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Trial registered on ANZCTR


Registration number
ACTRN12619000880145
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
20/06/2019
Date last updated
20/06/2019
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title

Effectiveness of dry needling in perceived pain, quality of gait and spasticity in patients with multiple sclerosis
Scientific title

Effectiveness of dry needling in perceived pain, quality of gait and spasticity in patients with multiple sclerosis
Secondary ID [1] 298290 0
"Nil known"
Universal Trial Number (UTN)
U1111-1233-7692
Trial acronym
DNMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 312916 0
Pain 313065 0
Gait Disorders 313066 0
Spasticity 313067 0
Condition category
Condition code
Neurological 311407 311407 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 311556 311556 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of Dry Needling (DN) using disposable stainless steel needles of 0.3 mm × 50 mm or 0.3 mm x 40 mm (Agupunt, Barcelona, Spain), depending on the depth of the muscle to be treated. The type of DN that will be used will be the technique of fast entry and exit of the needle in the Myofascial Trigger Point of the Rectus Femoris and Gastrocnemius Medialis muscles, according to a series of published diagnostic criteria (criteria of McDonald, 2010) and application guidelines [1], until a minimum of 3-4 local twitch responses, always taking into account the tolerance of the patient, who will be warned that in any part of the process ,can be directed to the physiotherapist to request stop. The intervention will be performed in the lower limb most affected by spasticity (which presents a higher Ashworth score in the target muscles).
A puncture will be made in each muscle per session, 1 session per week, for 2 weeks.
The intervention will be performed in a hospital environment. The duration of each dry needling session will be approximately 45-60 seconds for muscle, until the local twitch responses disappeared or until the patient could no longer bear the pain.
1. Tang L, Li Y, Huang Q-M, Yang Y. Dry needling at myofascial trigger points mitigates chronic post-stroke shoulder spasticity. [Internet]. Vol. 13, Neural regeneration research. 2018. p. 673-6.
Intervention code [1] 314526 0
Treatment: Other
Comparator / control treatment
Placebo group. For the placebo puncture, a simulation needle procedure using a Dong Bang placebo needle, which is very similar to the Streitberger needle, will be used. These needles represent an effective placebo technique for most subjects in studies using acupuncture. The physiotherapist will perform the same procedure with the real needle in DN to blind the subjects. These placebo needles cause a mechanical stimulation on the tissue without piercing the skin; Patients experience a pressure sensation very similar to that of a normal needle.
Control group
Placebo

Outcomes
Primary outcome [1] 320127 0
Pressure pain threshold in the puncture site of the Rectus Femoris muscle, measured by Algometry
Timepoint [1] 320127 0
Before the first intervention and a week after the second intervention.
Primary outcome [2] 320385 0
Pressure pain threshold in the puncture site of the Gastrocnemius muscle, measured by Algometry
Timepoint [2] 320385 0
Before the first intervention and a week after the second intervention.
Secondary outcome [1] 370653 0
Spasticity, measured using the Ashworth Modified Scale
Timepoint [1] 370653 0
Before the first intervention and a week after the second intervention.
Secondary outcome [2] 370654 0
Flexo-Extension angle of hip, measured by Goniometry
Timepoint [2] 370654 0
Before the first intervention and a week after the second intervention.
Secondary outcome [3] 371411 0
Flexo-Extension angle of knee, measured by Goniometry
Timepoint [3] 371411 0
Before the first intervention and a week after the second intervention.
Secondary outcome [4] 371412 0
Flexo-Extension angle of ankle, measured by Goniometry
Timepoint [4] 371412 0
Before the first intervention and a week after the second intervention.
Secondary outcome [5] 371413 0
Measurement of Maximum Voluntary Contraction (MVC) of the Rectus Femoris muscle, measured by Surface Electromyography
Timepoint [5] 371413 0
Before the first intervention and a week after the second intervention.
Secondary outcome [6] 371414 0
Measurement of Maximum Voluntary Contraction (MVC) of the Gastrocnemius Medialis, measured by Surface Electromyography
Timepoint [6] 371414 0
Before the first intervention and a week after the second intervention.
Secondary outcome [7] 371415 0
Measurement of Root Mean Square (RMS) of the Rectus Femoris muscle, measured by Surface Electromyography
Timepoint [7] 371415 0
Before the first intervention and a week after the second intervention.
Secondary outcome [8] 371416 0
Measurement of Root Mean Square (RMS) of the Gastrocnemius Medialis, measured by Surface Electromyography
Timepoint [8] 371416 0
Before the first intervention and a week after the second intervention.
Secondary outcome [9] 371417 0
Average Gait Speed measured using the GaitRite system
Timepoint [9] 371417 0
Before the first intervention and a week after the second intervention.
Secondary outcome [10] 371418 0
Walking Cadence, measured using the GaitRite system
Timepoint [10] 371418 0
Before the first intervention and a week after the second intervention.
Secondary outcome [11] 371421 0
Step Length, measured using the GaitRite system
Timepoint [11] 371421 0
Before the first intervention and a week after the second intervention.
Secondary outcome [12] 371422 0
Stride Length, measured using the GaitRite system
Timepoint [12] 371422 0
Before the first intervention and a week after the second intervention.
Secondary outcome [13] 371423 0
Step Width, measured using the GaitRite system
Timepoint [13] 371423 0
Before the first intervention and a week after the second intervention.
Secondary outcome [14] 371424 0
% Support-Oscillation, measured using the GaitRite system
Timepoint [14] 371424 0
Before the first intervention and a week after the second intervention.

Eligibility
Key inclusion criteria
Patients with a diagnosis of Multiple Sclerosis, according to the criteria of McDonald 2010.
Patients older than 18 years.
Patients who can walk (with or without support), with an EDSS score of 0-6.5.
Patients with stability of the disease, defined as absence of outbreaks in the previous month.
Patients who have signed the informed consent, show voluntariness to participate and can complete the scales and the protocol.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant patients
Patients with comorbidity or decompensated disease in the last month.
Patients who have received corticosteroid treatment in the last month.
Patients unable to adequately meet the requirements of the study for any reason, condition or cause, at the discretion of the researcher.
Patients who present some physical impediment to perform the walk test.
Patients who have had infiltrations with botulinum toxin in the lower limb in the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer by www.randomizer.org
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The experimental and the placebo group are composed by subjects with Multiple Sclerosis's diagnostic who respond to Inclusion's Criteria.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical Analysis is going to be performed by PASW STATISTIC 18 fr Window.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21512 0
Spain
State/province [1] 21512 0
Seville

Funding & Sponsors
Funding source category [1] 302834 0
Charities/Societies/Foundations
Name [1] 302834 0
DINAC (Foundation for the development of Research and assistance in Neurological and Related Chronic diseases)
Address [1] 302834 0
Sixth floor. Vithas Nisa Hospital.
Avda. Plácido Fernández Viagas. 41950 Castilleja de la Cuesta (Seville)
Country [1] 302834 0
Spain
Funding source category [2] 302926 0
University
Name [2] 302926 0
Departamento de Enfermería y Fisioterapia, Universidad de Cádiz
Address [2] 302926 0
Av. Ana de Viya, 52, 11009 Cádiz
Country [2] 302926 0
Spain
Primary sponsor type
University
Name
University of Cadiz
Address
Departamento de Enfermería y Fisioterapia.
Facultad de Enfermería y Fisioterapia.
Av. Ana de Viya, 52, 11009 Cádiz
Country
Spain
Secondary sponsor category [1] 302779 0
Charities/Societies/Foundations
Name [1] 302779 0
Fundación para el Desarrollo de la Investigación y Asistencia de las Enfermedades Neurológicas y Afines Crónicas Discapacitantes (DINAC).
Address [1] 302779 0
6 ª Planta Hospital Nisa Sevilla Aljarafe
Avda. Plácido Fernández Viagas, s/n
41950 Castilleja de la Cuesta (Sevilla)
Country [1] 302779 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303411 0
Comité de Ética de la Investigación Biomédica de Andalucía (CEI de los Hospitales Universitarios Virgen Macarena – Virgen del Rocío de Sevilla)
Ethics committee address [1] 303411 0
Hospital Universitario Virgen del Rocío
Avda. Manuel Siurot s/n
41013 - Seville
Ethics committee country [1] 303411 0
Spain
Date submitted for ethics approval [1] 303411 0
06/03/2019
Approval date [1] 303411 0
02/05/2019
Ethics approval number [1] 303411 0

Summary
Brief summary
Given the high prevalence of spasticity in Multiple Sclerosis and the functional limitations it causes in terms of pain and alteration of walking parameters, our study aims to give a non-pharmacological solution, through Physiotherapy to this problem. In particular, an intervention of Dry Puncture (PS) in two muscles (Recto Femoral and Medial Gastrocnemius), comparing the results with the obtained with the intervention of PS placebo in terms of perceived pain (algometry), walking functionality
(symmetry in spatio-temporal parameters and increase in the average speed of the march) and improvement of patterns electromyography, in a population of patients with MS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93582 0
Dr Carlos Luque-Moreno
Address 93582 0
Departamento de Enfermería y Fisioterapia
Facultad de Enfermería y Fisioterapia
Av. Ana de Viya, 52, 11009 Cádiz
Country 93582 0
Spain
Phone 93582 0
0034 956 01 90 00
Fax 93582 0
Email 93582 0
carlos.luque@uca.es
Contact person for public queries
Name 93583 0
Dr Carlos Luque-Moreno
Address 93583 0
Departamento de Enfermería y Fisioterapia
Facultad de Enfermería y Fisioterapia
Av. Ana de Viya, 52, 11009 Cádiz
Country 93583 0
Spain
Phone 93583 0
0034 956 01 90 00
Fax 93583 0
Email 93583 0
carlos.luque@uca.es
Contact person for scientific queries
Name 93584 0
Dr Carlos Luque-Moreno
Address 93584 0
Departamento de Enfermería y Fisioterapia
Facultad de Enfermería y Fisioterapia
Av. Ana de Viya, 52, 11009 Cádiz
Country 93584 0
Spain
Phone 93584 0
0034 956 01 90 00
Fax 93584 0
Email 93584 0
carlos.luque@uca.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results