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

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT05993000
Collaborator
(none)
40
1
4
24.5
1.6

Study Details

Study Description

Brief Summary

There are many methods used for treating frozen shoulder, but it's still unclear which one is the most effective even in today's world. Frequency music has recently started being used, especially for reducing anxiety and pain in intensive care patients. In our study, we aimed to investigate whether frequency music has a positive impact on shoulder pain and the quality of life of patients.

Condition or Disease Intervention/Treatment Phase
  • Other: 432 Hertz frequency music
  • Other: TENS
  • Other: Mobilization
  • Other: Exercises
  • Other: Hotpack
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients
Actual Study Start Date :
May 29, 2021
Actual Primary Completion Date :
Apr 26, 2022
Actual Study Completion Date :
Jun 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. VAS(Visual Analog Scale) [baseline and 6 weeks]

    The Visual Analog Scale (VAS) is a psychometric response scale used to measure subjective characteristics or attitudes, and it has been utilized to assess the pain levels of participants.

  2. Goniometer [baseline and 6 weeks]

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

  3. DASH(Disabilities of the Arm, Shoulder, and Hand) [baseline and 6 weeks]

    I used this scale to evaluate the participants' upper extremity functions.

  4. 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.

  5. SF-36(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."

Secondary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ondokuz Mayıs University Samsun Turkey 55500

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SELMA İŞLER, Physiotherapist, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT05993000
Other Study ID Numbers:
  • NEHIR55
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SELMA İŞLER, Physiotherapist, Ondokuz Mayıs University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023