NCT05932381

Brief Summary

this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

June 27, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

July 6, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 27, 2023

Last Update Submit

June 27, 2023

Conditions

Keywords

complete decongestive therapycarpal tunnel syndromeupper limb lymphedema

Outcome Measures

Primary Outcomes (2)

  • hand strength

    hand held dynamometer will be used for measuring the hand strength

    up to ten weeks

  • median nerve conduction velocity

    median nerve conduction velocity will be measured by electromyography device

    up to ten weeks

Secondary Outcomes (1)

  • pain intensity

    up to ten weeks

Study Arms (2)

Complete decongestive therapy

EXPERIMENTAL

the patients will receive complete decongestive therapy twice a week for ten weeks

Other: Complete decongestive therapyOther: Medical treatment

medical treatment

ACTIVE COMPARATOR

the patients will receive routine medical treatment for ten weeks

Other: Medical treatment

Interventions

the patients will receive Complete decongestive therapy in the form of intermittent pneumatic compression, Exercising, bandaging, and manual lymphatic drainage with Pressures of 50, 80, and 120 mmHg and timing 5, 20, and 50 secs

Complete decongestive therapy

the patients will receive routine medical treatment

Complete decongestive therapymedical treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age will range between 20- 40 years.
  • Only females will participate in the study.
  • All patients have carpal tunnel syndrome post upper limb lymphedema.

You may not qualify if:

  • Diabetes mellitus.
  • Individuals with cardiopulmonary conditions.
  • Individuals undergoing radiation therapy or chemotherapy.
  • Hepatic or pancreatic diseases.
  • Sensory impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphedemaCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: complete decongestive therapy and routine medical treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator Sara Abd Elmohsen Ali

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 5, 2023

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

July 6, 2023

Record last verified: 2023-06