NCT05624866

Brief Summary

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modalities are available for treatment of mild to moderate CTS.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 10, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

October 31, 2023

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 31, 2022

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

    visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

    6 months

Secondary Outcomes (1)

  • change of cross sectional area of the median nerve

    6 months

Study Arms (2)

Dexmeditomidine group

ACTIVE COMPARATOR

injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection

Drug: Dexmedetomidine

Triamcinolone group

ACTIVE COMPARATOR

injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection

Drug: Triamcinolone

Interventions

injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection

Dexmeditomidine group

injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection

Triamcinolone group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients
  • complaining of carpal tunnel syndrome of 3 month duration or more
  • diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

You may not qualify if:

  • patient refusal
  • infection at the site of intervention
  • allergy to utilized drugs
  • diabetic
  • previous surgery in the site of injection
  • previous injection in the targeted site within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Universit Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

DexmedetomidineTriamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 22, 2022

Study Start

October 10, 2022

Primary Completion

November 10, 2023

Study Completion

December 10, 2023

Last Updated

October 31, 2023

Record last verified: 2022-11

Locations