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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Procedure: Dry needling

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2018
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Dry needling, multiple sclerosis, physiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2017_100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No