Cervical DystoniaTENDYSNCT04949594
Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
An observational study of Cervical Dystonia and Pain, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Dystonia is a chronic neurological condition that impacts the quality of life due to decreased mobility, social repercussions caused by others's perception of abnormal involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in reducing pain in dystonia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia, Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to 30 Jul 2020
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient admitted to a neurology consultation for cervical dystonia treated with botulinum toxin.
Who may be able to join
- Patient having received complete information on the organization of the research and not having objected to the exploitation of the data
- patient admitted to neurology consultation for cervical dystonia treated with botulinum toxin
Who cannot join
- Patient under legal protection
- Minor patient
- Patient refusing to give consent
- Patient with exclusive radicular or truncal involvement
- Missing data or absence of established reactogenic threshold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relief of Pain in Patients With Cervical Dystonia Through the Use of Sensory Threshold TENS
Dystonia is a chronic neurological condition that impacts the quality of life due to decreased mobility, social repercussions caused by others's perception of abnormal involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in reducing pain in dystonia. However, many patients remain painful despite the injections, especially when the decrease in the effect of the latter, performed every 3 months on average. Despite frequent use of TENS in pain relief, only a few small studies studying TENS in dystonia were published and none of them reported TENS effects on dystonic pain using sensory threshold.
This study aimed to quantify the efficacy and tolerance of TENS in the indication of pain related to dystonia, focusing on cervical dystonia which is the most common form of dystonia.
Read the detailed description
TENDYS (TENs use in cervical DYStonia) is an observational, prospective, single arm, monocentric study including subjects between September 2019 and July 2020 with cervical dystonia treated or not with botulinum neurotoxin (BoNT) type A at the Nancy Regional University Hospital.
All patients who benefited from a simple follow-up or injections of BoNT every 3 or 4 months for a painful cervical dystonia were proposed the use of TENS during a neurologic consultation with one of two specialist physicians trained to cervical dystonia. Patients who accepted had to give informed consent and were re-evaluated about 1 month later to ensure that pain persisted and to have a demo of TENS. The electro-stimulator was delivered to posterior cervical muscles over or close to the painful site, according to a Conventional or High frequency/Low intensity mode (Gate control). Patients were encouraged to use the machine daily, as often and long and possible, except for sleeping and driving.
Follow-up assessments of pain occurred at the consultation toxin injection 3 months later and at 4 months for all patients.
- Conditions
- Cervical Dystonia, Pain
- Being tested
- TENS
- Keywords
- cervical dystonia, pain, TENS
- Medical subject headings
- Torticollis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called transcutaneous electrical nerve stimulation
application on muscles where pain is situated (cervical)
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score
Toronto Western Spasmodic Torticollis Rating Scale (abbreviated TWSTRS) is a mixed clinician and patient rated cervical dystonia-specific scale. TWSTRS total score is scored from 0-85 (best to worst).
Measured: 3 months
Secondary outcomes (2)
Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Severity, -Disability and -Pain subscores
The TWSTRS is comprised of 3 subscales : severity (range 0-35), disability (range 0-30), and pain (range 0-20), each of which is scored independently (best to worst).
Measured: 3 months
Mean change of Pain Numeric Rating Scale score
Pain Numeric Rating Scale (abbreviated PNRS) is ranking 0-10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start21 Oct 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SOLENE FRISMAND-KRYLOFF, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949594
- Sponsor's protocol ID
- 2019PI213
- Acronym
- TENDYS
- Status last verified
- Oct 2021
- First submitted
- 25 Jun 2021
- Last updated
- 29 Oct 2021
- 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 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relief of Pain in Patients With Cervical Dystonia Through the Use of Sensory Threshold TENS
- ClinicalTrials.gov ID
- NCT04949594
- Acronym / sponsor ID
- TENDYS / 2019PI213
- Conditions
- Cervical Dystonia, Pain
- Keywords
- cervical dystonia, pain, TENS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 2 Jul 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.
Dystonia is a chronic neurological condition that impacts the quality of life due to decreased mobility, social repercussions caused by others's perception of abnormal involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in reducing pain in dystonia. However, many patients remain painful despite the injections, especially when the decrease in the effect of the latter, performed every 3 months on average. Despite frequent use of TENS in pain relief, only a few small studies studying TENS in dystonia were published and none of them reported TENS effects on dystonic pain using sensory threshold.
This study aimed to quantify the efficacy and tolerance of TENS in the indication of pain related to dystonia, focusing on cervical dystonia which is the most common form of dystonia.
Detailed description
TENDYS (TENs use in cervical DYStonia) is an observational, prospective, single arm, monocentric study including subjects between September 2019 and July 2020 with cervical dystonia treated or not with botulinum neurotoxin (BoNT) type A at the Nancy Regional University Hospital.
All patients who benefited from a simple follow-up or injections of BoNT every 3 or 4 months for a painful cervical dystonia were proposed the use of TENS during a neurologic consultation with one of two specialist physicians trained to cervical dystonia. Patients who accepted had to give informed consent and were re-evaluated about 1 month later to ensure that pain persisted and to have a demo of TENS. The electro-stimulator was delivered to posterior cervical muscles over or close to the painful site, according to a Conventional or High frequency/Low intensity mode (Gate control). Patients were encouraged to use the machine daily, as often and long and possible, except for sleeping and driving.
Follow-up assessments of pain occurred at the consultation toxin injection 3 months later and at 4 months for all patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient admitted to a neurology consultation for cervical dystonia treated with botulinum toxin.
Key inclusion criteria (2 listed)
- Patient having received complete information on the organization of the research and not having objected to the exploitation of the data
- patient admitted to neurology consultation for cervical dystonia treated with botulinum toxin
Key exclusion criteria (5 listed)
- Patient under legal protection
- Minor patient
- Patient refusing to give consent
- Patient with exclusive radicular or truncal involvement
- Missing data or absence of established reactogenic threshold
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 |
|---|---|---|
| TENSAlso: transcutaneous electrical nerve stimulationapplication on muscles where pain is situated (cervical) | Device | – |
Primary outcome
Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score
Time frame: 3 months
Toronto Western Spasmodic Torticollis Rating Scale (abbreviated TWSTRS) is a mixed clinician and patient rated cervical dystonia-specific scale. TWSTRS total score is scored from 0-85 (best to worst).
2 secondary outcomes
Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Severity, -Disability and -Pain subscores
Time frame: 3 months
Mean change of Pain Numeric Rating Scale score
Time frame: 3 months
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 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Cervical Dystonia
Enrolling by invitationPhase 2
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A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
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Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
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An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
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.
SOLENE FRISMAND-KRYLOFF principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia and Pain, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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 29 Oct 2021. 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 France. 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?
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?
Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score (time frame: 3 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 29 Oct 2021.