NCT04235426

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 17, 2020

Last Update Submit

January 18, 2020

Conditions

Carpal Tunnel

Outcome Measures

Primary Outcomes (2)

  • VAS (Visual Analogue Scale),

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

    at baseline and at 3 and 6 months post injection.

  • Electrophysiological study of median nerve.

    motor and sensory conductive of the median nerve.

    at baseline and at 3 and 6 months post injection.

Study Arms (3)

surgical group.

EXPERIMENTAL

30 patients went to the surgical release of carpal tunnel.

Procedure: 30 patients went to surgical procedure

medical group.

EXPERIMENTAL

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.

injection group.

EXPERIMENTAL

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

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.

medical group.
30 patients went to surgical procedurePROCEDURE

30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.

surgical group.
InjectionOTHER

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.
injection group.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnancy.
  • history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
  • history of local corticosteroid injection in the past 3 months.
  • atrophy of thenar muscles.
  • previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalia Saif

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Median Neuropathy

Interventions

Anti-Inflammatory Agents, Non-SteroidalDiclofenacInjections

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 21, 2020

Study Start

January 26, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

EG(1)