Carpal Tunnel SyndromeNCT06368505
Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
A study testing ultrasound guided PRP injection and ultrasound guided hydrodissection in people with Carpal Tunnel Syndrome, run by Osama Ahmed Elshafei at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- ultrasound guided PRP injection and ultrasound guided hydrodissection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2024to 16 Jul 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed clinically as carpal tunnel syndrome with at least 3 months of symptoms and confirmed electro-physiologically as carpal tunnel syndrome
Who cannot join
- Onset of carpal tunnel syndrome during pregnancy
- Co-existence of brachial plexopathy or thoracic outlet syndrome by clinical examination
- Previous carpal tunnel decompressive surgery or corticosteroid injection in carpal tunnel
- Patients with infection or local edema at the site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, 35511
osama elshafei, MD PHD, osama_elshafei@mans.edu.eg
Dena El-Ghzzawy, Profdr_os@yahoo.com
About this study
Official title: A Prospective Comparative Study on the Efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:
- Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
- Asses safety profile of both methods
Participants will:
- Randomized to one of the two arms
- Visit the clinic 1 and 3 months after intervention
- Assessed for efficacy and safety of the intervention
Read the detailed description
The medical records of patients diagnosed with carpal tunnel syndrome will be reviewed using a computerized carpal tunnel syndrome sheet including all variables for each patient assessing the symptoms and the functional condition by assessing changes in the usual daily routines. The assessment of the patients was done before and after the intervention (1 and 3 months later).
The CSA is obtained (in mm² at distal wrist crease) using ultrasound. Then the CTS grading was determined via US staging 9-13, 13-15, \>15 as mild, moderate and severe respectively.
Ultrasound-Guided Intracarpal Injection. High-resolution US examination will be done by using a GE Logiq E9 with ML6-15-D Matrix linear array probe (USA). Under sterile conditions, a 25-gauge needle will be used using ulnar approach and under real time visualization the needle will be guided to the superficial ulnar aspect of the median nerve. The patients will be randomized into two groups
PRP group:
whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach
Hydrodissection group:
5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL.
All patients will be observed for 30-min post-injection for possible side effects before discharge.
Outcome Measurements: All outcome assessments will be measured at 1 and 3 months after intervention.
Primary Outcome Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and The visual analog scale (VAS) to assess the efficacy of interventions Secondary Outcome The cross-sectional area (CSA) of the Median nerve will be measured by the same US machine, Measurements were repeated 3 times and averaged for further
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- ultrasound guided PRP injection, ultrasound guided hydrodissection
- Keywords
- carpal tunnel, ultrasound guided intervention
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided PRP injectionOther
whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach
ultrasound guided hydrodissectionOther
5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma | Experimental | 3 ml PRP injection Receives: Other: ultrasound guided PRP injection |
| hydrodissection | Experimental | 5ml injectate Receives: Other: ultrasound guided hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a patient-based questionnaire, consists of two main scales:
Symptom Severity Scale (SSS): Measures the severity of symptoms related to CTS. Functional Status Scale (FSS): Assesses functional limitations caused by CTS. Each scale contains several items, and patients rate their symptoms or functional difficulties on a scale from 1 to 5.
A score of 1 indicates no symptoms or functional difficulty. A score of 5 represents maximum symptoms or inability to perform the task1.
Interpretation:
Higher scores on both scales indicate worse symptoms or greater functional impairment due to CTS.
Measured: before the intervention,1 and 3 months after intervention
The visual analog scale (VAS)
The Visual Analogue Scale (VAS) is a simple assessment tool used to measure pain intensity.
The VAS consists of a straight horizontal line, usually 10 centimetres (cm) in length.
One end of the line represents "no pain," while the other end represents "the worst pain ever experienced." Patients are asked to rate their current level of pain by placing a mark on the line.
Using a ruler, the score is determined by measuring the distance (in millimetres) from the "no pain" anchor to the patient's mark.
The resulting score ranges from 0 to 100, with a higher score indicating greater pain intensity.
Measured: before the intervention,1 and 3 months after intervention
Secondary outcomes (1)
The cross-sectional area (CSA) of the Median nerve
Using the ultrasound, the CSA is obtained (in mm² at distal wrist crease) by utilizing the tracing function on the US machine by direct tracing around the inner margin of the epineurium but with no weaving in between each fascicle. Measurements were repeated three times and average value was used for statistical evaluation.
Measured: before the intervention and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start16 Jan 2024
- Primary completion16 Jun 2024 (estimated)
- Study completion16 Jul 2024 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osama Ahmed Elshafei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osama Ahmed Elshafei, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368505
- Sponsor's protocol ID
- R.24.02.2506.R1
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study on the Efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06368505
- Acronym / sponsor ID
- R.24.02.2506.R1
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel, ultrasound guided intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Osama Ahmed ElshafeiUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 16 Jul 2024 (estimated)
- First posted
- 16 Apr 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.
The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:
- Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
- Asses safety profile of both methods
Participants will:
- Randomized to one of the two arms
- Visit the clinic 1 and 3 months after intervention
- Assessed for efficacy and safety of the intervention
Detailed description
The medical records of patients diagnosed with carpal tunnel syndrome will be reviewed using a computerized carpal tunnel syndrome sheet including all variables for each patient assessing the symptoms and the functional condition by assessing changes in the usual daily routines. The assessment of the patients was done before and after the intervention (1 and 3 months later).
The CSA is obtained (in mm² at distal wrist crease) using ultrasound. Then the CTS grading was determined via US staging 9-13, 13-15, \>15 as mild, moderate and severe respectively.
Ultrasound-Guided Intracarpal Injection. High-resolution US examination will be done by using a GE Logiq E9 with ML6-15-D Matrix linear array probe (USA). Under sterile conditions, a 25-gauge needle will be used using ulnar approach and under real time visualization the needle will be guided to the superficial ulnar aspect of the median nerve. The patients will be randomized into two groups
PRP group:
whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach
Hydrodissection group:
5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL.
All patients will be observed for 30-min post-injection for possible side effects before discharge.
Outcome Measurements: All outcome assessments will be measured at 1 and 3 months after intervention.
Primary Outcome Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and The visual analog scale (VAS) to assess the efficacy of interventions Secondary Outcome The cross-sectional area (CSA) of the Median nerve will be measured by the same US machine, Measurements were repeated 3 times and averaged for further
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma | Experimental | Other: ultrasound guided PRP injection3 ml PRP injection |
| hydrodissection | Experimental | Other: ultrasound guided hydrodissection5ml injectate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed clinically as carpal tunnel syndrome with at least 3 months of symptoms and confirmed electro-physiologically as carpal tunnel syndrome
Key exclusion criteria (4 listed)
- Onset of carpal tunnel syndrome during pregnancy
- Co-existence of brachial plexopathy or thoracic outlet syndrome by clinical examination
- Previous carpal tunnel decompressive surgery or corticosteroid injection in carpal tunnel
- Patients with infection or local edema at the site of injection.
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 |
|---|---|---|
| ultrasound guided PRP injectionwhole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach | Other | Platelet rich plasma |
| ultrasound guided hydrodissection5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL | Other | hydrodissection |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: before the intervention,1 and 3 months after intervention
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a patient-based questionnaire, consists of two main scales: Symptom Severity Scale (SSS): Measures the severity of symptoms related to CTS. Functional Status Scale (FSS): Assesses functional limitations caused by CTS. Each scale contains several items, and patients rate their symptoms or functional difficulties on a scale from 1 to 5. A score of 1 indicates no symptoms or functional difficulty. A score of 5 represents maximum symptoms or inability to perform the task1. Interpretation: Higher scores on both scales indicate worse symptoms or greater functional impairment due to CTS.
The visual analog scale (VAS)
Time frame: before the intervention,1 and 3 months after intervention
The Visual Analogue Scale (VAS) is a simple assessment tool used to measure pain intensity. The VAS consists of a straight horizontal line, usually 10 centimetres (cm) in length. One end of the line represents "no pain," while the other end represents "the worst pain ever experienced." Patients are asked to rate their current level of pain by placing a mark on the line. Using a ruler, the score is determined by measuring the distance (in millimetres) from the "no pain" anchor to the patient's mark. The resulting score ranges from 0 to 100, with a higher score indicating greater pain intensity.
1 secondary outcome
The cross-sectional area (CSA) of the Median nerve
Time frame: before the intervention and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided PRP injection and ultrasound guided hydrodissection in people with Carpal Tunnel Syndrome, run by Osama Ahmed Elshafei 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 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact osama elshafei, MD, PHD (+201211182182, osama_elshafei@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) (time frame: before the intervention,1 and 3 months after intervention). The study lists 2 primary outcomes in all. 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 2024; AzTrials last refreshed its copy on 7 Nov 2026.