Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome Pregnancy
• Interventions: Device: bioptron light therapy; Device: wrist brace

• Registration Number: NCT06209918
• Lead Sponsor: Cairo University

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)

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-07-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group that recieve bioptron light and advice and patient education	bioptron light therapy	patients will recieve bioptron light therapy for 10 minutes per session, 3 sessions per week, for 4 weeks.
control group that recieve advice and patient education and wrist brace	wrist brace	will keep the wrist in a neutral position, not bent back or bent down too far

Primary Outcome Measures

Name	Time	Method
Nerve conduction studies (NCS)	4 weeks	assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale	4 weeks	assess pain intensity

Trial Locations

Locations (1)

Sara Magdy Ahmed; 🇪🇬 Giza, Egypt