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

NCT06703775 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005253
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Arabic version of Shoulder Pain and Disability Index (SPADI)

  The SPADI is a self-reported questionnaire with 13 items divided into two subscales: pain and disability. The pain subscale includes five questions about pain intensity during specific activities, such as lying on the involved side, reaching for a high shelf, or pushing with the involved arm. The disability subscale has eight questions about difficulty with tasks like washing hair, putting on clothing, or carrying a 10-pound object. Each question is rated on an 11-point scale (0-10). Scores are summed, converted to percentages, and averaged to provide a total SPADI score ranging from 0 (best) to 100 (worst). SPADI will be assessed pre- and post-treatment (4 weeks).

  4 weeks

Secondary Outcomes (4)

• Measurement of shoulder flexion range of motion (ROM)

  4 weeks

• Measurement of shoulder abduction range of motion (ROM)

  4 weeks

• Measurement of shoulder external rotation range of motion (ROM)

  4 weeks

• Measurement of maximum isometric force (MIF) of shoulder abductors

  4 weeks

Study Arms (3)

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

EXPERIMENTAL

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.

Other: Low level laser therapy (LLLT); Other: Conventional physical therapy program

Neural mobilization techniques + Conventional physical therapy program

EXPERIMENTAL

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.

Other: Neural mobilization techniques; Other: Conventional physical therapy program

Conventional physical therapy program

ACTIVE COMPARATOR

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.

Other: Conventional physical therapy program

Interventions

Low level laser therapy (LLLT) 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.

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

Neural mobilization techniques 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.

Neural mobilization techniques + Conventional physical therapy program

Conventional physical therapy program 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; Low level laser therapy (LLLT) + Conventional physical therapy program; Neural mobilization techniques + Conventional physical therapy program

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Amal Mohamed Abd El-baky, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Hayam Abd Elrazek Mohamed, M.Sc

CONTACT

01092710752; hayamabdelrazek589@gmail.com

Hussein Gamal Hussein Mogahed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 26, 2024
• Primary Completion: January 26, 2025
• Study Completion: February 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

EG (1)