CClinicalTrials.gg
Status unknownNCT04235426Updated Jan 22, 2020

Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.

A Phase 1 interventional study of 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. and 30 patients went to surgical procedure in Carpal Tunnel, sponsored by Dalia Salah Saif. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Dalia Salah Saif · Phase 1, Interventional, and Treatment

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this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2018, registered Jan 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.

Read the detailed description

Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.

02

Conditions studied

  • Carpal Tunnel
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

Dalia Salah Saif is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

  • patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.

Exclusion criteria

Exclusion Criteria:

  1. pregnancy.
  2. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
  3. history of local corticosteroid injection in the past 3 months.
  4. atrophy of thenar muscles.
  5. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
  6. Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    surgical group.

    30 patients went to the surgical release of carpal tunnel.

    Procedure: 30 patients went to surgical procedure

  • Experimental
    medical group.

    30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

    Drug: 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

  • Experimental
    injection group.

    Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments

    Other: Injection

Interventions

  • Drug30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

    30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

  • Procedure30 patients went to surgical procedure

    30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.

  • OtherInjection

    Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments

    Also known as: PRP injection.

06

What researchers measure

Primary outcomes

  1. VAS (Visual Analogue Scale),

    The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)

    Time frame: at baseline and at 3 and 6 months post injection.

  2. Electrophysiological study of median nerve.

    motor and sensory conductive of the median nerve.

    Time frame: at baseline and at 3 and 6 months post injection.

07

Study locations

1 site
  • Dalia Saif
    Cairo, 11311, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04235426
Lead sponsor
Dalia Salah Saif
Responsible party
Dalia Salah Saif (principle investigator, Menoufia University) — Sponsor-investigator
First posted
Jan 21, 2020
Start date
Jan 26, 2018
Primary completion
Jan 31, 2021 (estimated)
Completion
Jan 31, 2021 (estimated)
Last update
Jan 22, 2020

Oversight

Data monitoring committee
Yes
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 Jan 2020. You cannot join it, but the record below documents what was studied.

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