Carpal Tunnel SyndromeNCT04762238
Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
A study testing Diacutaneous Fibrolysis in people with Carpal Tunnel Syndrome and Physical Therapy Modalities, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible to all clinicians. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasonography
- What is being tested?
- Diacutaneous Fibrolysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2021to 10 Jul 2021
- 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
The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible to all clinicians. In this way ultrasounds (US) is a more accessible and economical tool and many studies have reported that US has high sensitivity and specificity in the diagnosis of CTS.Diacutaneous Fibrolysis (DF) is a physiotherapeutic technique derived from Cyriax deep friction massage principles.DF technique could assist in improving changes in the connective tissues adjacent to the median nerve, especially the thickness of TCL and this could be reflected in a decreasing of TCL. Moreover, the neurophysiological and mechanical effect described by this technique may improve the nerve compression decreasing the CSA of the median nerve.
The purpose of this study is to quantify changes in the cross-sectional area of the median nerve in the carpal tunnel and the thickness of transversal carpal ligament measured by US and the changes in the intensity of the numbness and the subjective assessment of clinical change after DF treatment in forearm, wrist and hand area compared to placebo.
- Being tested
- Diacutaneous Fibrolysis
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Actual Diacutaneous Fibrolysis | Experimental | 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. Receives: Other: Diacutaneous Fibrolysis |
| Sham Diacutaneous Fibrolysis | Sham comparator | 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 Receives: Other: Diacutaneous Fibrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area of the median nerve with ultrasonography
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Measured: Baseline (Before the treatment)
Cross sectional area of the median nerve with ultrasonography
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Measured: After treatment application, an average of 2 weeks
Secondary outcomes (5)
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Intensity of numbness with Visual Analogue Scale (1-10cm)
Measured: Baseline (Before the treatment)
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Intensity of numbness with Visual Analogue Scale (1-10cm)
Measured: After treatment application, an average of 2 weeks
Thicknesses of transverse carpal ligament with ultrasonography
the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level
Measured: Baseline (Before the treatment)
Thicknesses of transverse carpal ligament with ultrasonography
the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level
Measured: After treatment application, an average of 2 weeks
Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)
Subjective assessment of clinical change with Global Rating of Change Scale (GROC scale) a scale ranging from -7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better").
Measured: After treatment application, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Feb 2021
- Primary completion20 May 2021
- Study completion10 Jul 2021
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
- Sandra Jiménez-del-Barrio, PhD, Principal investigator, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762238
- Sponsor's protocol ID
- University of Zaragoza
- Status last verified
- Jan 2022
- First submitted
- 10 Feb 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
- ClinicalTrials.gov ID
- NCT04762238
- Acronym / sponsor ID
- University of Zaragoza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 21 Feb 2021 (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.
The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible to all clinicians. In this way ultrasounds (US) is a more accessible and economical tool and many studies have reported that US has high sensitivity and specificity in the diagnosis of CTS.Diacutaneous Fibrolysis (DF) is a physiotherapeutic technique derived from Cyriax deep friction massage principles.DF technique could assist in improving changes in the connective tissues adjacent to the median nerve, especially the thickness of TCL and this could be reflected in a decreasing of TCL. Moreover, the neurophysiological and mechanical effect described by this technique may improve the nerve compression decreasing the CSA of the median nerve.
The purpose of this study is to quantify changes in the cross-sectional area of the median nerve in the carpal tunnel and the thickness of transversal carpal ligament measured by US and the changes in the intensity of the numbness and the subjective assessment of clinical change after DF treatment in forearm, wrist and hand area compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual Diacutaneous Fibrolysis | Experimental | Other: 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. |
| Sham Diacutaneous Fibrolysis | Sham comparator | Other: 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 |
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 |
|---|---|---|
| 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 | Actual Diacutaneous Fibrolysis, Sham Diacutaneous Fibrolysis |
Primary outcome
Cross sectional area of the median nerve with ultrasonography
Time frame: Baseline (Before the treatment)
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Cross sectional area of the median nerve with ultrasonography
Time frame: After treatment application, an average of 2 weeks
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
5 secondary outcomes
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Time frame: Baseline (Before the treatment)
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Time frame: After treatment application, an average of 2 weeks
Thicknesses of transverse carpal ligament with ultrasonography
Time frame: Baseline (Before the treatment)
Thicknesses of transverse carpal ligament with ultrasonography
Time frame: After treatment application, an average of 2 weeks
Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)
Time frame: After treatment application, an average of 2 weeks
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 2022.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
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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.
Sandra Jiménez-del-Barrio, PhD principal investigator
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous Fibrolysis in people with Carpal Tunnel Syndrome and Physical Therapy Modalities, 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 18 Jan 2022. 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?
Cross sectional area of the median nerve with ultrasonography (time frame: Baseline (Before the treatment)). 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 18 Jan 2022.