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NCT Number: NCT06703775

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

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.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Cairo University

Giza, Egypt

Location contact

Hayam Abd Elrazek Mohamed, M.Sc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Arabic version of Shoulder Pain and Disability Index (SPADI)

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. Measurement of shoulder flexion range of motion (ROM)

    Time frame: 4 weeks

    It will be measured from supine lying position, using a digital goniometer. The starting position for the participant's arm will be beside his body with the elbow extended and the thumb pointing upward. The axis of measurement will be the lateral part of greater tubercle and the lateral epi-condyle as the reference point. The fixed arm will be placed parallel to the surface of the floor, the movable arm will be placed parallel to the lateral aspect of the upper arm (humerus).

  2. Measurement of shoulder abduction range of motion (ROM)

    Time frame: 4 weeks

    It will be measured from supine lying position, using a digital goniometer. The starting position for the participant's arm will be laterally rotated beside his body with the elbow extended and palm facing upward without flexion or extension of shoulder. The axis of measurement will be the anterior aspect of the acromion process and the medial epicondyle as the reference point. The fixed arm will be placed parallel to the surface of the floor, the movable arm will be placed parallel to the anterior aspect of the upper arm (humerus).

  3. Measurement of shoulder external rotation range of motion (ROM)

    Time frame: 4 weeks

    It will be measured from supine lying position, using a digital goniometer. The starting position for the participant's arm was abducted 900 and elbow flexed 90° with the forearm perpendicular on the plinth, with his palm facing toward his feet without forearm pronation or supination and elbow outside plinth, a small pad was used under the humerus to be in level with the acromion. The distal end of humerus, thorax, and clavicle was stabilized. The axis of measurement was the olecranon process, and the ulnar styloid process as the reference point.

  4. Measurement of maximum isometric force (MIF) of shoulder abductors

    Time frame: 4 weeks

    The maximum isometric force (MIF) of shoulder abductors will be measured before and after treatment period using Lafayette hand-held dynamometer. The MIF will be measured through an accommodating isometric "make" test, where participants applied maximal force against the examiner while a steady position was maintained. Participants will perform three, 5 seconds contractions for each muscle group with a 30 second rest after each trial and 5 minutes rest between muscle groups. The average force of the three testing trials will be computed for each muscle. The examiner encourages participants to do their best effort during measurement.

Study contacts

Contact information is provided by the study sponsor or research team.

Hayam Abd Elrazek Mohamed, M.Sc

CONTACT

[email protected]

01092710752

Hussein Gamal Hussein Mogahed, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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