Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)

NCT ID: NCT06209918

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome

Detailed Description

Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)

Conditions

Carpal Tunnel Syndrome Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group that recieve bioptron light and advice and patient education

patients will recieve bioptron light therapy for 10 minutes per session, 3 sessions per week, for 4 weeks.

Group Type: EXPERIMENTAL

bioptron light therapy

Intervention Type: DEVICE

patient will be sitting on comfortable chair with the hand placed on an armrest in an extended and supinated position. Firstly, the skin over the wrist area will be exposed and cleaned by alcohol to achieve maximal penetration of light. Then, the bioptron device will be held perpendicular to the surface of the treated area, at a distance of 10 cm.

control group that recieve advice and patient education and wrist brace

will keep the wrist in a neutral position, not bent back or bent down too far

Group Type: OTHER

wrist brace

Intervention Type: DEVICE

will keep the wrist in a neutral position, not bent back or bent down too far

Interventions

bioptron light therapy

patient will be sitting on comfortable chair with the hand placed on an armrest in an extended and supinated position. Firstly, the skin over the wrist area will be exposed and cleaned by alcohol to achieve maximal penetration of light. Then, the bioptron device will be held perpendicular to the surface of the treated area, at a distance of 10 cm.

Intervention Type: DEVICE

wrist brace

will keep the wrist in a neutral position, not bent back or bent down too far

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month
• age will range from (25-35) years.
• body mass index (BMI) will be (BMI ≤ 35 kg/m2)

Exclusion Criteria

• history of neurologic disease
• hand surgery
• hand trauma,
• diabetes mellitus
• cervical spondylosis
• osteoarthritis of cervical spine and wrist joint
• chronic renal failure
• heart failure
• connective tissue disorders

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Magdy Ahmed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Ma Ahmed, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Sara Magdy Ahmed

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sara Ma Ahmed, lecturer

Role: CONTACT

saramagdy87@cu.edu.eg

01063998331

Facility Contacts

Sara Ma Ahmed, lecturer

Role: primary

saramagdy87@cu.edu.eg

01063998331

Other Identifiers

P.T.REC/012/003875

Identifier Type: -

Identifier Source: org_study_id