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

NCT05689593 | Completed

• 1 other identifier: AEU-FTR-FE-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis

Keywords

Rehabilitation; extracorporeal shock wave therapy; low-level laser therapy; pain

Outcome Measures

Primary Outcomes (6)

• Visual analogue scale (VAS)

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity

  0. week

• Visual analogue scale (VAS)

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity

  3. week

• Visual analogue scale (VAS)

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity

  12. week

• CONSTANT (MURLEY) SCORE (CS)

  The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function

  0. week

• CONSTANT (MURLEY) SCORE (CS)

  The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function

  3. week

• CONSTANT (MURLEY) SCORE (CS)

  The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function

  12.week

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index

  0. week

• Pittsburgh Sleep Quality Index

  3. week

• Pittsburgh Sleep Quality Index

  12. week

• The Short Form Health Survey (SF-36)

  0. week

• The Short Form Health Survey (SF-36)

  3. week

Study Arms (3)

Low-intensity ESWT Group

ACTIVE COMPARATOR

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

Other: Low-intensity ESWT Group; Other: Conventional Control Group

Low-intensity laser Group

ACTIVE COMPARATOR

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

Other: Low-intensity laser Group; Other: Conventional Control Group

Conventional Control Group

OTHER

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

Other: Conventional Control Group

Interventions

Low-intensity ESWT Group 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)

Low-intensity ESWT Group

Low-intensity laser Group 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.

Low-intensity laser Group

Conventional Control Group 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; Low-intensity ESWT Group; Low-intensity laser Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Central Anatolia, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ismail Ceylan, PhD

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of hand therapy clinic. PhD.

Model Details: Three groups with a conventional therapy control group

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 19, 2023
• Study Start: January 21, 2023
• Primary Completion: May 2, 2023
• Study Completion: August 2, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)