Neuropathic PainNCT04058041
Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome
A study testing Neural Mobilization, Surgery and Surgery and neural mobilization in people with Neuropathic Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
neural exercise in patients with carpal tunnel syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Neural Mobilization, Surgery and Surgery and neural mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2018to 20 Sep 2020
- 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
- Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve
Who cannot join
- Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Josué Fernández, PhD, 34914888949, josue.fernandez@urjc.com
About this study
Official title: Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome
neural exercise in patients with carpal tunnel syndrome
Read the detailed description
OBJECTIVE: The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.
STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.
METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.
- Conditions
- Neuropathic Pain
- Being tested
- Neural Mobilization, Surgery, Surgery and neural mobilization
- Keywords
- Neural mobilization, Surgery, Pain modulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural MobilizationProcedure or surgery
neural exercise Will be performed in the patients
SurgeryProcedure or surgery
open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome
Surgery and neural mobilizationProcedure or surgery
following the surgery patients will be treat with neural mobilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization | Experimental | passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand Receives: Procedure: Surgery; Procedure: Surgery and neural mobilization |
| Surgery | Active comparator | the surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients. Receives: Procedure: Neural Mobilization; Procedure: Surgery and neural mobilization |
| Surgery and Neural mobilization | Active comparator | the surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group. Receives: Procedure: Neural Mobilization; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameter
Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test
Measured: Change from Baseline Conditioned pain modulation at 6 months
Secondary outcomes (13)
Neuropathic pain
Neuropathic pain Questionnaire DN4
Measured: Baseline and 6 months
Pain intensity
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: Baseline and 6 months
Pain expansion
Body pain maps
Measured: Change from baseline and 6 months
Pressure pain threshold
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Measured: Baseline and 6 months
Psychological factors_Anxiety
State Trait Anxiety Inventory (STAI-T)
Measured: Baseline and 6 months
Psychological factors_Depression
Beck Depression Inventory (BDI-II)
Measured: Baseline and 6 months
Psychological factors_Kinesiophobia
Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome.
Measured: Baseline and 6 months
Psychological factors_catastrophizing
Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome.
Measured: Baseline and 6 months
Psychological factors_Fear avoidance
Fear Avoidance Belief Questionnaire (FABQ)
Measured: Baseline and 6 months
Disability_DASH
Disabilities of Arm, Shoulder and Hand (DASH)
Measured: Baseline and 6 months
Disability_BOSTON
Boston Carpal Tunnel Questionnaire
Measured: Baseline and 6 months
Strength_grip
grip strength without pain
Measured: Baseline and 6 months
Strength_pinch
pinch strength
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start12 Mar 2018
- Primary completion12 Feb 2020 (estimated)
- Study completion20 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058041
- Sponsor's protocol ID
- CPMP/ICH/135/95
- Status last verified
- Aug 2019
- First submitted
- 13 Feb 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04058041
- Acronym / sponsor ID
- CPMP/ICH/135/95
- Conditions
- Neuropathic Pain
- Keywords
- Neural mobilization, Surgery, Pain modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 12 Feb 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 15 Aug 2019 (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.
neural exercise in patients with carpal tunnel syndrome
Detailed description
OBJECTIVE: The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.
STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.
METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization | Experimental | Procedure: Surgery, Procedure: Surgery and neural mobilizationpassive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand |
| Surgery | Active comparator | Procedure: Neural Mobilization, Procedure: Surgery and neural mobilizationthe surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients. |
| Surgery and Neural mobilization | Active comparator | Procedure: Neural Mobilization, Procedure: Surgerythe surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve
Key exclusion criteria (1 listed)
- Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy
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 |
|---|---|---|
| Neural Mobilizationneural exercise Will be performed in the patients | Procedure or surgery | Surgery, Surgery and Neural mobilization |
| Surgeryopen or endoscopic surgery will be permed in the patients with tunnel carpal syndrome | Procedure or surgery | Neural mobilization, Surgery and Neural mobilization |
| Surgery and neural mobilizationfollowing the surgery patients will be treat with neural mobilization exercises. | Procedure or surgery | Neural mobilization, Surgery |
Primary outcome
Physiological parameter
Time frame: Change from Baseline Conditioned pain modulation at 6 months
Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test
13 secondary outcomes
Neuropathic pain
Time frame: Baseline and 6 months
Pain intensity
Time frame: Baseline and 6 months
Pain expansion
Time frame: Change from baseline and 6 months
Pressure pain threshold
Time frame: Baseline and 6 months
Psychological factors_Anxiety
Time frame: Baseline and 6 months
Psychological factors_Depression
Time frame: Baseline and 6 months
Psychological factors_Kinesiophobia
Time frame: Baseline and 6 months
Psychological factors_catastrophizing
Time frame: Baseline and 6 months
Psychological factors_Fear avoidance
Time frame: Baseline and 6 months
Disability_DASH
Time frame: Baseline and 6 months
Disability_BOSTON
Time frame: Baseline and 6 months
Strength_grip
Time frame: Baseline and 6 months
Strength_pinch
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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 Neural Mobilization, Surgery and Surgery and neural mobilization in people with Neuropathic Pain, run by Universidad Rey Juan Carlos 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 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 15 Aug 2019. 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. 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 Josué Fernández, PhD (34914888949, josue.fernandez@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter (time frame: Change from Baseline Conditioned pain modulation at 6 months). 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 15 Aug 2019.