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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06703775
Enrollment
66
Registered
2024-11-25
Start date
2024-11-26
Completion date
2025-02-01
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

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.

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.

OTHERConventional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arabic version of Shoulder Pain and Disability Index (SPADI)4 weeksThe 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

MeasureTime frameDescription
Measurement of shoulder flexion range of motion (ROM)4 weeksIt 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).
Measurement of shoulder abduction range of motion (ROM)4 weeksIt 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).
Measurement of shoulder external rotation range of motion (ROM)4 weeksIt 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.
Measurement of maximum isometric force (MIF) of shoulder abductors4 weeksThe 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.

Countries

Egypt

Contacts

Primary ContactHayam Abd Elrazek Mohamed, M.Sc
hayamabdelrazek589@gmail.com01092710752
Backup ContactHussein Gamal Hussein Mogahed, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026