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

Phase 2

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: platlet rich plasma (PRP); Drug: Saline; Drug: Triamcinolone Acetonide

• Registration Number: NCT04434105
• Lead Sponsor: Tanta University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP group	platlet rich plasma (PRP)	patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals
Control group	Saline	patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals
Steroid group	Triamcinolone Acetonide	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

Primary Outcome Measures

Name	Time	Method
visual analogue scale	Change from 3 months after last injection and 6 months after last injection	Scale for assessement the degree of pain along 0-10 scale
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	electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
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	ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Egypt