Carpal Tunnel SyndromePhase 4NCT06209957
Study of Single Platelet-Rich Plasma Local Injection Vs. Single Corticosteroid Local Injection in Carpal Tunnel Syndrome
A Phase 4 study testing Local corticosteroid injection and Platelet-rich Plasma Local injection in people with Carpal Tunnel Syndrome, run by Menoufia University at 1 site in Egypt.
Trial summary
This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Local corticosteroid injection and Platelet-rich Plasma Local injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jan 2019
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild primary CTS complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. They are selected clinically and confirmed according to Padua's Neurophysiologic Severity Scale (PNSS) for CTS
Who cannot join
- Patients were excluded if they had moderate-to-severe NCS findings, space-occupying lesions within the carpal tunnel, traumatic CTS, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous CTS surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Platelet-Rich Plasma Injection vs. Corticosteroid Injection in Idiopathic Carpel Tunnel Syndrome
This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.
The main question[s] it aims to answer are:
Read more
- Does platelet-rich plasma injection provide better pain relief for CTS symptoms than steroid injection?
- Does platelet-rich plasma improve parameters of median nerve conduction study than local steroid?
Participants will have:
- A complete history and clinical examination, including sensory and motor examination and provocative tests for CTS.
- Visual analog scale (VAS), Symptom severity scale (SSS), and functional severity scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) before local injection and three months after local injection by the same investigator.
- Nerve conduction studies (NCS) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator.
Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.
There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded [5]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Local corticosteroid injection, Platelet-rich Plasma Local injection
- Keywords
- Carpal Tunnel Syndrome, Corticosteroids, Platelet-Rich Plasma, Nerve Conduction Study, Boston Questionnaire, Visual Analogue Scale
- 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.
Local corticosteroid injectionDrug
Local corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL
Platelet-rich Plasma Local injectionDrug
Platelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Local corticosteroid injection in group I: 1 ml of triamcinolone acetonide (40 milligram/1.0 mL) was locally injected in the wrist using a 25-gauge needle, which was slowly inserted 1 cm proximal to the distal wrist-flexion crease just on the radial side of the palmaris longus tendon. The injection was held if the patient experienced pain or a sensation of pins and needles in the median nerve distribution. Receives: Drug: Local corticosteroid injection |
| Group II | Active comparator | Local PRP injection in group II: 2 ml of PRP was injected using the same technique of corticosteroid local injection after 2-step centrifugation of the patient's blood using a specific device. Non-steroidal anti-inflammatory drugs were avoided for two weeks before and after the procedure to prevent the possibility of inhibition of platelet function. Receives: Drug: Platelet-rich Plasma Local injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Measured: before and after three months from injection time
Symptom severity scale of the Boston Carpal Tunnel Questionnaire
Pain severity evaluation
Measured: before and after three months from injection time
Functional severity scale of the Boston Carpal Tunnel Questionnaire
Hand function evaluation
Measured: before and after three months from injection time
Median nerve sensory peak latency
Sensory conduction evaluation of median nerve
Measured: before and after three months from injection time
Median nerve distal motor latency
Motor conduction evaluation of the median nerve.
Measured: before and after three months from injection time
Median nerve sensory amplitude
Sensory conduction evaluation of the median nerve
Measured: before and after three months from injection time
Median nerve motor amplitude
Motor conduction evaluation of the median nerve.
Measured: before and after three months from injection time
Median nerve sensory conduction velocity
Sensory conduction evaluation of the median nerve
Measured: before and after three months from injection time
Median nerve motor conduction velocity
Motor conduction evaluation of the median nerve.
Measured: before and after three months from injection time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jun 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, interventional, comparative double-blinded study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Allam, Menoufia University
- Investigators
- Saga F El-Gazzar, Study director, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209957
- Sponsor's protocol ID
- PRP in CTS
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient enrollment started June 2017 to early January 2019
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet-Rich Plasma Injection vs. Corticosteroid Injection in Idiopathic Carpel Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06209957
- Acronym / sponsor ID
- PRP in CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Corticosteroids, Platelet-Rich Plasma, Nerve Conduction Study, Boston Questionnaire, Visual Analogue Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Jan 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.
This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.
The main question[s] it aims to answer are:
- Does platelet-rich plasma injection provide better pain relief for CTS symptoms than steroid injection?
- Does platelet-rich plasma improve parameters of median nerve conduction study than local steroid?
Participants will have:
- A complete history and clinical examination, including sensory and motor examination and provocative tests for CTS.
- Visual analog scale (VAS), Symptom severity scale (SSS), and functional severity scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) before local injection and three months after local injection by the same investigator.
- Nerve conduction studies (NCS) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator.
Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.
Detailed description
Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.
There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded [5]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, interventional, comparative double-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Local corticosteroid injectionLocal corticosteroid injection in group I: 1 ml of triamcinolone acetonide (40 milligram/1.0 mL) was locally injected in the wrist using a 25-gauge needle, which was slowly inserted 1 cm proximal to the distal wrist-flexion crease just on the radial side of the palmaris longus tendon. The injection was held if the patient experienced pain or a sensation of pins and needles in the median nerve distribution. |
| Group II | Active comparator | Drug: Platelet-rich Plasma Local injectionLocal PRP injection in group II: 2 ml of PRP was injected using the same technique of corticosteroid local injection after 2-step centrifugation of the patient's blood using a specific device. Non-steroidal anti-inflammatory drugs were avoided for two weeks before and after the procedure to prevent the possibility of inhibition of platelet function. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild primary CTS complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. They are selected clinically and confirmed according to Padua's Neurophysiologic Severity Scale (PNSS) for CTS
Key exclusion criteria (1 listed)
- Patients were excluded if they had moderate-to-severe NCS findings, space-occupying lesions within the carpal tunnel, traumatic CTS, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous CTS surgery.
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 |
|---|---|---|
| Local corticosteroid injectionLocal corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL | Drug | Group I |
| Platelet-rich Plasma Local injectionPlatelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection. | Drug | Group II |
Primary outcome
Visual analog scale
Time frame: before and after three months from injection time
The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Symptom severity scale of the Boston Carpal Tunnel Questionnaire
Time frame: before and after three months from injection time
Pain severity evaluation
Functional severity scale of the Boston Carpal Tunnel Questionnaire
Time frame: before and after three months from injection time
Hand function evaluation
Median nerve sensory peak latency
Time frame: before and after three months from injection time
Sensory conduction evaluation of median nerve
Median nerve distal motor latency
Time frame: before and after three months from injection time
Motor conduction evaluation of the median nerve.
Median nerve sensory amplitude
Time frame: before and after three months from injection time
Sensory conduction evaluation of the median nerve
Median nerve motor amplitude
Time frame: before and after three months from injection time
Motor conduction evaluation of the median nerve.
Median nerve sensory conduction velocity
Time frame: before and after three months from injection time
Sensory conduction evaluation of the median nerve
Median nerve motor conduction velocity
Time frame: before and after three months from injection time
Motor conduction evaluation of the median nerve.
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 18 Jan 2024.
- Individual participant dataSharing planned: No. Patient enrollment started June 2017 to early January 2019
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Recruiting
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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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.
Saga F El-Gazzar study director
Menoufia 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 Local corticosteroid injection and Platelet-rich Plasma Local injection in people with Carpal Tunnel Syndrome, run by Menoufia 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: finished, as of the sponsor's last update on 18 Jan 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.
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?
Visual analog scale (time frame: before and after three months from injection time). The study lists 9 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 18 Jan 2024.