Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome

NCT03863873 | Completed

• 1 other identifier: PRPCTS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate idiopathic carpal tunnel. They were randomly divided into two groups. Group 1: patients received ultrasound-guided platelet-rich plasma injection and group 2 patients received ultrasound-guided corticosteroid injection. The outcome measures were assessed via Visual Analogue Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor function of the median nerve and morphological changes of median nerve detected by ultrasound.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Platelet-rich plasma

Outcome Measures

Primary Outcomes (3)

• Pain improvement

  The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain.

  three months

• Function improvement

  The Boston CT Questionnaire (BCTQ) is a patient-based outcome measure that was designed specifically for CTS patients. BCTQ has 2 distinct scales, the Symptom Severity Scale (BCTQ-SSS) containing 11 questions and the Functional Status Scale (BCTQ-FSS) containing 8 items. All questions were rated for degree of difficulty on a 5points scale. Each scale producesa final average score (sum of the scores divided by number of items) with a higher score indicative of greater disability. The BCTQ was used as an outcome measure in clinical trials, and has been reported as a validity and reliable tool for assessment of CTS.

  three months

• Edema

  US examination of the m-CSA for all patients was performed using a 7-13 MHz linear array probe with a calibrated device (Siemens, Acuson P300 apparatus) on the same day of EDX examination and clinical evaluation. All US examinations were performed with the wrists at the neutral position. The US examiner applied a minimal pressure force to avoid induction of artificial nerve deformation. Three measurements of the m-CSA at the level of most-protuberant portion of the pisiform bone were performed. The mean of the three measurements is calculated.

  three months

Study Arms (2)

PRP Injection Group

ACTIVE COMPARATOR

PRP Preparation: 16 ml of blood was obtained from each patient using special PRP kits (GD medical pharma, Dutch company). The blood was collected on citrated tubes with a mixing ratio of 9:1 by volume. Tubes underwent 1st centrifugation at speed of 3000 rpm (704g) for 3 minutes (to separate red blood cells from plasma). Plasma was then removed by syringe and then placed into another sterile tube with no anticoagulant and then underwent 2nd centrifugation at speed of at 4000 rpm (1252g) for 15 min. The supernatant platelet-poor plasma was then removed leaving 2 ml of PRP pellets in the sediment, and suspend the PRP pellets by gentle shaking of the tube. PRP is activated by adding 200 μl of 0.025 calcium chloride(Dhurat and Sukesh, 2014).

Procedure: Platelet-Rich Plasma Injection Group

Steroid injection Group

ACTIVE COMPARATOR

A single injection of methylprednisolone acetate 40 mg/ml using a technique similar to that described for the PRP injection

Procedure: Platelet-Rich Plasma Injection Group

Interventions

Platelet-Rich Plasma Injection Group PROCEDURE

Platelet-Rich Plasma Injection Group

PRP Injection Group; Steroid injection Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild-to-moderate idiopathic CTS with clinical manifestations failed to respond to conservative treatment ( such as splint, medications, Physical therapy) for at least 3 months and they were diagnosed by electrophysiological study and musculoskeletal ultrasound.

You may not qualify if:

• Diabetes
• Hypothyroidism
• Rheumatoid arthritis
• Previous carpal tunnel decompressive surgery
• Cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome
• Previous corticosteroid injection into the carpal tunnel in the preceding 4 weeks
• Anemia (hemoglobin \<10gm%)
• Coagulopathy
• Pregnancy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Senna MK, Shaat RM, Ali AAA. Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome. Clin Rheumatol. 2019 Dec;38(12):3643-3654. doi: 10.1007/s10067-019-04719-7. Epub 2019 Aug 16.

  PMID: 31420812 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: March 5, 2019
• Study Start: July 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)