Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)

Effect of Bioptron Light Therapy on Pregnancy Related Carpal Tunnel Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome Pregnancy
• Intervention / Treatment: Device: bioptron light therapy; Device: wrist brace

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Ma Ahmed, lecturer; Phone Number: 01063998331; Email: saramagdy87@cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Sara Magdy Ahmed
    • Contact: Sara Ma Ahmed, lecturer; Phone Number: 01063998331; Email: saramagdy87@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Other: 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	Device: wrist brace; will keep the wrist in a neutral position, not bent back or bent down too far

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve conduction studies (NCS)	assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	assess pain intensity	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston carpal tunnel questionnaire	Assess Symptom severity and functional capacity	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Sara Ma Ahmed, lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Phototherapy; Carpal tunnel syndrome; Bioptron light therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: P.T.REC/012/003875

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No