CClinicalTrials.gg
Status unknownNCT04434105Updated Jun 16, 2020

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

A Phase 2/3 interventional study of platlet rich plasma (PRP) and Triamcinolone Acetonide in Carpal Tunnel Syndrome, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2020, registered Jun 2020).
Phase
Phase 2/3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • PRP injection
  • Local injection
  • CTS
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with severe or secondary type of CTS
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    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

    Drug: platlet rich plasma (PRP)

  • Active comparator
    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

    Drug: Triamcinolone Acetonide

  • Placebo comparator
    Control group

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

    Drug: Saline

Interventions

  • Drugplatlet rich plasma (PRP)

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

  • DrugTriamcinolone Acetonide

    40 mg triamcinolone acetonide

  • DrugSaline

    Saline

06

What researchers measure

Primary outcomes

  1. visual analogue scale

    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

  2. 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

    Time frame: Change from 3 months after last injection and 6 months after last injection

  3. 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.

    Time frame: Change from 3 months after last injection and 6 months after last injection

07

Study locations

1 site
  • Tanta University Hospital
    Tanta, 31527, Egypt
08

References and documents

Publications

  • 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. PubMed 26807124 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04434105
Lead sponsor
Tanta University
Responsible party
Mohammed Hassan Abu-Zaid (principal investigator, Tanta University) — Principal investigator
First posted
Jun 16, 2020
Start date
Feb 1, 2020
Primary completion
Nov 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jun 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion