Dry Needling for Treating Spasticity in Multiple Sclerosis

Sponsor

Hospital Universitario de Canarias (Other)

Overall Status

Completed

CT.gov ID

NCT05351957

Collaborator

(none)

Enrollment

Location

Arm

31.1

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Procedure: Dry needling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dry Needling for Treating Spasticity in Multiple Sclerosis

Actual Study Start Date :

Feb 18, 2018

Actual Primary Completion Date :

Apr 20, 2020

Actual Study Completion Date :

Sep 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dry needling This study has only 1 arm and the control group is their baseline data	Procedure: Dry needling Only dry needling of the lower limbs will performed in all patients with acupunture needling

Arm

Intervention/Treatment

Experimental: dry needling

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

Procedure: Dry needling

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

Outcome Measures

Primary Outcome Measures

Change in 9HOLD PEG TEST score [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)
Change in 25 foot walk score [inmediatly before and inmediatly after intervention]
patients must walk a distance of 7.25 meters at the fastest and safest speed for them (seconds)
Change in Time up and go test score [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)
Change in Expanded Disability Status Scale (EDSS) score [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.
Change in Multiple sclerosis Quality of life-54 (MSQol54) score [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife	Spain	38320

Sponsors and Collaborators

Hospital Universitario de Canarias

Investigators

Study Director: MONSERRAT GONZÁLEZ-PLATAS, Hospital Universitario de Canarias

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alberto Javier Ormazábal, Physiotherapist, Hospital Universitario de Canarias

ClinicalTrials.gov Identifier:

NCT05351957

Other Study ID Numbers:

2017_100

First Posted:

Apr 28, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alberto Javier Ormazábal, Physiotherapist, Hospital Universitario de Canarias

Dry needling, multiple sclerosis, physiotherapy

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Apr 28, 2022