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

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
platlet rich plasma (PRP)
Triamcinolone Acetonide
Saline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring PRP injection, Local injection, CTS

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

PRP group

Steroid group

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 14, 2020
Last Updated
June 15, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04434105
Brief Title
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome
Official Title
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
PRP injection, Local injection, CTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals
Arm Title
Steroid group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals
Intervention Type
Drug
Intervention Name(s)
platlet rich plasma (PRP)
Intervention Description
Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
40 mg triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline
Primary Outcome Measure Information:
Title
visual analogue scale
Description
Scale for assessement the degree of pain along 0-10 scale
Time Frame
Change from 3 months after last injection and 6 months after last injection
Title
measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
Description
electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
Time Frame
Change from 3 months after last injection and 6 months after last injection
Title
cross-sectional area (CSA) of the median nerve at the level of the pisiform.
Description
ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.
Time Frame
Change from 3 months after last injection and 6 months after last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26807124
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705801/
Description
effect of PRP on CTS

Learn more about this trial

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

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