Effect of High Intensity Laser on Shoulder Impingement.

NCT ID: NCT06732570

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2026-12-30

Brief 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. 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.

Conditions

High Intensity Laser; Shoulder Impingement Syndrome; Shoulder Pain

Keywords

high intensity laser, shoulder impingement, manual therapy, exercise therapy, shoulder dysfunction; shoulder function; pain; adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A: manual therapy and exercise

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).

Group Type: ACTIVE_COMPARATOR

manual therapy

Intervention Type: OTHER

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 therapy

Intervention Type: OTHER

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)

group (B): high intensity laser, manual therapy, exercise therapy

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)

Group Type: EXPERIMENTAL

high intensity laser

Intervention Type: DEVICE

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 therapy

Intervention Type: OTHER

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 therapy

Intervention Type: OTHER

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)

Interventions

high intensity laser

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.

Intervention Type: DEVICE

manual therapy

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.

Intervention Type: OTHER

exercise therapy

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age was ranged between 12-18 years old.

2. Unilateral pain in the anterolateral region of the shoulder.

3. Has painful arc.

4. 2 out of 3 impingement tests positive (Hawkins, Jobe and Neer).

5. Pain with palpation of the supraspinatus tendon insertion.

Exclusion Criteria

1. Previous shoulder complex, cervical and thoracic fractures, or surgeries.

2. Either cervical pain or arm radiculopathy.

3. History of shoulder dislocation.

4. Traumatic onset of the pain.

5. No corticosteroid injections could have been received within 2 months prior to the study

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abd Elkhalek Mansour Ahmed

physical therapist, Al Azhar university hospital, MSC, DPT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abd ELkhalek Mansour Ahmed, MSC, DPT

Role: STUDY_DIRECTOR

physical therapist, Al Azhar university hospital, Sayed Galal hospital

Khaled Ahmed olama, professor

Role: STUDY_DIRECTOR

Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo University

mohamed Ali Elshafey, professor

Role: STUDY_DIRECTOR

Physical Therapy, Department for Physical Therapy for pediatrics Faculty of Physical Therapy Cairo University

hatem Mohamed El-Azizi, professor

Role: STUDY_DIRECTOR

Radiology Department, Faculty of Medicine, Cairo University

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

high power laser for shoulder

Identifier Type: -

Identifier Source: org_study_id