NCT06209918

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

July 21, 2023

Last Update Submit

January 17, 2024

Conditions

Carpal Tunnel Syndrome Pregnancy

Keywords

Bioptron light therapyPhototherapyCarpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

  • Nerve conduction studies (NCS)

    assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential

    4 weeks

Secondary Outcomes (1)

  • Visual analogue scale

    4 weeks

Other Outcomes (1)

  • Boston carpal tunnel questionnaire

    4 weeks

Study Arms (2)

group that recieve bioptron light and advice and patient education

EXPERIMENTAL

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

Device: bioptron light therapy

control group that recieve advice and patient education and wrist brace

OTHER

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

Device: wrist brace

Interventions

bioptron light therapyDEVICE

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.

group that recieve bioptron light and advice and patient education
wrist braceDEVICE

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

control group that recieve advice and patient education and wrist brace

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women having carpal tunnel syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Magdy Ahmed

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Sara Ma Ahmed, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ma Ahmed, lecturer

CONTACT

01063998331saramagdy87@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 21, 2023

First Posted

January 18, 2024

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

EG(1)