Carpal Tunnel SyndromePhase 2/3NCT04434105
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome
A Phase 2/3 study testing platlet rich plasma (PRP), Triamcinolone Acetonide and Saline in people with Carpal Tunnel Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- platlet rich plasma (PRP), Triamcinolone Acetonide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to Dec 2020
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).
Who cannot join
- Patients with severe or secondary type of CTS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
Read the detailed description
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- platlet rich plasma (PRP), Triamcinolone Acetonide, Saline
- Keywords
- PRP injection, Local injection, 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.
platlet rich plasma (PRP)Drug
Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.
Triamcinolone AcetonideDrug
40 mg triamcinolone acetonide
SalineDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals Receives: Drug: platlet rich plasma (PRP) |
| Steroid group | Active comparator | patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals Receives: Drug: Triamcinolone Acetonide |
| Control group | Placebo comparator | patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Scale for assessement the degree of pain along 0-10 scale
Measured: Change from 3 months after last injection and 6 months after last injection
measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
Measured: Change from 3 months after last injection and 6 months after last injection
cross-sectional area (CSA) of the median nerve at the level of the pisiform.
ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.
Measured: Change from 3 months after last injection and 6 months after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Feb 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hassan Abu-Zaid, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434105
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
PubMed 26807124
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
- ClinicalTrials.gov ID
- NCT04434105
- Acronym / sponsor ID
- 001
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- PRP injection, Local injection, CTS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jun 2020 (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.
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
Detailed description
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Drug: platlet rich plasma (PRP)patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals |
| Steroid group | Active comparator | Drug: Triamcinolone Acetonidepatients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals |
| Control group | Placebo comparator | Drug: Salinepatients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).
Key exclusion criteria (1 listed)
- Patients with severe or secondary type of CTS
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 |
|---|---|---|
| platlet rich plasma (PRP)Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis. | Drug | PRP group |
| Triamcinolone Acetonide40 mg triamcinolone acetonide | Drug | Steroid group |
| SalineSaline | Drug | Control group |
Primary outcome
visual analogue scale
Time frame: Change from 3 months after last injection and 6 months after last injection
Scale for assessement the degree of pain along 0-10 scale
measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
Time frame: Change from 3 months after last injection and 6 months after last injection
electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
cross-sectional area (CSA) of the median nerve at the level of the pisiform.
Time frame: Change from 3 months after last injection and 6 months after last injection
ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 26807124Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
- effect of PRP on CTSLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing platlet rich plasma (PRP), Triamcinolone Acetonide and Saline in people with Carpal Tunnel Syndrome, run by Tanta 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 1 inclusion and 1 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 Jun 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
visual analogue scale (time frame: Change from 3 months after last injection and 6 months after last injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434105, which also lists 1 linked publication.
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 Jun 2020.