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Completed

NCT Number: NCT05351957

Dry Needling for Treating Spasticity in Multiple Sclerosis

The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded Disability Sta- tus Scale) greater than 2.5 points (related with pyramidal score) were recruited. DN was performed in lower limbs for 12 consecutive sessions and evaluated with: EDSS (Pyramidal item), Time up and go (TUG), 25 foot, 9hold peg test (9HPT) and the improvement or not in the quality of life (MSQol54) was verified before and after treatment. A follow up visit was carried out to assess improvement.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being a patient diagnosed with multiple sclerosis.
  • Being over 18 years of age and less than or equal to 60 years of age.
  • Having a score equal to or greater than 2 in the EDSS.
  • They need to have a measurement in the following functional systems: P (pyramidal) >2, CT (brainstem), gait >2 and sphincter >2.
  • They need to present hypertonia or contractures of the muscles selected for the dry needling, the pain expressed by the patients must be a consequence of spastic processes, have hourly availability to receive therapies and not have needle phobias.

Exclusion criteria

  • Having a disease associated with multiple sclerosis that is incompatible with dry needling.
  • Being in relapse, or having suffered it in the thirty days prior to starting the treatment. program or taking medications that are contraindicated with the technique applied in the study, (oral anticoagulants.)

Treatment and study plan

dry needling

Procedure

Only dry needling of the lower limbs will performed in all patients with acupunture needling

Primary outcomes

  1. Change in 9HOLD PEG TEST score

    Time frame: inmediatly before and inmediatly after intervention

    This consists of placing the pegs in the corresponding holes of the 9 holes in the table in the shortest possible time (seconds)

  2. Change in 25 foot walk score

    Time frame: inmediatly before and inmediatly after intervention

    patients must walk a distance of 7.25 meters at the fastest and safest speed for them (seconds)

  3. Change in Time up and go test score

    Time frame: inmediatly before and inmediatly after intervention

    The participants sit in a chair with their backs supported by the back of the chair and their arms resting on the armrests. The participants are asked to get up from the chair and walk a distance of 3 meters, then the patients turn on themselves (360°), walk back to the chair and sit down again (seconds)

  4. Change in Expanded Disability Status Scale (EDSS) score

    Time frame: inmediatly before and inmediatly after intervention

    Each item is valued individually and a score is given, which will then outline the patient's total EDSS ranging from 0 to 10, for use in the exploration sessions. All scans were carried out by a blind explorer.

  5. Change in Multiple sclerosis Quality of life-54 (MSQol54) score

    Time frame: inmediatly before and inmediatly after intervention

    questionnaire of 54 items measuring the quality of life of the patient. It can be self-administered or hetero-administered and both physical and mental aspects are measured. Within these there are subscales: among them quality of life in general. Two summary scores, physical health and mental health, can be derived from a weighted combination of scale scores. They range from 0 to 100, where 100 is the highest quality of life (both for physical and mental health)

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2022
Registry last updated
Apr 28, 2022

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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