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Completed

NCT Number: NCT05993000

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

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.

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Key information

Conditions

Frozen Shoulder 432 Hertz Frequency Music Behavior Bursitis Exercise Joint Diseases Manual Therapy Motor Activity Musculoskeletal Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, 55500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

432 Hertz frequency music

Other

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

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.

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.

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.

Hotpack

Other

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

Primary outcomes

  1. Goniometer

    Time frame: baseline and 6 weeks

    A goniometer was used to measure the participants' shoulder range of motion.

  2. Visual Analog Scale

    Time frame: 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").

  3. Disabilities of the Arm, Shoulder, and Hand

    Time frame: 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.

  4. Modified Constant Score

    Time frame: 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.

  5. 36-Item Short Form Health Survey

    Time frame: 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 outcomes

  1. BMI(Basal Mass Index)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 15, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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