Carpal Tunnel SyndromeNCT06016049
Cerebral Changes Following CTS Treated With Guided Plasticity
A study testing EMLA® adjuvant and Sensory training in people with Carpal Tunnel Syndrome, run by Region Skane.
Trial summary
70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- EMLA® adjuvant and Sensory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2009to 1 Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptoms of CTS for more than 3 months
- classic or probable CTS according to Katz' hand diagram (2, 27)
- clinical signs of unilateral CTS with a positive Tinel's and Phalen's test
- age between 18 and 70 years
- nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side
- no contraindications for MR examinations.
Who cannot join
- bilateral symptoms
- having been operated for CTS previously
- prior wrist or carpal fracture
- diabetes
- thyroid disease
- rheumatoid arthritis
Show all 9Show fewer
- neurological disease
- drug abuse
- complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.
About this study
Official title: Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity
70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- EMLA® adjuvant, Sensory training
- Keywords
- Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand
- 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.
EMLA® adjuvantOther
cutaneous forearm deafferentation
Sensory trainingBehavioural
Sensibility training of the median nerve
| Study group | Role | What they receive |
|---|---|---|
| EMLA® | Active comparator | adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity Receives: Other: EMLA® adjuvant; Behavioral: Sensory training |
| Skin cream | Placebo comparator | skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training Receives: Behavioral: Sensory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Symptom Severity Score
score between 1 and 5, with higher scores indicating worse symptoms or function
Measured: 8 weeks
functional MRI activation affected vs healthy side (more activation voxels means more active brain area)
The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)
Measured: 8 weeks
Secondary outcomes (6)
quick-DASH upper extremity symptom score
score between 1-5, higher scores indicating less symptoms
Measured: 8 weeks
2 Point Discrimination (2PD)
mean value of 3 measures indicating touch threshold
Measured: 8 weeks
Sensory conduction velocity
Sensory Nerve Conduction Velocity from nerve conduction studies
Measured: 8 weeks
Sensory conduction amplitude
Sensory Nerve Conduction Amplitude from nerve conduction studies
Measured: 8 weeks
functional MRI dig 1+2
comparison between activation using interaction contrast in S1sensory cortex of the
Measured: 8 weeks
functional MRI dig 5
comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jul 2009
- Primary completion1 Nov 2015
- Study completion1 Nov 2015
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Flondell, MD PhD, Principal investigator, Institute of Translational Sciences Malmö, Lund UniversityAnders Björkman, MD, Prof., Study chair, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016049
- Sponsor's protocol ID
- 210817
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data can be shared upon reasonable demand after personal contact.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity
- ClinicalTrials.gov ID
- NCT06016049
- Acronym / sponsor ID
- 210817
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 29 Aug 2023 (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.
70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA® | Active comparator | Other: EMLA® adjuvant, Behavioral: Sensory trainingadjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity |
| Skin cream | Placebo comparator | Behavioral: Sensory trainingskin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- symptoms of CTS for more than 3 months
- classic or probable CTS according to Katz' hand diagram (2, 27)
- clinical signs of unilateral CTS with a positive Tinel's and Phalen's test
- age between 18 and 70 years
- nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side
Key exclusion criteria (9 listed)
- bilateral symptoms
- having been operated for CTS previously
- prior wrist or carpal fracture
- diabetes
- thyroid disease
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 |
|---|---|---|
| EMLA® adjuvantcutaneous forearm deafferentation | Other | EMLA® |
| Sensory trainingSensibility training of the median nerve | Behavioural | EMLA®, Skin cream |
Primary outcome
Boston Carpal Tunnel Syndrome Symptom Severity Score
Time frame: 8 weeks
score between 1 and 5, with higher scores indicating worse symptoms or function
functional MRI activation affected vs healthy side (more activation voxels means more active brain area)
Time frame: 8 weeks
The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)
6 secondary outcomes
quick-DASH upper extremity symptom score
Time frame: 8 weeks
2 Point Discrimination (2PD)
Time frame: 8 weeks
Sensory conduction velocity
Time frame: 8 weeks
Sensory conduction amplitude
Time frame: 8 weeks
functional MRI dig 1+2
Time frame: 8 weeks
functional MRI dig 5
Time frame: 8 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 29 Aug 2023.
- Individual participant dataSharing planned: No. data can be shared upon reasonable demand after personal contact.
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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.
Magnus Flondell, MD PhD principal investigator
Institute of Translational Sciences Malmö, Lund University
Anders Björkman, MD, Prof. study chair
Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University
Questions about this trial
What is this clinical trial studying?
A study testing EMLA® adjuvant and Sensory training in people with Carpal Tunnel Syndrome, run by Region Skane.
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 6 inclusion and 9 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Boston Carpal Tunnel Syndrome Symptom Severity Score (time frame: 8 weeks). 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 29 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.