NCT06555926

Brief Summary

This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 13, 2024

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of pain severity

    The pain intensity will be assessed for all participants in both groups before and after treatment through VAS. It is a 10 cm horizontal line on which the participant's pain intensity will be represented by a point between the extremes of "no pain at all" and "worst imaginable pain". Each participant will be asked to mark a point on a VAS line between the extremes that related to her current pain intensity

    12 weeks

  • median nerve conduction study

    Computerized Electromyography (Dantce): ATOENINIES neuro screen system will be used to perform median nerve conduction study before and after the treatment program for all participants in both groups

    12 weeks

Study Arms (2)

Acupressure group

EXPERIMENTAL

The pregnant women will receive acupressure and advice for 12 weeks

Other: AcupressureOther: advices for relieving carpal tunnel syndrome

Advice group

ACTIVE COMPARATOR

The pregnant women will receive advice only for 12 weeks

Other: advices for relieving carpal tunnel syndrome

Interventions

The pregnant women will receive acupressure on the (Pc-6/Lung-7 )acupoints one minute for each point with 3 repetitions on both side( about 30minutes /session),2 times per week in addition to advices for 12 weeks.

Acupressure group

The pregnant women will receive advices for 12 weeks as follows: * Avoid heavy lifting. * Avoid repetitive tasks. * Sit on chairs with armrests and elevate affected hand on the armrest * Avoid sleeping on the side of the affected hand. * Keep the wrist in a neutral (straight) position. * Avoid positions of full flexion and extension. * Reduce general swelling by: * eating less salty food . * elevating legs when sitting . * wearing compression garments. * Apply cold water over the wrist.

Acupressure groupAdvice group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who are clinically diagnosed as having carpal tunnel syndrome .
  • Their age will be ranged from 20 to 35years old.
  • Their body mass index will not exceed 30kg/m2.
  • All of them are in their 3rd trimester of pregnancy.(28-40weeks)
  • All of them suffer from mild and moderate CTS.
  • Degree of carpal tunnel pain will be 2 or more on Visual Analogue scale.

You may not qualify if:

  • Dermatological abnormalities in the skin of acupionts.
  • Internal fixation at the area of acupressure application.
  • Smokers .
  • Metabolic diseases such as Diabetes mellitus.
  • Females who had history of fracture or trauma to the hand .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

AcupressureCounseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Azza Nashed, professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

bassant ahmed, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 15, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL