Back to resultsAssessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
Primary Purpose
Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
432 Hertz frequency music
TENS
Mobilization
Exercises
Hotpack
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
Eligibility Criteria
Inclusion Criteria: idiopathic or primary adhesive capsulitis5,20,32, a diagnosis of stage 2-3, unilateral condition, age between 30 to 65 years, normal findings on radiographs within the previous 12 months, no previous shoulder surgeries to the affected shoulder, no previous manipulations under anesthesia of the affected shoulder, passive joint movements limited to 50-75% of the normal range of motion of the joint, - and no hearing loss. Exclusion Criteria: have shoulder girdle motor control deficits associated with neurological disorders.
Sites / Locations
- Ondokuz Mayıs University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Grup 1(Music + mobilization + exercise was applied)
Grup 2 ( music + exercise)
Grup 3 (mobilization + exercise)
Grup 4 (exercise)
Arm Description
In this group, hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) were applied to the patients simultaneously, while they were listening to 432 hertz frequency music through headphones. Subsequently, shoulder mobilization was applied in appropriate positions. The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
In this group, hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) were applied to the patients simultaneously, while they were listening to 432 hertz frequency music through headphones. The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
After applying hot packs and TENS(Transcutaneous Electrical Nerve Stimulation) to the patients, shoulder mobilization was performed in suitable positions.The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
After the application of hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) to the patients, the physiotherapist administered specific exercises during the session. Additionally, customized exercises were prescribed as a home program for the patients to continue their rehabilitation outside of the clinic setting.
Outcomes
Primary Outcome Measures
Goniometer
A goniometer was used to measure the participants' shoulder range of motion.
Visual Analog Scale
The Visual Analog Scale is a psychometric response scale used to measure subjective characteristics or attitudes, and it has been utilized to assess the pain levels of participants.10-cm visual analog scale, ranging from 0 ("no pain") to 10 ("the worst imaginable pain").
Disabilities of the Arm, Shoulder, and Hand
I used this scale to evaluate the participants' upper extremity functions.The questionnaire consists of 30 items that cover various activities related to daily living, work, and recreational activities that involve the use of the upper extremities. Participants rate their ability to perform each activity and the severity of their symptoms on a scale from 1 to 5, where 1 represents "no difficulty" or "no symptoms" and 5 represents "unable to do" or "extremely severe symptoms."A high score means that the patient's condition is poor.
Modified Constant Score
The questionnaire used to measure muscle strength was applied because the participants had shoulder joint range of motion less than 90 degrees before treatment.The Modified Constant Score typically evaluates four main components:
Pain ( 0 being no pain and 15 being severe pain),Activities of Daily Living (20 points: This section assesses the patient's ability to perform various activities using the affected shoulder, such as combing hair, putting on a coat, and reaching behind the back), Strength ( The examiner rates the strength on a scale from 0 to 25), Range of Motion (40 points). The total Modified Constant Score is the sum of the points obtained in each of these four components, resulting in a maximum score of 100. Higher scores indicate better shoulder function and range of motion.
36-Item Short Form Health Survey
Anket used to assess the overall health status of the participants is the "36-Item Short Form Health Survey" or "SF-36.The SF-36 consists of 36 questions that cover eight health domains:
Physical Functioning, Role Limitations due to Physical Health Problems,Bodily Pain,General Health,Vitality, Social Functioning,Role Limitations due to Emotional Problems, Mental Health.
Each domain is assessed through multiple questions, and the responses are scored and transformed to create summary scores for each domain. These summary scores can range from 0 to 100, with higher scores indicating better health-related quality of life.
Secondary Outcome Measures
BMI(Basal Mass Index)
BMI is a measure that assesses the relationship between a participants weight and height. BMI is calculated using weight in kilograms and height in meters.
The formula for calculating BMI is as follows:
BMI = Weight (kg) / (Height)^2 (m^2)
Full Information
NCT ID
NCT05993000
First Posted
July 30, 2023
Last Updated
August 23, 2023
Sponsor
Ondokuz Mayıs University
1. Study Identification
Unique Protocol Identification Number
NCT05993000
Brief Title
Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
Official Title
Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2021 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to determine the effect of listening to music during the treatment of frozen shoulder on pain, normal range of motion, functional activity status and quality of life.Upon recruitment, the subjects were randomly assigned to one of four treatment groups: Group 1 received Music + Mobilization + Exercise, Group 2 received Music + Exercise, Group 3 received Mobilization + Exercise, and Group 4 received Exercise only.
Detailed Description
Forty individuals diagnosed with frozen shoulder were randomly allocated into four distinct treatment groups. Each participant received a total of eighteen treatment sessions, administered three days per week. Pain levels, range of motion of the shoulder joint, functional status, general health condition, and quality of life were measured and recorded for each participant both before and after the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy, Exercise
Keywords
Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grup 1(Music + mobilization + exercise was applied)
Arm Type
Experimental
Arm Description
In this group, hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) were applied to the patients simultaneously, while they were listening to 432 hertz frequency music through headphones. Subsequently, shoulder mobilization was applied in appropriate positions. The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
Arm Title
Grup 2 ( music + exercise)
Arm Type
Experimental
Arm Description
In this group, hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) were applied to the patients simultaneously, while they were listening to 432 hertz frequency music through headphones. The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
Arm Title
Grup 3 (mobilization + exercise)
Arm Type
Active Comparator
Arm Description
After applying hot packs and TENS(Transcutaneous Electrical Nerve Stimulation) to the patients, shoulder mobilization was performed in suitable positions.The exercises were conducted by the physiotherapist during the session and the manageable exercises were given to the patients as a home program.
Arm Title
Grup 4 (exercise)
Arm Type
Active Comparator
Arm Description
After the application of hot packs and TENS (Transcutaneous Electrical Nerve Stimulation) to the patients, the physiotherapist administered specific exercises during the session. Additionally, customized exercises were prescribed as a home program for the patients to continue their rehabilitation outside of the clinic setting.
Intervention Type
Other
Intervention Name(s)
432 Hertz frequency music
Intervention Description
432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
The TENS treatment was conducted using a double-channel TENS device equipped with four electrodes. The electrodes were placed around the painful area to ensure targeted stimulation. Each session lasted for 30 minutes, during which the TENS device operated at a high frequency range of 60-120 Hz. To achieve the desired analgesic effect, a short transition time of 20-120 microseconds was employed.
Intervention Type
Other
Intervention Name(s)
Mobilization
Intervention Description
Electrophysiological agents were administered to the affected shoulder joint area before initiating mobilization. The Cyriax mobilization techniques targeted the scapula, clavicular, and GH joints, considering their biomechanical interaction and the specific dysfunction of each patient.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
The combined utilization of exercises targeting the glenohumeral (GH) joint, scapulothoracic (ST) region, and stretching has demonstrated significant effectiveness in ameliorating range of motion and alleviating pain during the treatment of Frozen Shoulder (FS). These exercises were closely supervised and administered by the physiotherapist in each session. Furthermore, a home exercise program was provided to the patients, consisting of exercises for posture, thera band, and finger ladder. They were instructed to perform 10-15 repetitions of these exercises twice a day independently.
Intervention Type
Other
Intervention Name(s)
Hotpack
Intervention Description
Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
Primary Outcome Measure Information:
Title
Goniometer
Description
A goniometer was used to measure the participants' shoulder range of motion.
Time Frame
baseline and 6 weeks
Title
Visual Analog Scale
Description
The Visual Analog Scale is a psychometric response scale used to measure subjective characteristics or attitudes, and it has been utilized to assess the pain levels of participants.10-cm visual analog scale, ranging from 0 ("no pain") to 10 ("the worst imaginable pain").
Time Frame
baseline and 6 weeks
Title
Disabilities of the Arm, Shoulder, and Hand
Description
I used this scale to evaluate the participants' upper extremity functions.The questionnaire consists of 30 items that cover various activities related to daily living, work, and recreational activities that involve the use of the upper extremities. Participants rate their ability to perform each activity and the severity of their symptoms on a scale from 1 to 5, where 1 represents "no difficulty" or "no symptoms" and 5 represents "unable to do" or "extremely severe symptoms."A high score means that the patient's condition is poor.
Time Frame
baseline and 6 weeks
Title
Modified Constant Score
Description
The questionnaire used to measure muscle strength was applied because the participants had shoulder joint range of motion less than 90 degrees before treatment.The Modified Constant Score typically evaluates four main components:
Pain ( 0 being no pain and 15 being severe pain),Activities of Daily Living (20 points: This section assesses the patient's ability to perform various activities using the affected shoulder, such as combing hair, putting on a coat, and reaching behind the back), Strength ( The examiner rates the strength on a scale from 0 to 25), Range of Motion (40 points). The total Modified Constant Score is the sum of the points obtained in each of these four components, resulting in a maximum score of 100. Higher scores indicate better shoulder function and range of motion.
Time Frame
baseline and 6 weeks
Title
36-Item Short Form Health Survey
Description
Anket used to assess the overall health status of the participants is the "36-Item Short Form Health Survey" or "SF-36.The SF-36 consists of 36 questions that cover eight health domains:
Physical Functioning, Role Limitations due to Physical Health Problems,Bodily Pain,General Health,Vitality, Social Functioning,Role Limitations due to Emotional Problems, Mental Health.
Each domain is assessed through multiple questions, and the responses are scored and transformed to create summary scores for each domain. These summary scores can range from 0 to 100, with higher scores indicating better health-related quality of life.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
BMI(Basal Mass Index)
Description
BMI is a measure that assesses the relationship between a participants weight and height. BMI is calculated using weight in kilograms and height in meters.
The formula for calculating BMI is as follows:
BMI = Weight (kg) / (Height)^2 (m^2)
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
idiopathic or primary adhesive capsulitis5,20,32,
a diagnosis of stage 2-3,
unilateral condition,
age between 30 to 65 years,
normal findings on radiographs within the previous 12 months,
no previous shoulder surgeries to the affected shoulder,
no previous manipulations under anesthesia of the affected shoulder,
passive joint movements limited to 50-75% of the normal range of motion of the joint, - and no hearing loss.
Exclusion Criteria:
have shoulder girdle motor control deficits associated with neurological disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SELMA İŞLER, Phd
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seydi Ahmet Ağaoğlu, Prof.
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayıs University
City
Samsun
ZIP/Postal Code
55500
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Researchers at universities
Learn more about this trial
Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
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