Dry Needling for Treating Spasticity in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Dry Needling for Treating Spasticity in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351957
• Other study ID #: 2017_100
• Status: Completed
• Phase: N/A
• Start date: February 18, 2018
• Est. completion date: September 22, 2020

Study information

• Verified date: April 2022
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 22, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Dry needling
Only dry needling of the lower limbs will performed in all patients with acupunture needling

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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