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

NCT ID: NCT05993000

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-29
• Study Completion Date: 2023-06-15

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.

Conditions

Frozen Shoulder; 432 Hertz Frequency Music; Manual Therapy; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

432 Hertz frequency music

Intervention Type: OTHER

432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.

TENS

Intervention Type: OTHER

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.

Mobilization

Intervention Type: OTHER

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.

Exercises

Intervention Type: OTHER

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.

Hotpack

Intervention Type: OTHER

Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

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.

Group Type: EXPERIMENTAL

432 Hertz frequency music

Intervention Type: OTHER

432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.

TENS

Intervention Type: OTHER

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.

Exercises

Intervention Type: OTHER

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.

Hotpack

Intervention Type: OTHER

Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

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.

Group Type: ACTIVE_COMPARATOR

TENS

Intervention Type: OTHER

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.

Mobilization

Intervention Type: OTHER

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.

Exercises

Intervention Type: OTHER

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.

Hotpack

Intervention Type: OTHER

Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

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.

Group Type: ACTIVE_COMPARATOR

TENS

Intervention Type: OTHER

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.

Exercises

Intervention Type: OTHER

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.

Hotpack

Intervention Type: OTHER

Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

Interventions

432 Hertz frequency music

432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Hotpack

Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

SELMA İŞLER

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SELMA İŞLER, Phd

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Seydi Ahmet Ağaoğlu, Prof.

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NEHIR55

Identifier Type: -

Identifier Source: org_study_id