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

NCT05678140 | Completed

• 1 other identifier: E-77504701-604.-02.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Adhesive Capsulitis; ınstrument assısted Soft tıssue molılızatıon

Keywords

adhesıve capsulıtis; ınstrument assısted soft tıssue molılızatıon

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• joint range of motion

  baseline

• joint range of motion

  2. week (in the middle of treatment)

• joint range of motion

  4. week (at the end of treatment)

Study Arms (2)

soft tissue mobilization+conventional physical therapy

EXPERIMENTAL

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; Other: conventional physical therapy

conventional physical therapy

PLACEBO COMPARATOR

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

Interventions

soft tissue mobilization DEVICE

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.

soft tissue mobilization+conventional physical therapy

conventional physical therapy OTHER

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

conventional physical therapy; soft tissue mobilization+conventional physical therapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• \. consent to participate

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33992280 RESULT

• 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.

  PMID: 24567849 RESULT

• 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.

  PMID: 28253058 RESULT

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Basak Cigdem Karacay, Assoc. Prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: randomızed controlled trıal

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: April 20, 2022
• Primary Completion: August 20, 2023
• Study Completion: September 20, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)