Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial

Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Frozen Shoulder; Manual Therapy; 432 Hertz Frequency Music
• Intervention / Treatment: Other: 432 Hertz frequency music; Other: TENS; Other: Mobilization; Other: Exercises; Other: Hotpack

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55500
    • Ondokuz Mayıs University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grup 1(Music + mobilization + exercise was applied); 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.	Other: 432 Hertz frequency music; 432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.; Other: TENS; 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.; Other: Mobilization; 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.; Other: Exercises; 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.; Other: Hotpack; Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
Experimental: Grup 2 ( music + exercise); 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.	Other: 432 Hertz frequency music; 432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.; Other: TENS; 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.; Other: Exercises; 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.; Other: Hotpack; Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
Active Comparator: Grup 3 (mobilization + exercise); 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.	Other: TENS; 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.; Other: Mobilization; 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.; Other: Exercises; 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.; Other: Hotpack; Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
Active Comparator: Grup 4 (exercise); 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.	Other: TENS; 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.; Other: Exercises; 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.; Other: Hotpack; Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometer	A goniometer was used to measure the participants' shoulder range of motion.	baseline and 6 weeks
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").	baseline and 6 weeks
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.	baseline and 6 weeks
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.	baseline and 6 weeks
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.	baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: SELMA İŞLER, Phd, Ondokuz Mayıs University; Study Director: Seydi Ahmet Ağaoğlu, Prof., Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2021
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Manual Therapy; Frozen Shoulder; 432 Hertz Frequency Music
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: NEHIR55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No