Carpal Tunnel SyndromeNCT02698085
Diacutaneous Fibrolysis on Carpal Tunnel Syndrome
A study testing Actual Diacutaneous Fibrolysis in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Actual Diacutaneous Fibrolysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2016to 10 Oct 2016
- 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
- Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)
Who cannot join
- Severe carpal tunnel syndrome
- Previous surgery on the hand
- hormonal factors: diabetes, thyroids pathologies, pregnant
- cervical disfunctions
- ulcerations or skins disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome
Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique.
The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a placebo.
Read more
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of carpal tunnel syndrome (low to moderate intensity) with a neurophysiological test.
Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the other placebo. Both groups receive 5 treatment sessions.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in placebo group, when the intervention finish the investigators will be given the opportunity to receive the actual technique
Read the detailed description
The investigators selected patients diagnosed with carpal tunnel syndrome with electroneurogram, if they meet the inclusion criteria are offered to take part in this study.
When the patient agree to participate and signed informed consent, the investigators collected dependent variables considered (symptoms, mechanosensitivity, functional capacity with upper limb, tractor speed of neural conduction ...) and the patient is assigned to an intervention group: real or placebo. Each patient receives treatment 5 sessions trascurriendo intersessional 2- 5 days. After 5 sessions the investigators remeasured the same variables. In addition, a month later they remeasured again symptoms and functional capacity with upper limb. Finally, they were shown the technique they have received. If the patient has received the technical placebo he/she is given the opportunity to receive 5 sessions of the actual technique.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Actual Diacutaneous Fibrolysis, Sham Diacutaneous Fibrolysis
- Keywords
- carpal tunnel syndrome, physiotherapy, manual therapy
- 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.
Actual Diacutaneous FibrolysisOther
Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.
Sham Diacutaneous FibrolysisOther
Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue
| Study group | Role | What they receive |
|---|---|---|
| Intervention Goup | Experimental | Actual Diacutaneous Fibrolysis Receives: Other: Actual Diacutaneous Fibrolysis |
| Placebo Group | Sham comparator | Sham Diacutaneous Fibrolysis Receives: Other: Sham Diacutaneous Fibrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity symptoms pre-intervention with a visual analogic scale
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Measured: pre-intervention
Intensity symptoms post-intervention with a visual analogic scale
The investigators measure the intensity of symptoms with a visual analogic scale at the end of the intervention (2 weeks after pre-intervention) the investigators measured the intensity of symptoms (through study completion, an average 15 days)
Measured: post-intervention
Intensity symptoms after month with a visual analogic scale
The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.
Measured: after month
Secondary outcomes (7)
Upper limb function pre-intervention with a validated questionnaire (DASH)
The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Measured: pre-intervention
Mechanosensitivity of median nerve pre-intervention with neurodynamic test
The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
Measured: Pre-intervention
Mechanosensitivity of median nerve post-intervention with neurodynamic test
The investigators measure the mechanosensitivity of median nerve with neurodynamic test at the end of the intervention (through study completion, an average 15 days).
Measured: post-intervention
Neurophysiological test pre-intervention
The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
Measured: pre-intervention
Neurophysiological test post-intervention
The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at the end of the intervention (through study completion, an average 15 days)
Measured: post-intervention
Upper limb function post-intervention with a validated questionnaire (DASH)
The investigators measure upper limb function with a validated questionnaire (DASH) at the end of the intervention (through study completion, an average 15 days)
Measured: post-intervention
Upper limb function after month with a validated questionnaire (DASH)
The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.
Measured: after month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Sep 2016
- Study completion10 Oct 2016
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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jiménez, Universidad de Zaragoza
- Investigators
- Sand J, Graduated, Principal investigator, I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698085
- Sponsor's protocol ID
- C.I.PI14/00086
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02698085
- Acronym / sponsor ID
- C.I.PI14/00086
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, physiotherapy, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Apr 2016
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique.
The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a placebo.
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of carpal tunnel syndrome (low to moderate intensity) with a neurophysiological test.
Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the other placebo. Both groups receive 5 treatment sessions.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in placebo group, when the intervention finish the investigators will be given the opportunity to receive the actual technique
Detailed description
The investigators selected patients diagnosed with carpal tunnel syndrome with electroneurogram, if they meet the inclusion criteria are offered to take part in this study.
When the patient agree to participate and signed informed consent, the investigators collected dependent variables considered (symptoms, mechanosensitivity, functional capacity with upper limb, tractor speed of neural conduction ...) and the patient is assigned to an intervention group: real or placebo. Each patient receives treatment 5 sessions trascurriendo intersessional 2- 5 days. After 5 sessions the investigators remeasured the same variables. In addition, a month later they remeasured again symptoms and functional capacity with upper limb. Finally, they were shown the technique they have received. If the patient has received the technical placebo he/she is given the opportunity to receive 5 sessions of the actual technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Goup | Experimental | Other: Actual Diacutaneous FibrolysisActual Diacutaneous Fibrolysis |
| Placebo Group | Sham comparator | Other: Sham Diacutaneous FibrolysisSham Diacutaneous Fibrolysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)
Key exclusion criteria (5 listed)
- Severe carpal tunnel syndrome
- Previous surgery on the hand
- hormonal factors: diabetes, thyroids pathologies, pregnant
- cervical disfunctions
- ulcerations or skins disorders
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 |
|---|---|---|
| Actual Diacutaneous FibrolysisDiacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes. | Other | Intervention Goup |
| Sham Diacutaneous FibrolysisSham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue | Other | Placebo Group |
Primary outcome
Intensity symptoms pre-intervention with a visual analogic scale
Time frame: pre-intervention
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Intensity symptoms post-intervention with a visual analogic scale
Time frame: post-intervention
The investigators measure the intensity of symptoms with a visual analogic scale at the end of the intervention (2 weeks after pre-intervention) the investigators measured the intensity of symptoms (through study completion, an average 15 days)
Intensity symptoms after month with a visual analogic scale
Time frame: after month
The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.
7 secondary outcomes
Upper limb function pre-intervention with a validated questionnaire (DASH)
Time frame: pre-intervention
Mechanosensitivity of median nerve pre-intervention with neurodynamic test
Time frame: Pre-intervention
Mechanosensitivity of median nerve post-intervention with neurodynamic test
Time frame: post-intervention
Neurophysiological test pre-intervention
Time frame: pre-intervention
Neurophysiological test post-intervention
Time frame: post-intervention
Upper limb function post-intervention with a validated questionnaire (DASH)
Time frame: post-intervention
Upper limb function after month with a validated questionnaire (DASH)
Time frame: after month
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 21 Nov 2017.
- Individual participant dataSharing planned: No. The patient data were confidential and were assigned a number to each patient to maintain confidentiality
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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.
Sand J, Graduated principal investigator
I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actual Diacutaneous Fibrolysis 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 1 inclusion and 5 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 21 Nov 2017. 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?
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?
Intensity symptoms pre-intervention with a visual analogic scale (time frame: pre-intervention). 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?
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 21 Nov 2017.