Carpal Tunnel SyndromePhase 4PRPNCT06249503
Ultrasound Guided Activated and Non Activated Platelet Rich Plasma Injection Versus Hydro Dissection by Steroids.
A Phase 4 study testing platelet rich plasma in people with Carpal Tunnel Syndrome and Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound, run by Ain Shams University at 1 site in Egypt.
Trial summary
PRP represents a promising, nonsurgical option for patients with carpal tunnel syndrome (CTS) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound
- What is being tested?
- platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with mild to moderate idiopathic Carpal Tunnel Syndrome with clinical manifestations, diagnosed by electrophysiological study and ultrasound. CTS grading will be performed on basis of an electrophysiological study following Stevens classification (Stevens; 1997).
- Early CTS: abnormal findings only in both comparative studies (≥0.5ms difference in peak latency)
- Mild CTS: abnormal median sensory study (peak latency ≥3.5ms)
- Moderate CTS: abnormal median sensory study and prolonged median distal motor latency (onset latency ≥4.5ms)
- Sever CTS: any of the above mentioned abnormalities together with the evidence of axonal loss either by absent median sensory response, low amplitude, or absent median motor response (<2µV)
Who cannot join
- • Patients suffering from diabetes, hypothyroidism, rheumatoid arthritis, , cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome, coagulopathy
- Pregnancy
- Previous corticosteroid injection into the carpal tunnel.
- Previous carpal tunnel decompressive surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Activated and Non-activated Platelet Rich Plasma Injection Versus Hydro Dissection for Treatment of Carpal Tunnel Syndrome
PRP represents a promising, nonsurgical option for patients with carpal tunnel syndrome (CTS) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. However, the lack of significant long-term results in pain and function demands the presence of future studies to further determine the long-term effect on a large group of homogeneous patients. More over to determine the clinical indications, effect on differing CTS severities, and the effects of preparation, concentration of the platelets and methods of activation of PRP
Read the detailed description
- The patients are blinded to the type of drug and the researchers are blinded to the randomization. Randomization will be done using a research randomization program (http://www.randomizer.org)
- Patients will be randomly divided into three groups; each consists of 30 patients. Group 1 will include patients subjected to ultrasound guided activated PRP injection, group 2 will include patients subjected to ultrasound guided non-activated PRP injection, and group 3 patients will be subjected to ultrasound guided hydro dissection using a combination of steroid (Triamcinolone 40mg), LA (local anesthesia) and dextrose.
- Conditions
- Carpal Tunnel Syndrome, Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound
- Being tested
- platelet rich plasma
- Keywords
- PRP, CTS
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
Also called PRP, steroids
The patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Activated PRP | Active comparator | PRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection. Receives: Drug: platelet rich plasma |
| Non-Activated PRP | Active comparator | PRP is used directly in hydrodissection. Receives: Drug: platelet rich plasma |
| Steroid group | Active comparator | Hydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose. Receives: Drug: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analogue scale
Ruler with number on it and the scale by measuring the distance in millimeter from 0 to 10 where is 0 means no pain and 10 means sever disabling pain and in between the different degrees of pain
Measured: 2 weeks,1,3 and 6 months
Secondary outcomes (1)
Boston Carpal Tunnel Syndrome Questionnaire
questionnaire formed of 11 questions each question give grading from 1 to 5 where is 1 means normal and 5 means sever pain and in between different grades
Measured: 2 weeks, 1,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona S Kamel, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249503
- Sponsor's protocol ID
- FMASU MD 154 2022
- Acronym
- PRP
- Status last verified
- May 2024
- First submitted
- 12 May 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Activated and Non-activated Platelet Rich Plasma Injection Versus Hydro Dissection for Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06249503
- Acronym / sponsor ID
- PRP / FMASU MD 154 2022
- Conditions
- Carpal Tunnel Syndrome, Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound
- Keywords
- PRP, CTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRP represents a promising, nonsurgical option for patients with carpal tunnel syndrome (CTS) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. However, the lack of significant long-term results in pain and function demands the presence of future studies to further determine the long-term effect on a large group of homogeneous patients. More over to determine the clinical indications, effect on differing CTS severities, and the effects of preparation, concentration of the platelets and methods of activation of PRP
Detailed description
- The patients are blinded to the type of drug and the researchers are blinded to the randomization. Randomization will be done using a research randomization program (http://www.randomizer.org)
- Patients will be randomly divided into three groups; each consists of 30 patients. Group 1 will include patients subjected to ultrasound guided activated PRP injection, group 2 will include patients subjected to ultrasound guided non-activated PRP injection, and group 3 patients will be subjected to ultrasound guided hydro dissection using a combination of steroid (Triamcinolone 40mg), LA (local anesthesia) and dextrose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Activated PRP | Active comparator | Drug: platelet rich plasmaPRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection. |
| Non-Activated PRP | Active comparator | Drug: platelet rich plasmaPRP is used directly in hydrodissection. |
| Steroid group | Active comparator | Drug: platelet rich plasmaHydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with mild to moderate idiopathic Carpal Tunnel Syndrome with clinical manifestations, diagnosed by electrophysiological study and ultrasound. CTS grading will be performed on basis of an electrophysiological study following Stevens classification (Stevens; 1997).
Key exclusion criteria (4 listed)
- • Patients suffering from diabetes, hypothyroidism, rheumatoid arthritis, , cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome, coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaAlso: PRP, steroidsThe patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve. | Drug | Activated PRP, Non-Activated PRP, Steroid group |
Primary outcome
Pain visual analogue scale
Time frame: 2 weeks,1,3 and 6 months
Ruler with number on it and the scale by measuring the distance in millimeter from 0 to 10 where is 0 means no pain and 10 means sever disabling pain and in between the different degrees of pain
1 secondary outcome
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 2 weeks, 1,3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona S Kamel principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing platelet rich plasma in people with Carpal Tunnel Syndrome and Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain visual analogue scale (time frame: 2 weeks,1,3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.