Low Level Laser Versus Neural Mobilization of Brachial Plexus on Shoulder Dysfunction Post Liver Donation

NCT ID: NCT06703775

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2025-02-01

Brief Summary

The purpose of the study will be to compare therapeutic effect of low level laser versus neural mobilization techniques on shoulder dysfunction post liver donation.

Detailed Description

The need for this study develops from the lack of information in the published studies about the effectiveness of low level laser and neural mobilization of brachial plexus on shoulder dysfunction post liver donation.

Following liver donation and transplantation, shoulder dysfunction and discomfort occur in 20% to 60% of patients.

Low-level laser therapy (LLLT) has been used as a non-pharmacological alternative to treat painful musculoskeletal conditions. It is used in acute, chronic painful and inflammatory affections shows that low energy irradiation from lasers alters cellular processes, producing anti-inflammatory effects and increased collagen turnover.

Neural mobilization (NM) is an intervention aimed at restoring the homeostasis in and around the nervous system, by mobilization of the nervous system itself or the structures that surround the nervous system. Neural mobilization facilitates movement between neural structures and their surroundings (interface) through manual techniques or exercise. Human and animal studies revealed that NM reduces intraneural edema, improves intraneural fluid dispersion, reduces thermal and mechanical hyperalgesia and reverses the increased immune responses.

The present study is designed to investigate the effect of LLLT versus NMT on shoulder dysfunction post liver donation.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low level laser therapy (LLLT) + Conventional physical therapy program

This group will be composed of 22 patients with shoulder dysfunction post liver donation. Patients will receive low level laser in addition to conventional physical therapy program. LLLT will be applied for 3 times a week for 4 consecutive weeks.

Group Type: EXPERIMENTAL

Low level laser therapy (LLLT)

Intervention Type: OTHER

The first experimental will receive LLLT using the Fisioline Lumix 2 (Italy). Participants will be placed in a comfortable, supported sitting position and will wear protective eyeglasses to prevent retinal damage. The LLLT (GaAs type, 1-10 mW, 904 nm) will be applied to the most painful points on the deltoid and/or upper trapezius muscles. Treatment will target a minimum of two and a maximum of four painful points, with each point irradiated for 3-4 minutes, for a total session duration of up to 15 minutes.

Conventional physical therapy program

Intervention Type: OTHER

The following exercises will be performed by the patients of three groups. Pendulum exercise, Isometric Scapular Retraction, Rotator cuff exercise, Wall creeping exercise, Active assisted ROM exercises, Codman exercises. Each exercise will be performed for all movements namely flexion extension and abduction-adduction, one sets of each 10-15 repetitions within pain-free range and instructed to carry out their activities of daily living.

Neural mobilization techniques + Conventional physical therapy program

This group will be composed of 22 patients with shoulder dysfunction post liver donation. Patients will receive neural mobilization techniques in addition to conventional physical therapy program. Exercises will be applied for 3 times a week for 4 consecutive weeks.

Group Type: EXPERIMENTAL

Neural mobilization techniques

Intervention Type: OTHER

The second experimental will receive Neural Mobilization Therapy (NMT). The procedure will begin by positioning the patient in a sitting position. The initial positioning will involve placing the patient's arm at their side with the elbow bent at 90 degrees. The therapist will gently extend the patient's shoulder (moving the arm backward) while keeping the elbow bent, creating tension on the axillary nerve. This tension will be held for a few seconds, ensuring it remains within the patient's tolerance and does not cause discomfort or pain. The shoulder will then be slowly returned to the initial position, releasing the tension on the nerve. This sequence of tension and release will be repeated, gradually increasing the range of motion as tolerated. The treatment will consist of three sets of 10 repetitions, with a one-minute rest between sets, performed three times per week for a total of 12 sessions over four weeks.

Conventional physical therapy program

Intervention Type: OTHER

The following exercises will be performed by the patients of three groups. Pendulum exercise, Isometric Scapular Retraction, Rotator cuff exercise, Wall creeping exercise, Active assisted ROM exercises, Codman exercises. Each exercise will be performed for all movements namely flexion extension and abduction-adduction, one sets of each 10-15 repetitions within pain-free range and instructed to carry out their activities of daily living.

Conventional physical therapy program

This group will be composed of 22 patients with shoulder dysfunction post liver donation. Patients will receive conventional physical therapy program. Exercises will be applied for 3 times a week for 4 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type: OTHER

The following exercises will be performed by the patients of three groups. Pendulum exercise, Isometric Scapular Retraction, Rotator cuff exercise, Wall creeping exercise, Active assisted ROM exercises, Codman exercises. Each exercise will be performed for all movements namely flexion extension and abduction-adduction, one sets of each 10-15 repetitions within pain-free range and instructed to carry out their activities of daily living.

Interventions

Low level laser therapy (LLLT)

The first experimental will receive LLLT using the Fisioline Lumix 2 (Italy). Participants will be placed in a comfortable, supported sitting position and will wear protective eyeglasses to prevent retinal damage. The LLLT (GaAs type, 1-10 mW, 904 nm) will be applied to the most painful points on the deltoid and/or upper trapezius muscles. Treatment will target a minimum of two and a maximum of four painful points, with each point irradiated for 3-4 minutes, for a total session duration of up to 15 minutes.

Intervention Type: OTHER

Neural mobilization techniques

The second experimental will receive Neural Mobilization Therapy (NMT). The procedure will begin by positioning the patient in a sitting position. The initial positioning will involve placing the patient's arm at their side with the elbow bent at 90 degrees. The therapist will gently extend the patient's shoulder (moving the arm backward) while keeping the elbow bent, creating tension on the axillary nerve. This tension will be held for a few seconds, ensuring it remains within the patient's tolerance and does not cause discomfort or pain. The shoulder will then be slowly returned to the initial position, releasing the tension on the nerve. This sequence of tension and release will be repeated, gradually increasing the range of motion as tolerated. The treatment will consist of three sets of 10 repetitions, with a one-minute rest between sets, performed three times per week for a total of 12 sessions over four weeks.

Intervention Type: OTHER

Conventional physical therapy program

The following exercises will be performed by the patients of three groups. Pendulum exercise, Isometric Scapular Retraction, Rotator cuff exercise, Wall creeping exercise, Active assisted ROM exercises, Codman exercises. Each exercise will be performed for all movements namely flexion extension and abduction-adduction, one sets of each 10-15 repetitions within pain-free range and instructed to carry out their activities of daily living.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients are both males and females.
• Their age will range from (20-50) years.
• Patients will suffer from unilateral shoulder pain(Rt shoulder).
• Patients will begin the training program one week post.operative.
• All patients will suffer from moderate to severe pain (VAS score > 4).
• Patients will be given their informed consent.

Exclusion Criteria

• Known history of high level Spinal cord injury and malignancy
• Metabolic disease with a neurological component such as diabetes.
• Orthopedic disorders such as fracture or dislocation.
• Musculoskeletal disorders that will impair performance during training and tests.
• Uncontrolled cardiovascular or pulmonary diseases .
• Circulatory disturbances of upper extremity
• Psychiatric illness, severe behavior or cognitive disorders.
• Uncooperative patients.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hayam Abd Elrazek Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Mohamed Abd El-baky, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

faculty of physical therapy, Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Hayam Abd Elrazek Mohamed, M.Sc

Role: CONTACT

hayamabdelrazek589@gmail.com

01092710752

Hussein Gamal Hussein Mogahed, PhD

Role: CONTACT

Facility Contacts

Hayam Abd Elrazek Mohamed, M.Sc

Role: primary

hayamabdelrazek589@gmail.com

Other Identifiers

P.T.REC/012/005253

Identifier Type: -

Identifier Source: org_study_id