Shoulder PainNCT06703775
Low Level Laser Versus Neural Mobilization of Brachial Plexus on Shoulder Dysfunction Post Liver Donation
A study testing Low level laser therapy (LLLT), Neural mobilization techniques and Conventional physical therapy program in people with Shoulder Pain, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Low level laser therapy (LLLT), Neural mobilization techniques and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hussein Gamal Hussein Mogahed, PhD contact
Egypt1 site
faculty of physical therapy, Cairo University
Giza
Hayam Abd Elrazek Mohamed, M.Sc, hayamabdelrazek589@gmail.com
About this study
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.
Read the 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
- Being tested
- Low level laser therapy (LLLT), Neural mobilization techniques, Conventional physical therapy program
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 techniquesOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (4)
Measurement of shoulder flexion range of motion (ROM)
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).
Measured: 4 weeks
Measurement of shoulder abduction range of motion (ROM)
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).
Measured: 4 weeks
Measurement of shoulder external rotation range of motion (ROM)
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.
Measured: 4 weeks
Measurement of maximum isometric force (MIF) of shoulder abductors
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Nov 2024 (estimated)
- Primary completion26 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Abd Elrazek Mohamed, Cairo University
- Investigators
- Amal Mohamed Abd El-baky, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703775
- Sponsor's protocol ID
- P.T.REC/012/005253
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Versus Neural Mobilization of Brachial Plexus on Shoulder Dysfunction Post Liver Donation
- ClinicalTrials.gov ID
- NCT06703775
- Acronym / sponsor ID
- P.T.REC/012/005253
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (estimated)
- Primary completion
- 26 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy (LLLT) + Conventional physical therapy program | Experimental | Other: Low level laser therapy (LLLT), Other: Conventional physical therapy programThis 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. |
| Neural mobilization techniques + Conventional physical therapy program | Experimental | Other: Neural mobilization techniques, Other: Conventional physical therapy programThis 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. |
| Conventional physical therapy program | Active comparator | Other: Conventional physical therapy programThis 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Low level laser therapy (LLLT) + Conventional physical therapy program |
| Neural mobilization techniquesThe 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. | Other | Neural mobilization techniques + Conventional physical therapy program |
| Conventional physical therapy programThe 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. | Other | Conventional physical therapy program, Low level laser therapy (LLLT) + Conventional physical therapy program, Neural mobilization techniques + Conventional physical therapy program |
Primary outcome
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).
4 secondary outcomes
Measurement of shoulder flexion range of motion (ROM)
Time frame: 4 weeks
Measurement of shoulder abduction range of motion (ROM)
Time frame: 4 weeks
Measurement of shoulder external rotation range of motion (ROM)
Time frame: 4 weeks
Measurement of maximum isometric force (MIF) of shoulder abductors
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hussein Gamal Hussein Mogahed, PhD contact
Amal Mohamed Abd El-baky, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy (LLLT), Neural mobilization techniques and Conventional physical therapy program in people with Shoulder Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayam Abd Elrazek Mohamed, M.Sc (01092710752, hayamabdelrazek589@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic version of Shoulder Pain and Disability Index (SPADI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.