Comparison of Low-intensity Extracorporeal Shockwave Therapy and Low-intensity Laser Effects in Adhesive Capsulitis

NCT ID: NCT05689593

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-21

Study Completion Date

2023-08-02

Brief Summary

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The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.

Detailed Description

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In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.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.

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

low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups with a conventional therapy control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method.) They will be divided into Group A (Low-intensity eswt, hot pack and exercise) and Group B (low intensity laser, hot pack and exercise) Group C (hot pack and exercise).

Outcome evaluations in the study will be carried out by a researcher who is blind to group allocation.

Study Groups

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Low-intensity ESWT Group

low intensity extracorporeal shock wave therapy will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises

Group Type ACTIVE_COMPARATOR

Low-intensity ESWT Group

Intervention Type OTHER

ESWT; With the MODUS ESWT system, the patient's shoulder will be in 80° passive abduction, the elbow will be in 90° flexion, and the forearm will be applied to 2 separate parts of the shoulder. The first application will be applied from front to back in the anterior shoulder joint and the upper limit of the treatment will be approximately 1 finger lateral to the coracoid process, the second application will be applied from the lateral scapula to the posterior shoulder joint (0.06 mJ/mm2, 1500 impulses, 1.5 bar).( Modus ESWT® RadialShockwaveTherapy)

Conventional Control Group

Intervention Type OTHER

Exercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist.

Low-intensity laser Group

low intensity laser will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises

Group Type ACTIVE_COMPARATOR

Low-intensity laser Group

Intervention Type OTHER

The laser will be made parallel to the joint line with the patient's arm, the arm will be in internal rotation at the posterior of the shoulder and the arm will be in external rotation at the anterior of the shoulder. The wavelength of 850 nm will be applied for 5 minutes in total 30 Joules.

Conventional Control Group

Intervention Type OTHER

Exercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist.

Conventional Control Group

patients will receive a conventional therapy program consisting of hotpack and exercises

Group Type OTHER

Conventional Control Group

Intervention Type OTHER

Exercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist.

Interventions

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Low-intensity ESWT Group

ESWT; With the MODUS ESWT system, the patient's shoulder will be in 80° passive abduction, the elbow will be in 90° flexion, and the forearm will be applied to 2 separate parts of the shoulder. The first application will be applied from front to back in the anterior shoulder joint and the upper limit of the treatment will be approximately 1 finger lateral to the coracoid process, the second application will be applied from the lateral scapula to the posterior shoulder joint (0.06 mJ/mm2, 1500 impulses, 1.5 bar).( Modus ESWT® RadialShockwaveTherapy)

Intervention Type OTHER

Low-intensity laser Group

The laser will be made parallel to the joint line with the patient's arm, the arm will be in internal rotation at the posterior of the shoulder and the arm will be in external rotation at the anterior of the shoulder. The wavelength of 850 nm will be applied for 5 minutes in total 30 Joules.

Intervention Type OTHER

Conventional Control Group

Exercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male and female patients who have received "adhesive capsulitis" by clinical and examination
* Patients with loss of range of motion in the capsular pattern (external rotation \> abduction \> internal rotation) will be included in the study.
* Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria

* Upper extremity injury in the last 6 months
* Shoulder injection in the last 6 months
* Existing open wound in the upper extremity area
* Prior upper extremity surgery
* The patient has a systemic infection
* Uncontrolled hypertension in the patient
* Inability of the patient to cooperate
* The patient's unwillingness to participate in the study
* The patient has a malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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İSMAİL CEYLAN

Head of hand therapy clinic. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ismail Ceylan, PhD

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Locations

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Kırşehir Ahi Evran Üniversitesi

Kırşehir, Central Anatolia, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AEU-FTR-FE-01

Identifier Type: -

Identifier Source: org_study_id

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