NCT04434105

Brief Summary

Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_2

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

February 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

June 14, 2020

Last Update Submit

June 15, 2020

Conditions

Carpal Tunnel Syndrome

Keywords

PRP injectionLocal injectionCTS

Outcome Measures

Primary Outcomes (3)

  • visual analogue scale

    Scale for assessement the degree of pain along 0-10 scale

    Change from 3 months after last injection and 6 months after last injection

  • measuring motor and sensory nerve conduction studies of median nerve using a standardized technique

    electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique

    Change from 3 months after last injection and 6 months after last injection

  • cross-sectional area (CSA) of the median nerve at the level of the pisiform.

    ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.

    Change from 3 months after last injection and 6 months after last injection

Study Arms (3)

PRP group

EXPERIMENTAL

patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals

Drug: platlet rich plasma (PRP)

Steroid group

ACTIVE COMPARATOR

patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals

Drug: Triamcinolone Acetonide

Control group

PLACEBO COMPARATOR

patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals

Drug: Saline

Interventions

platlet rich plasma (PRP)DRUG

Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.

PRP group
Triamcinolone AcetonideDRUG

40 mg triamcinolone acetonide

Steroid group
SalineDRUG

Saline

Control group

Eligibility Criteria

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

You may qualify if:

  • mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).

You may not qualify if:

  • Patients with severe or secondary type of CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, 31527, Egypt

Location

Related Publications (1)

  • Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.

    PMID: 26807124BACKGROUND

Related Links

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Triamcinolone AcetonideSodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 16, 2020

Study Start

February 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

EG(1)