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

  • Clinicaltrials.gov identifier

    NCT04434105

  • Recruitment Status

    Active, not recruiting

  • First Posted

    June 16, 2020

  • Last update posted

    June 16, 2020

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.

  • Condition or Disease:Carpal Tunnel Syndrome
  • Intervention/Treatment: Drug: platlet rich plasma (PRP)
    Drug: Triamcinolone Acetonide
    Drug: Saline
  • Phase: Phase 2/Phase 3

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2020

Arms and interventions

Arm Intervention/treatment
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)
Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.
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
40 mg 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
Saline

Outcome Measures

  • Primary Outcome Measures: 1. visual analogue scale [ Time Frame: Change from 3 months after last injection and 6 months after last injection ]
    Scale for assessement the degree of pain along 0-10 scale
  • 2. 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 ]
    electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
  • 3. 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 ]
    ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.

Eligibility Criteria

  • Ages Eligible for Study: 20 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

Egypt
Tanta University Hospital
Tanta

Sponsors and Collaborators

Tanta University

More Information