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

Not Applicable

Completed

• Conditions: Exercise; 432 Hertz Frequency Music; Manual Therapy; Frozen Shoulder
• Interventions: Other: 432 Hertz frequency music; Other: TENS; Other: Mobilization; Other: Hotpack; Other: Exercises

• Registration Number: NCT05993000
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2021-05-29
• Primary Completion: 2022-04-26
• Study Completion: 2023-06-15
• Study First Submitted: 2023-07-30
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup 2 ( music + exercise)	432 Hertz frequency music	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.
Grup 1(Music + mobilization + exercise was applied)	432 Hertz frequency music	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.
Grup 1(Music + mobilization + exercise was applied)	Mobilization	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.
Grup 2 ( music + exercise)	Hotpack	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.
Grup 1(Music + mobilization + exercise was applied)	TENS	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.
Grup 1(Music + mobilization + exercise was applied)	Exercises	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.
Grup 1(Music + mobilization + exercise was applied)	Hotpack	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.
Grup 3 (mobilization + exercise)	TENS	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.
Grup 3 (mobilization + exercise)	Exercises	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.
Grup 4 (exercise)	Hotpack	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.
Grup 2 ( music + exercise)	TENS	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.
Grup 2 ( music + exercise)	Exercises	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.
Grup 3 (mobilization + exercise)	Mobilization	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.
Grup 3 (mobilization + exercise)	Hotpack	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.
Grup 4 (exercise)	TENS	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.
Grup 4 (exercise)	Exercises	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.

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand	baseline and 6 weeks	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.
Visual Analog Scale	baseline and 6 weeks	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").
Modified Constant Score	baseline and 6 weeks	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.
Goniometer	baseline and 6 weeks	A goniometer was used to measure the participants' shoulder range of motion.
36-Item Short Form Health Survey	baseline and 6 weeks	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

Name	Time	Method
BMI(Basal Mass Index)	baseline and 6 weeks	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)

Trial Locations

Locations (1)

Ondokuz Mayıs University; 🇹🇷 Samsun, Turkey