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

NCT05993000 | Completed

• 1 other identifier: NEHIR55
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Frozen Shoulder; 432 Hertz Frequency Music; Manual Therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• BMI(Basal Mass Index)

  baseline and 6 weeks

Study Arms (4)

Grup 1(Music + mobilization + exercise was applied)

EXPERIMENTAL

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; Other: TENS; Other: Mobilization; Other: Exercises; Other: Hotpack

Grup 2 ( music + exercise)

EXPERIMENTAL

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; Other: TENS; Other: Exercises; Other: Hotpack

Grup 3 (mobilization + exercise)

ACTIVE COMPARATOR

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; Other: Mobilization; Other: Exercises; Other: Hotpack

Grup 4 (exercise)

ACTIVE COMPARATOR

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; Other: Exercises; Other: Hotpack

Interventions

432 Hertz frequency music OTHER

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

Grup 1(Music + mobilization + exercise was applied); Grup 2 ( music + exercise)

TENS 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.

Grup 1(Music + mobilization + exercise was applied); Grup 2 ( music + exercise); Grup 3 (mobilization + exercise); Grup 4 (exercise)

Mobilization 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.

Grup 1(Music + mobilization + exercise was applied); Grup 3 (mobilization + exercise)

Exercises 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.

Grup 1(Music + mobilization + exercise was applied); Grup 2 ( music + exercise); Grup 3 (mobilization + exercise); Grup 4 (exercise)

Hotpack OTHER

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

Grup 1(Music + mobilization + exercise was applied); Grup 2 ( music + exercise); Grup 3 (mobilization + exercise); Grup 4 (exercise)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• have shoulder girdle motor control deficits associated with neurological disorders.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• SELMA İŞLER, Phd

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Seydi Ahmet Ağaoğlu, Prof.

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 15, 2023
• Study Start: May 29, 2021
• Primary Completion: April 26, 2022
• Study Completion: June 15, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 years
• Access Criteria: Researchers at universities

Locations

TU (1)