High Intensity LaserlasershoulderNCT06732570
Effect of High Intensity Laser on Shoulder Impingement.
A study testing high intensity laser, manual therapy and exercise therapy in people with High Intensity Laser and Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Treatment for shoulder impingement is conservative initially, Rehabilitation programs generally consist of exercise therapy and manual therapy that provide relief from symptoms of impingement. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- High Intensity Laser, Shoulder Impingement Syndrome, Shoulder Pain
- What is being tested?
- high intensity laser, manual therapy and exercise therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age was ranged between 12-18 years old.
- Unilateral pain in the anterolateral region of the shoulder.
- Has painful arc.
- 2 out of 3 impingement tests positive (Hawkins, Jobe and Neer).
- Pain with palpation of the supraspinatus tendon insertion.
Who cannot join
- Previous shoulder complex, cervical and thoracic fractures, or surgeries.
- Either cervical pain or arm radiculopathy.
- History of shoulder dislocation.
- Traumatic onset of the pain.
- No corticosteroid injections could have been received within 2 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Intensity Laser on Shoulder Impingement Syndrome in Adolescents
Treatment for shoulder impingement is conservative initially, Rehabilitation programs generally consist of exercise therapy and manual therapy that provide relief from symptoms of impingement. High-intensity laser therapy used recently and was found to be effective in the short term in the treatment of pain and disability in patients with impingement.
This study aims to
Read more
- Investigate the effect of high intensity power laser therapy on sonographic measurement in the adolescent suffering from shoulder impingement syndrome.
- Investigate the effect of high intensity power laser therapy on pain in the adolescent suffering from shoulder impingement syndrome.
- Investigate the effect of high intensity power laser therapy on shoulder function in the adolescent suffering from shoulder impingement syndrome.
RESEARCH QUESTION:
Does using high intensity power laser affects shoulder dysfunction in adolescent with shoulder impingement syndrome?
Read the detailed description
Shoulder symptoms are often persistent and recurrent and represents approximately one fifth of all musculoskeletal disability payment. One of the most common causes of shoulder pain is the occurrence of tendinopathy resulting from the impingement of rotator cuff tendons under the coracoacromial arch which refer to impingement syndrome.
Treatment for shoulder impingement is conservative initially, Rehabilitation programs generally consist of exercise therapy that provide relief from symptoms of impingement, Exercise therapy has been shown to be effective in the reducing pain and improving function also it was stated that the exercise therapy lead to improving shoulder musculoskeletal risk factors in competitive athletes with Specific exercise was superior to non-specific exercise. Strong recommendation may be made to include manual therapy as an adjunct intervention with exercise.
The manual therapy technique of joint mobilizations which are commonly used by physiotherapists for reducing pain and disability in patients with shoulder musculoskeletal disorders, Manual therapy which involves realigning collagen, enhancing fiber slip, reducing adhesion, and re-establishing correct gleno-humeral joint kinematics, can relieve pain by stimulating peripheral mechanical receptors, suppressing nociceptors, boosting synovial fluid nutrition, and reducing adhesion. It has been stated that impingement patients treated with manual therapy in combination with supervised exercise showed improvement in pain and function.
High-intensity laser therapy (HILT) is a treatment method that added to therapeutic interventions recently. HILT improves the microcirculation and tissue regeneration with photomechanic effects in deep tissues. Biostimulation, anti-inflammatory, and analgesic properties contribute to an effective improvement in painful bone-muscle-joint pathologies, including shoulder problems. Adding therapeutic interventions to laser therapy is usual in clinical practice. HILT was found to be effective in the short term in the treatment of pain and disability in patients with Sub-acromial pain syndrome.
Ultrasonography is recommended as the first line imaging tool to evaluate sports injuries; it has been used as the preferred technique for evaluating the subacromial space.
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. . This technique is a well-known and well-validated method to induce acute experimental pain.
Null Hypothesis:
High intensity laser therapy will not affect the sonographic measurement in adolescents with shoulder impingement syndrome.
High intensity laser therapy will not affect the pain in adolescents with shoulder impingement syndrome.
High intensity power laser therapy will not affect the shoulder function in adolescents suffering from shoulder impingement syndrome.
Basic assumptions:
It will be assumed that:
- All evaluation and treatment procedures will be performed in the same environment for all patients
- All volunteers will attend the treatment program regularly.
- All volunteers will be cooperative, following the instructions given to them, and exert their maximum effort during the study.
- The results of the study will be helpful for physical therapists dealing with similar cases.
- Being tested
- high intensity laser, manual therapy, exercise therapy
- Keywords
- high intensity laser, shoulder impingement, manual therapy, exercise therapy, shoulder dysfunction, shoulder function, pain, adolescents
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity laserDevice
the patient will be in supine position with shoulder uncovered from clothes and wearing laser protective eye glass to protect eye from laser radiation, the dose will be selected from device pathologies list programs number thirty-four with 30% power, frequency continuous, density 16 j/cm2, time automatically adjusted by the device according to the width of scanning area ( superiorly from the acromioclavicular joint down to end of biceps tendon and medially from the coracoid process to the middle fiber of deltoid laterally) and the infrared will be ON.
manual therapyOther
manual therapy (mulligan shoulder abduction, deep transverse friction technique on the supraspinatus tendon, scapular mobilization, caudal and posterior humeral mobilization) three session weekly over 5 weeks.
exercise therapyOther
therapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch supine ex, pectoralis minor flexibility (focused and gross stretch) and posterior capsule modified sleeper stretching ex's from side)
| Study group | Role | What they receive |
|---|---|---|
| group A: manual therapy and exercise | Active comparator | will receive the therapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch ex, pectoralis minor flexibility and posterior capsule modified sleeper stretching ex's) and manual therapy (mulligan abduction, deep transverse friction technique on the supraspinatus muscle, scapular mobilization, caudal and posterior humeral mobilization), they will receive 15 consecutive sessions (three session weekly over 5 weeks). Receives: Other: manual therapy; Other: exercise therapy |
| group (B): high intensity laser, manual therapy, exercise therapy | Experimental | will receive high intensity laser therapy (PAGANI scanner 16 j/cm2, high power laser BI-POWER SN/ 477 made in Italy will be used)three sessions weekly over 5 weeks. the patient will be in supine position with shoulder uncovered from clothes and wearing laser protective eye glass, the dose will be selected from device pathologies list programs number thirty-four with 30% power, frequency continuous, density 16 j/cm2, time automatically adjusted by the device according to the width of scanning area ( superiorly from the acromioclavicular joint down to end of biceps tendon and medially from the coracoid process to the middle fiber of deltoid laterally) and the infrared will be ON.
therapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch ex, pectoralis minor flexibility and posterior capsule modified sleeper stretching ex's) and manual therapy (mulligan abduction, deep transverse friction on supraspinatus, scapular mobilization, caudal and posterior humerla glide) Receives: Device: high intensity laser; Other: manual therapy; Other: exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromio-humeral distance (AHD) and Coraco-humeral distance (CHD).
Musculoskeletal Ultrasound (TOSHIBA Aplio 500, japan. Linear probe 12-15 MHZ) will be used to measure both distance (AHD\& CHD) with the injured shoulder in two angles 0- and 60-degrees abduction from scapular plane (40° front of the frontal plane). The subjects were instructed to sit upright in the chair and to place their feet on the floor with knees and hips 90 degrees flexion. the examiner took one ultrasound image at angle 0-degree abduction as thepatient's arm rest beside the body with the palm toward the body and the other image from 60 abduction from scaption. acromio-humeral distance calculated by measuring the linear distance from the most lateral edge of the acromion to the most proximal portion of the humeral head. Then for calculation of the coraco-humeral distance the ultrasound transducer was placed over the most anterior aspect of the shoulder, observing the coracoid process and the humeral head on the screen, taking the shortest distance between them (in centimeters).
Measured: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
pain.
pain: BASLINE push pull force gauge algometer (White Plains, New York 10602 USA) will be used to assess patient pain. An algometer can be used to objectively measure the first point of pressure required to produce symptoms at the most painful points in the long head of biceps tendon, under acromion area and deltoid with the patient relaxed and the affected shoulder will be uncovered from clothes.
Measured: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
Function.
Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability which take less than five minutes to complete. The examiner will describe to the patient the two scale parts, the pain scale that is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best, 100 indicates worst. A higher score shows more disability. In scoring SPADI, any question missed should be taken out of the total score of each subscale. i.e if 1 question is omitted in the pain section, the total score is divided by 40.
Measured: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start18 Feb 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity LaserStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Pretest posttest randomized controlled trail.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elkhalek Mansour Ahmed, Cairo University
- Investigators
- Abd ELkhalek Mansour Ahmed, MSC, DPT, Study director, physical therapist, Al Azhar university hospital, Sayed Galal hospitalKhaled Ahmed olama, professor, Study director, Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo Universitymohamed Ali Elshafey, professor, Study director, Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo Universityhatem Mohamed El-Azizi, professor, Study director, Radiology Department, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732570
- Sponsor's protocol ID
- high power laser for shoulder
- Acronym
- lasershoulder
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Laser on Shoulder Impingement Syndrome in Adolescents
- ClinicalTrials.gov ID
- NCT06732570
- Acronym / sponsor ID
- lasershoulder / high power laser for shoulder
- Keywords
- high intensity laser, shoulder impingement, manual therapy, exercise therapy, shoulder dysfunction, shoulder function, pain, adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
Treatment for shoulder impingement is conservative initially, Rehabilitation programs generally consist of exercise therapy and manual therapy that provide relief from symptoms of impingement. High-intensity laser therapy used recently and was found to be effective in the short term in the treatment of pain and disability in patients with impingement.
This study aims to
- Investigate the effect of high intensity power laser therapy on sonographic measurement in the adolescent suffering from shoulder impingement syndrome.
- Investigate the effect of high intensity power laser therapy on pain in the adolescent suffering from shoulder impingement syndrome.
- Investigate the effect of high intensity power laser therapy on shoulder function in the adolescent suffering from shoulder impingement syndrome.
RESEARCH QUESTION:
Does using high intensity power laser affects shoulder dysfunction in adolescent with shoulder impingement syndrome?
Detailed description
Shoulder symptoms are often persistent and recurrent and represents approximately one fifth of all musculoskeletal disability payment. One of the most common causes of shoulder pain is the occurrence of tendinopathy resulting from the impingement of rotator cuff tendons under the coracoacromial arch which refer to impingement syndrome.
Treatment for shoulder impingement is conservative initially, Rehabilitation programs generally consist of exercise therapy that provide relief from symptoms of impingement, Exercise therapy has been shown to be effective in the reducing pain and improving function also it was stated that the exercise therapy lead to improving shoulder musculoskeletal risk factors in competitive athletes with Specific exercise was superior to non-specific exercise. Strong recommendation may be made to include manual therapy as an adjunct intervention with exercise.
The manual therapy technique of joint mobilizations which are commonly used by physiotherapists for reducing pain and disability in patients with shoulder musculoskeletal disorders, Manual therapy which involves realigning collagen, enhancing fiber slip, reducing adhesion, and re-establishing correct gleno-humeral joint kinematics, can relieve pain by stimulating peripheral mechanical receptors, suppressing nociceptors, boosting synovial fluid nutrition, and reducing adhesion. It has been stated that impingement patients treated with manual therapy in combination with supervised exercise showed improvement in pain and function.
High-intensity laser therapy (HILT) is a treatment method that added to therapeutic interventions recently. HILT improves the microcirculation and tissue regeneration with photomechanic effects in deep tissues. Biostimulation, anti-inflammatory, and analgesic properties contribute to an effective improvement in painful bone-muscle-joint pathologies, including shoulder problems. Adding therapeutic interventions to laser therapy is usual in clinical practice. HILT was found to be effective in the short term in the treatment of pain and disability in patients with Sub-acromial pain syndrome.
Ultrasonography is recommended as the first line imaging tool to evaluate sports injuries; it has been used as the preferred technique for evaluating the subacromial space.
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. . This technique is a well-known and well-validated method to induce acute experimental pain.
Null Hypothesis:
High intensity laser therapy will not affect the sonographic measurement in adolescents with shoulder impingement syndrome.
High intensity laser therapy will not affect the pain in adolescents with shoulder impingement syndrome.
High intensity power laser therapy will not affect the shoulder function in adolescents suffering from shoulder impingement syndrome.
Basic assumptions:
It will be assumed that:
- All evaluation and treatment procedures will be performed in the same environment for all patients
- All volunteers will attend the treatment program regularly.
- All volunteers will be cooperative, following the instructions given to them, and exert their maximum effort during the study.
- The results of the study will be helpful for physical therapists dealing with similar cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pretest posttest randomized controlled trail.
| Arm | Type | Receives |
|---|---|---|
| group A: manual therapy and exercise | Active comparator | Other: manual therapy, Other: exercise therapywill receive the therapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch ex, pectoralis minor flexibility and posterior capsule modified sleeper stretching ex's) and manual therapy (mulligan abduction, deep transverse friction technique on the supraspinatus muscle, scapular mobilization, caudal and posterior humeral mobilization), they will receive 15 consecutive sessions (three session weekly over 5 weeks). |
| group (B): high intensity laser, manual therapy, exercise therapy | Experimental | Device: high intensity laser, Other: manual therapy, Other: exercise therapywill receive high intensity laser therapy (PAGANI scanner 16 j/cm2, high power laser BI-POWER SN/ 477 made in Italy will be used)three sessions weekly over 5 weeks. the patient will be in supine position with shoulder uncovered from clothes and wearing laser protective eye glass, the dose will be selected from device pathologies list programs number thirty-four with 30% power, frequency continuous, density 16 j/cm2, time automatically adjusted by the device according to the width of scanning area ( superiorly from the acromioclavicular joint down to end of biceps tendon and medially from the coracoid process to the middle fiber of deltoid laterally) and the infrared will be ON. therapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch ex, pectoralis minor flexibility and posterior capsule modified sleeper stretching ex's) and manual therapy (mulligan abduction, deep transverse friction on supraspinatus, scapular mobilization, caudal and posterior humerla glide) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age was ranged between 12-18 years old.
- Unilateral pain in the anterolateral region of the shoulder.
- Has painful arc.
- 2 out of 3 impingement tests positive (Hawkins, Jobe and Neer).
- Pain with palpation of the supraspinatus tendon insertion.
Key exclusion criteria (5 listed)
- Previous shoulder complex, cervical and thoracic fractures, or surgeries.
- Either cervical pain or arm radiculopathy.
- History of shoulder dislocation.
- Traumatic onset of the pain.
- No corticosteroid injections could have been received within 2 months prior to the study
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 |
|---|---|---|
| high intensity laserthe patient will be in supine position with shoulder uncovered from clothes and wearing laser protective eye glass to protect eye from laser radiation, the dose will be selected from device pathologies list programs number thirty-four with 30% power, frequency continuous, density 16 j/cm2, time automatically adjusted by the device according to the width of scanning area ( superiorly from the acromioclavicular joint down to end of biceps tendon and medially from the coracoid process to the middle fiber of deltoid laterally) and the infrared will be ON. | Device | group (B): high intensity laser, manual therapy, exercise therapy |
| manual therapymanual therapy (mulligan shoulder abduction, deep transverse friction technique on the supraspinatus tendon, scapular mobilization, caudal and posterior humeral mobilization) three session weekly over 5 weeks. | Other | group (B): high intensity laser, manual therapy, exercise therapy, group A: manual therapy and exercise |
| exercise therapytherapeutic exercises (rotator cuff strengthening, cools ex's, serratus punch supine ex, pectoralis minor flexibility (focused and gross stretch) and posterior capsule modified sleeper stretching ex's from side) | Other | group (B): high intensity laser, manual therapy, exercise therapy, group A: manual therapy and exercise |
Primary outcome
Acromio-humeral distance (AHD) and Coraco-humeral distance (CHD).
Time frame: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
Musculoskeletal Ultrasound (TOSHIBA Aplio 500, japan. Linear probe 12-15 MHZ) will be used to measure both distance (AHD\& CHD) with the injured shoulder in two angles 0- and 60-degrees abduction from scapular plane (40° front of the frontal plane). The subjects were instructed to sit upright in the chair and to place their feet on the floor with knees and hips 90 degrees flexion. the examiner took one ultrasound image at angle 0-degree abduction as thepatient's arm rest beside the body with the palm toward the body and the other image from 60 abduction from scaption. acromio-humeral distance calculated by measuring the linear distance from the most lateral edge of the acromion to the most proximal portion of the humeral head. Then for calculation of the coraco-humeral distance the ultrasound transducer was placed over the most anterior aspect of the shoulder, observing the coracoid process and the humeral head on the screen, taking the shortest distance between them (in centimeters).
pain.
Time frame: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
pain: BASLINE push pull force gauge algometer (White Plains, New York 10602 USA) will be used to assess patient pain. An algometer can be used to objectively measure the first point of pressure required to produce symptoms at the most painful points in the long head of biceps tendon, under acromion area and deltoid with the patient relaxed and the affected shoulder will be uncovered from clothes.
Function.
Time frame: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.
Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability which take less than five minutes to complete. The examiner will describe to the patient the two scale parts, the pain scale that is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best, 100 indicates worst. A higher score shows more disability. In scoring SPADI, any question missed should be taken out of the total score of each subscale. i.e if 1 question is omitted in the pain section, the total score is divided by 40.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Abd ELkhalek Mansour Ahmed, MSC, DPT study director
physical therapist, Al Azhar university hospital, Sayed Galal hospital
Khaled Ahmed olama, professor study director
Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo University
mohamed Ali Elshafey, professor study director
Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo 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 high intensity laser, manual therapy and exercise therapy in people with High Intensity Laser and Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acromio-humeral distance (AHD) and Coraco-humeral distance (CHD). (time frame: measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.). The study lists 3 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 13 Dec 2024.