title
joint range of motion
Description
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Time Frame
4. week (at the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Başak Çiğdem Karaçay, asst prof
Phone
054450494803
Ext
+90
Email
basak.cigdemkaracay@ahievran.edu.tr
Facility Information:
Facility Name
Kırşehir Ahi Evran University Faculty of Medicine
City
Kırşehir
State/Province
City Center
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Başak Çiğdem Karaçay, asıst prof
Phone
+9005445094803
Email
basak.cigdemkaracay@ahievran.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33992280
Citation
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.
Results Reference
result
PubMed Identifier
24567849
Citation
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.
Results Reference
result
PubMed Identifier
28253058
Citation
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.
Results Reference
result

Learn more about this trial

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

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