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

Carpal Tunnel Syndrome Clinical Trial

Official title:

Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04434105
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• 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.
• Triamcinolone Acetonide
40 mg triamcinolone acetonide
• Saline
Saline

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   effect of PRP on CTS