Carpal Tunnel SyndromeNCT06399484
In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Nerve Mobilizations
A study testing Manual mobilizations of the median nerve and Wrist movements in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
This project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Manual mobilizations of the median nerve and Wrist movements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2024to 15 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years
- Present carpal tunnel syndrome diagnosed by electroneurogram
- Have understanding and communication skills
- Give consent to participate in the study
Who cannot join
- Have received previous surgery on the hand or wrist
- Present a severe limitation of movement in any of the joints of the affected upper limb
- Not signing the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Diego Rodríguez, 976765700, comunicacion3@salud.aragon.es
About this study
Official title: Immediate Effect of Median Nerve Mobilization on Neural Conduction in Patients With Carpal Tunnel Syndrome: Randomized Clinical Trial
This project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with carpal tunnel syndrome (CTS), resulting in the reading of 2 doctoral theses, the publication of 9 articles in high-impact journals. and the patent for a splint for the treatment of pathology. This project aims to provide information that is still lacking on the immediate effect of these techniques in patients with CTS. For this, there will be three groups of patients from the Lozano Blesa University Clinical Hospital distributed randomly. In two of the groups, sliding and neural tension techniques will be carried out (case group). The remaining group (control group) will be taken as a reference by performing a placebo treatment. Before and after carrying out these techniques, electrophysiological data will be collected to be able to compare them. This comparison is based on highlighting the differences between the data before the techniques and after, as well as between the case group and the control group.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Manual mobilizations of the median nerve, Wrist movements
- 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.
Manual mobilizations of the median nerveOther
Slippage of the median nerve in the wrist: the subject's starting position (P0) will be recumbent supine with the cervical spine in a neutral position, the shoulder girdle in neutral position, 30º of glenohumeral abduction in neutral rotation, 90º of elbow flexion, prone-supination of the neutral forearm, wrist and fingers in neutral position. From this position the movements will be 1) Glenohumeral abduction up to 90º; 2) Glenohumeral external rotation to the frontal plane; 3) Supination of the forearm; 4) Extension of the wrist and fingers; 5) Elbow extension. This position is will combine with an ipsilateral cervical inclination (distal sliding). The proximal slide is carried out bringing the fingers of the hand towards the flexion while performing a contralateral cervical tilt.
Median nerve tension: the starting position and movements are the same described above but this time it will be done with contralateral cervical tilt.
Wrist movementsOther
Movements of the wrist joint will be performed as a placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization group | Experimental | Manual mobilizations of the median nerve. Receives: Other: Manual mobilizations of the median nerve |
| Placebo group | Placebo comparator | wrist movements no producing sliding of the median nerve Receives: Other: Wrist movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal motor latency (APB) (ms)
Measured: Before and immediately after the intervention
Motor amplitude (APB) (mV)
Measured: Before and immediately after the intervention
Median motor velocity (m/s)
Measured: Before and immediately after the intervention
Median sensory conduction (digit II) (13 cm) (m/sec)
Measured: Before and immediately after the intervention
Sensory amplitude (µV)
Measured: Before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Dec 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, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Bueno Gracia, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399484
- Sponsor's protocol ID
- PI23/437
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Median Nerve Mobilization on Neural Conduction in Patients With Carpal Tunnel Syndrome: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06399484
- Acronym / sponsor ID
- PI23/437
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 May 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 project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with carpal tunnel syndrome (CTS), resulting in the reading of 2 doctoral theses, the publication of 9 articles in high-impact journals. and the patent for a splint for the treatment of pathology. This project aims to provide information that is still lacking on the immediate effect of these techniques in patients with CTS. For this, there will be three groups of patients from the Lozano Blesa University Clinical Hospital distributed randomly. In two of the groups, sliding and neural tension techniques will be carried out (case group). The remaining group (control group) will be taken as a reference by performing a placebo treatment. Before and after carrying out these techniques, electrophysiological data will be collected to be able to compare them. This comparison is based on highlighting the differences between the data before the techniques and after, as well as between the case group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization group | Experimental | Other: Manual mobilizations of the median nerveManual mobilizations of the median nerve. |
| Placebo group | Placebo comparator | Other: Wrist movementswrist movements no producing sliding of the median nerve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years
- Present carpal tunnel syndrome diagnosed by electroneurogram
- Have understanding and communication skills
- Give consent to participate in the study
Key exclusion criteria (3 listed)
- Have received previous surgery on the hand or wrist
- Present a severe limitation of movement in any of the joints of the affected upper limb
- Not signing the informed consent
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 |
|---|---|---|
| Manual mobilizations of the median nerveSlippage of the median nerve in the wrist: the subject's starting position (P0) will be recumbent supine with the cervical spine in a neutral position, the shoulder girdle in neutral position, 30º of glenohumeral abduction in neutral rotation, 90º of elbow flexion, prone-supination of the neutral forearm, wrist and fingers in neutral position. From this position the movements will be 1) Glenohumeral abduction up to 90º; 2) Glenohumeral external rotation to the frontal plane; 3) Supination of the forearm; 4) Extension of the wrist and fingers; 5) Elbow extension. This position is will combine with an ipsilateral cervical inclination (distal sliding). The proximal slide is carried out bringing the fingers of the hand towards the flexion while performing a contralateral cervical tilt. Median nerve tension: the starting position and movements are the same described above but this time it will be done with contralateral cervical tilt. | Other | Neural mobilization group |
| Wrist movementsMovements of the wrist joint will be performed as a placebo treatment | Other | Placebo group |
Primary outcome
Distal motor latency (APB) (ms)
Time frame: Before and immediately after the intervention
Motor amplitude (APB) (mV)
Time frame: Before and immediately after the intervention
Median motor velocity (m/s)
Time frame: Before and immediately after the intervention
Median sensory conduction (digit II) (13 cm) (m/sec)
Time frame: Before and immediately after the intervention
Sensory amplitude (µV)
Time frame: Before and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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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 Manual mobilizations of the median nerve and Wrist movements in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
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 4 inclusion and 3 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 3 May 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 Spain. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal motor latency (APB) (ms) (time frame: Before and immediately after the intervention). The study lists 5 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 3 May 2024.