Effect of High Intensity Laser on Shoulder Impingement.

NCT06732570 | Active Not Recruiting DMC FDA Device

• 1 other identifier: high power laser for shoulder
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  measurements will be done pre and post 5 weeks (15 sessions, three sessions per week) of interventions.

Study Arms (2)

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).

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)

Device: high intensity laser; Other: manual therapy; Other: exercise therapy

Interventions

high intensity laser 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.

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

manual therapy 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.

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

exercise therapy 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; group A: manual therapy and exercise

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age was ranged between 12-18 years old.
• Unilateral pain in the anterolateral region of the shoulder.
• Has painful arc.
• out of 3 impingement tests positive (Hawkins, Jobe and Neer).
• Pain with palpation of the supraspinatus tendon insertion.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain; Pain

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Abd ELkhalek Mansour Ahmed, MSC, DPT

  physical therapist, Al Azhar university hospital, Sayed Galal hospital

  STUDY DIRECTOR

• Khaled Ahmed olama, professor

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

  STUDY DIRECTOR

• mohamed Ali Elshafey, professor

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

  STUDY DIRECTOR

• hatem Mohamed El-Azizi, professor

  Radiology Department, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist, Al Azhar university hospital, MSC, DPT

Model Details: Pretest posttest randomized controlled trail.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 13, 2024
• Study Start: February 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

EG (1)