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

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low-intensity ESWT Group
Low-intensity laser Group
Conventional Control Group
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Rehabilitation, extracorporeal shock wave therapy, low-level laser therapy, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırşehir Ahi Evran Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Low-intensity ESWT Group

Low-intensity laser Group

Conventional Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales

Full Information

First Posted
December 13, 2022
Last Updated
August 2, 2023
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05689593
Brief Title
Comparison of Low-intensity Extracorporeal Shockwave Therapy and Low-intensity Laser Effects in Adhesive Capsulitis
Official Title
Comparison of the Efficiency of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Laser Therapy in Adhesive Capsulitis Treatment: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Rehabilitation, extracorporeal shock wave therapy, low-level laser therapy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups with a conventional therapy control group
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-intensity ESWT Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Low-intensity laser Group
Arm Type
Active Comparator
Arm Description
low intensity laser will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises
Arm Title
Conventional Control Group
Arm Type
Other
Arm Description
patients will receive a conventional therapy program consisting of hotpack and exercises
Intervention Type
Other
Intervention Name(s)
Low-intensity ESWT Group
Intervention Description
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
Intervention Name(s)
Low-intensity laser Group
Intervention Description
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
Intervention Name(s)
Conventional Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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
Time Frame
0. week
Title
Visual analogue scale (VAS)
Description
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
Time Frame
3. week
Title
Visual analogue scale (VAS)
Description
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
Time Frame
12. week
Title
CONSTANT (MURLEY) SCORE (CS)
Description
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
Time Frame
0. week
Title
CONSTANT (MURLEY) SCORE (CS)
Description
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
Time Frame
3. week
Title
CONSTANT (MURLEY) SCORE (CS)
Description
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
Time Frame
12.week
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Time Frame
0. week
Title
Pittsburgh Sleep Quality Index
Description
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Time Frame
3. week
Title
Pittsburgh Sleep Quality Index
Description
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Time Frame
12. week
Title
The Short Form Health Survey (SF-36)
Description
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Time Frame
0. week
Title
The Short Form Health Survey (SF-36)
Description
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Time Frame
3. week
Title
The Short Form Health Survey (SF-36)
Description
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Time Frame
12. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ismail Ceylan, PhD
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırşehir Ahi Evran Üniversitesi
City
Kırşehir
State/Province
Central Anatolia
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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