- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863873
Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intervention:
PRP Injection Group(PRP-inj-G) - This group included 49 patients (40 females and 9 males). Their age ranged from 20 to 60 years.
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).
Ultrasound-Guided Injection: Proper preparation with an antiseptic solution of skin overlying the point of injection was performed guided by ultrasonography (Siemens Acuson P300 machine). With the palm facing upward and the wrist joint in slight extension, the MN will be recognized at the inlet of the CT(Wu et al., 2017). The injection was guided by ultrasound with the use of the ulnar in-plane technique(Lee et al., 2014). Ulnar artery was identified by the means of Doppler imaging, and a 25-gauge needle was introduced from the ulnar side of the wrist between CT and MN. Then the entire CT was scanned to confirm that the injection had dispersed through the proximal to the distal area of the CT. All patients were observed for 30 minutes post-injection for the possibility of dysesthesia or bleeding(Wu et al., 2017).
PRP injection: A 25-gauge needle was gently introduced one cm proximal to the distal wrist-flexion crease just to the ulnar side of the palmaris longus tendon and 2 ml of PRP was injected into the CT.
Steroid injection Group(St-inj-G) - included 49 patients (41 females and 8 males)with their age ranged from 20 to 60 years. A single injection of methylprednisolone acetate 40 mg/ml using a technique similar to that described for the PRP injection
Post-injection care for both groups:
- Some patients may have minimal to moderate discomfort after injection. So, to control pain, patients should apply ice on the injection site and also modify activity as tolerated.
- Rest for one day.
- The patient immediately returns to work two days after injection.
- Pain medication in the form of paracetamol only was allowed for the next 3 months if needed. The patients were instructed to stop analgesics 48 hours before the visit to allow proper symptoms assessment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mansoura, Egypt, 35516
- Mansoura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PRP Injection Group
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).
|
Platelet-Rich Plasma Injection Group
|
Active Comparator: Steroid injection Group
A single injection of methylprednisolone acetate 40 mg/ml using a technique similar to that described for the PRP injection
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Platelet-Rich Plasma Injection Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain improvement
Time Frame: three months
|
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.
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three months
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Function improvement
Time Frame: three months
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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.
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three months
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Edema
Time Frame: three months
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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.
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three months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRPCTS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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