Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome

NCT ID: NCT04434105

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PRP group

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

Group Type EXPERIMENTAL

platlet rich plasma (PRP)

Intervention Type DRUG

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

Steroid group

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

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

40 mg triamcinolone acetonide

Control group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline

Interventions

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platlet rich plasma (PRP)

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

Intervention Type DRUG

Triamcinolone Acetonide

40 mg triamcinolone acetonide

Intervention Type DRUG

Saline

Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with severe or secondary type of CTS
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hassan Abu-Zaid

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospital

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 26807124 (View on PubMed)

Related Links

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Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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