Dry Needling for Treating Spasticity in Multiple Sclerosis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dry needling

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Dry needling, multiple sclerosis, physiotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

Hospital Universitario de Canarias

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dry needling

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Change in 25 foot walk score

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

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

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05351957

First Posted

April 21, 2022

Last Updated

April 27, 2022

Sponsor

Hospital Universitario de Canarias

1. Study Identification

Unique Protocol Identification Number

NCT05351957

Brief Title

Dry Needling for Treating Spasticity in Multiple Sclerosis

Official Title

Dry Needling for Treating Spasticity in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

February 18, 2018 (Actual)

Primary Completion Date

April 20, 2020 (Actual)

Study Completion Date

September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario de Canarias

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Dry needling, multiple sclerosis, physiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dry needling

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Dry needling

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in 9HOLD PEG TEST score

Description

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

Time Frame