Carpal TunnelPhase 1NCT04235426
Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
A Phase 1 study testing 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support., 30 patients went to surgical procedure and Injection in people with Carpal Tunnel, run by Dalia Salah Saif at 1 site in Egypt.
Trial summary
to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Carpal Tunnel
- What is being tested?
- 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support., 30 patients went to surgical procedure and Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2018to 31 Jan 2021
- Phase
- Phase 1
- 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
- patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.
Who cannot join
- pregnancy.
- history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
- history of local corticosteroid injection in the past 3 months.
- atrophy of thenar muscles.
- previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
- Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.
Trial locations and contacts
1 site in 1 country.
About this study
to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.
Read the detailed description
Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.
- Conditions
- Carpal Tunnel
- Being tested
- 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support., 30 patients went to surgical procedure, Injection
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.Drug
30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.
30 patients went to surgical procedureProcedure or surgery
30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.
InjectionOther
Also called PRP injection.
Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments
| Study group | Role | What they receive |
|---|---|---|
| surgical group. | Experimental | 30 patients went to the surgical release of carpal tunnel. Receives: Procedure: 30 patients went to surgical procedure |
| medical group. | Experimental | 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. Receives: Drug: 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. |
| injection group. | Experimental | Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments Receives: Other: Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analogue Scale),
The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Measured: at baseline and at 3 and 6 months post injection.
Electrophysiological study of median nerve.
motor and sensory conductive of the median nerve.
Measured: at baseline and at 3 and 6 months post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start26 Jan 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalia Salah Saif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Salah Saif, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235426
- Sponsor's protocol ID
- 1472
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
- ClinicalTrials.gov ID
- NCT04235426
- Acronym / sponsor ID
- 1472
- Conditions
- Carpal Tunnel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dalia Salah SaifUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 21 Jan 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.
to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.
Detailed description
Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgical group. | Experimental | Procedure: 30 patients went to surgical procedure30 patients went to the surgical release of carpal tunnel. |
| medical group. | Experimental | Drug: 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. |
| injection group. | Experimental | Other: InjectionThirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.
Key exclusion criteria (6 listed)
- pregnancy.
- history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
- history of local corticosteroid injection in the past 3 months.
- atrophy of thenar muscles.
- previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
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 |
|---|---|---|
| 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. | Drug | medical group. |
| 30 patients went to surgical procedure30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT. | Procedure or surgery | surgical group. |
| InjectionAlso: PRP injection.Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments | Other | injection group. |
Primary outcome
VAS (Visual Analogue Scale),
Time frame: at baseline and at 3 and 6 months post injection.
The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Electrophysiological study of median nerve.
Time frame: at baseline and at 3 and 6 months post injection.
motor and sensory conductive of the median nerve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Carpal Tunnel
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 1 study testing 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support., 30 patients went to surgical procedure and Injection in people with Carpal Tunnel, run by Dalia Salah Saif 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 6 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 22 Jan 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
VAS (Visual Analogue Scale), (time frame: at baseline and at 3 and 6 months post injection.). 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 22 Jan 2020.