Frozen ShoulderNCT05993000
Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
A study testing 432 Hertz frequency music, TENS and Mobilization in people with Frozen Shoulder and 432 Hertz Frequency Music, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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 +… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
- What is being tested?
- 432 Hertz frequency music, TENS and Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- have shoulder girdle motor control deficits associated with neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients
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.
Read the 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
- Being tested
- 432 Hertz frequency music, TENS, Mobilization, Exercises, Hotpack
- Keywords
- Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
- Medical subject headings
- Bursitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
432 Hertz frequency musicOther
432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.
TENSOther
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.
MobilizationOther
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.
ExercisesOther
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.
HotpackOther
Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: TENS; Other: Exercises; Other: Hotpack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
A goniometer was used to measure the participants' shoulder range of motion.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 6 weeks
Secondary outcomes (1)
BMI(Basal Mass Index)
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)
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start29 May 2021
- Primary completion26 Apr 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELMA İŞLER, Ondokuz Mayıs University
- Investigators
- SELMA İŞLER, Phd, Principal investigator, Ondokuz Mayıs UniversitySeydi Ahmet Ağaoğlu, Prof., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993000
- Sponsor's protocol ID
- NEHIR55
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients
- ClinicalTrials.gov ID
- NCT05993000
- Acronym / sponsor ID
- NEHIR55
- Conditions
- Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy, Exercise
- Keywords
- Frozen Shoulder, 432 Hertz Frequency Music, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 29 May 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Grup 1(Music + mobilization + exercise was applied) | Experimental | Other: 432 Hertz frequency music, Other: TENS, Other: Mobilization, Other: Exercises, Other: HotpackIn 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) | Experimental | Other: 432 Hertz frequency music, Other: TENS, Other: Exercises, Other: HotpackIn 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) | Active comparator | Other: TENS, Other: Mobilization, Other: Exercises, Other: HotpackAfter 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) | Active comparator | Other: TENS, Other: Exercises, Other: HotpackAfter 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (1 listed)
- have shoulder girdle motor control deficits associated with neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 432 Hertz frequency music432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications. | Other | Grup 1(Music + mobilization + exercise was applied), Grup 2 ( music + exercise) |
| TENSThe 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 | Grup 1(Music + mobilization + exercise was applied), Grup 2 ( music + exercise), Grup 3 (mobilization + exercise), Grup 4 (exercise) |
| MobilizationElectrophysiological 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 | Grup 1(Music + mobilization + exercise was applied), Grup 3 (mobilization + exercise) |
| ExercisesThe 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 | Grup 1(Music + mobilization + exercise was applied), Grup 2 ( music + exercise), Grup 3 (mobilization + exercise), Grup 4 (exercise) |
| HotpackEach group of patients received a 20-minute hot pack application to the scapula and shoulder circumference. | Other | Grup 1(Music + mobilization + exercise was applied), Grup 2 ( music + exercise), Grup 3 (mobilization + exercise), Grup 4 (exercise) |
Primary outcome
Goniometer
Time frame: baseline and 6 weeks
A goniometer was used to measure the participants' shoulder range of motion.
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").
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.
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.
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.
1 secondary outcome
BMI(Basal Mass Index)
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SELMA İŞLER, Phd principal investigator
Ondokuz Mayıs University
Seydi Ahmet Ağaoğlu, Prof. study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 432 Hertz frequency music, TENS and Mobilization in people with Frozen Shoulder and 432 Hertz Frequency Music, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometer (time frame: baseline and 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.