Dry Needling for Treating Spasticity in Multiple Sclerosis

NCT05351957 | Completed DMC

• 1 other identifier: 2017_100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Dry needling, multiple sclerosis, physiotherapy

Outcome Measures

Primary Outcomes (5)

• Change in 9HOLD PEG TEST score

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

  inmediatly before and inmediatly after intervention

• Change in 25 foot walk score

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

  inmediatly before and inmediatly after intervention

• Change in Time up and go test score

  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)

  inmediatly before and inmediatly after intervention

• Change in Expanded Disability Status Scale (EDSS) score

  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.

  inmediatly before and inmediatly after intervention

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

  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)

  inmediatly before and inmediatly after intervention

Study Arms (1)

dry needling

EXPERIMENTAL

This study has only 1 arm and the control group is their baseline data

Procedure: Dry needling

Interventions

Dry needling PROCEDURE

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

dry needling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Hospital Universitario de Canarias

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

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• MONSERRAT GONZÁLEZ-PLATAS

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 28, 2022
• Study Start: February 18, 2018
• Primary Completion: April 20, 2020
• Study Completion: September 22, 2020
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)