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Completed

NCT Number: NCT04949594

Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (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.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Frismand-Kryloff

Nancy, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

TENS

Device

application on muscles where pain is situated (cervical)

Other names: transcutaneous electrical nerve stimulation

Primary outcomes

  1. 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).

Secondary outcomes

  1. Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Severity, -Disability and -Pain subscores

    Time frame: 3 months

    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).

  2. Mean change of Pain Numeric Rating Scale score

    Time frame: 3 months

    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".

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Relief of Pain in Patients With Cervical Dystonia Through the Use of Sensory Threshold TENS

Acronym: TENDYS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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