Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001070527p
Ethics application status
Submitted, not yet approved
Date submitted
15/06/2024
Date registered
4/09/2024
Date last updated
4/09/2024
Date data sharing statement initially provided
4/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Dry Needling in rigidity and gait in patients with Parkinson's Disease.
Scientific title
Effectiveness of Dry Needling in rigidity and gait in patients with Parkinson's Disease.
Secondary ID [1] 312328 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DNPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 334092 0
Rigidity 334093 0
Gait Disorders 334094 0
Pain 334095 0
Condition category
Condition code
Neurological 330768 330768 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 330769 330769 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 (50 mm if the muscle is deep, 40mm if the muscle is superficial), and applied by a physiotherapist. The technique of DN consists on the fast entry and exit of the needle in the Myofascial Trigger Point of the Rectus Femoris, Gastrocnemius Medialis muscle, Tibialis Anterior and Biceps Femoris, according to published application (1), until a minimum of 3-4 local twitch responses, always taking into account the tolerance of the patient, who will request to stop to the physiotherapist in any part of the process. The duration of each session is no more than 15 minutes. The intervention will be performed in the lower limb most affected by rigidity (which presents a rigidity measured by myotonometry and scored by Unified Parkinson’s Disease Rating Scale (UPDRS), in the target muscles).
A puncture will be made in each muscle per session, 1 session per week, for 3 weeks. Each intervention will be recoded in an "intervention notebook" in order to monitor adherence.
The intervention will be performed in the Parkinson´s Association of Seville, which it is an authorized health centre. 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)Espejo-Antúnez L, Tejeda JFH, Albornoz-Cabello M, Rodríguez-Mansilla J, de la Cruz-Torres B, Ribeiro F, et al. Dry needling in the management of myofascial trigger points: A systematic review of randomized controlled trials. Vol. 33, Complementary Therapies in Medicine Churchill Livingstone; 2017. p. 46–57.
Intervention code [1] 328831 0
Treatment: Other
Intervention code [2] 328832 0
Rehabilitation
Comparator / control treatment
Placebo group. For the placebo puncture, it will be used a Dong Bang placebo needle, which is very similar to the Streitberger needle. 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. The skin will be compressed for a total of 10 s. Patients experience a pressure sensation very similar to that of a normal needle.
Control group
Placebo

Outcomes
Primary outcome [1] 338548 0
Rigidity assessed by myotonometry.
Timepoint [1] 338548 0
Baseline and 3 weeks later commencement.
Primary outcome [2] 339289 0
Function of Gait, assessed by the number of steps and time employed in 3-Meter Backward Walk Test (3MBT) and by number of steps in The Figure-of-8 Walk Test.
Timepoint [2] 339289 0
Baseline and 3 weeks after commencement.
Secondary outcome [1] 436408 0
Muscle tone, assesed by surface electromyography (EMG).
Timepoint [1] 436408 0
Baseline and 3 weeks later commencement.
Secondary outcome [2] 436409 0
Motor function, assessed by part II and III of Unified Parkinson's Disease Rating Scale (UPDRS).
Timepoint [2] 436409 0
Baseline and 3 weeks later commencement.
Secondary outcome [3] 436412 0
Pain, assessed by algometry.
Timepoint [3] 436412 0
Baseline and 3 weeks after the commencent.
Secondary outcome [4] 439376 0
Fatigability and muscle recruitmente, assessed by electromyography.
Timepoint [4] 439376 0
Baseline and 3 weeks later.

Eligibility
Key inclusion criteria
Patients with a diagnosis of Parkinson's Disease.
Patients with 18 years-old and older.
Patients who can walk (with or without support), with a score minor than 4 at Hoenh and Yarh scale.
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
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with comorbidity which affects their gait.
Patients with needles fear.
Patients unable to adequately meet the requirements of the study for any reason, condition or cause, at the discretion of the researcher.
Patients with previous experiencia with dry-needling.
Patients who have had infiltrations with botulinum toxin in the lower limb in the last 3 months.
Patients who had participated in other Physical Therapy study in the last 6 months.
Patient with another neurological diagnosis.

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
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
1/10/2024
Actual
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
5/11/2024
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 26380 0
Spain
State/province [1] 26380 0
Sevilla

Funding & Sponsors
Funding source category [1] 316725 0
University
Name [1] 316725 0
University of Seville
Country [1] 316725 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Country
Spain
Secondary sponsor category [1] 318931 0
Charities/Societies/Foundations
Name [1] 318931 0
Asociación de Parkinson de Sevilla
Address [1] 318931 0
Country [1] 318931 0
Spain

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315500 0
Virgen Macarena Hospital Committee
Ethics committee address [1] 315500 0
Ethics committee country [1] 315500 0
Spain
Date submitted for ethics approval [1] 315500 0
15/07/2024
Approval date [1] 315500 0
Ethics approval number [1] 315500 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134894 0
Dr Carlos Luque-Moreno
Address 134894 0
Facultad de Enfermería, Fisioterapia y Podología. University of Seville. c/Avenzoar, 6, 41009, Sevilla.
Country 134894 0
Spain
Phone 134894 0
+34 954 55 79 06
Fax 134894 0
Email 134894 0
[email protected]
Contact person for public queries
Name 134895 0
Carlos Luque-Moreno
Address 134895 0
Facultad de Enfermería, Fisioterapia y Podología. University of Seville. c/Avenzoar, 6, 41009, Sevilla.
Country 134895 0
Spain
Phone 134895 0
+34 954 55 79 06
Fax 134895 0
Email 134895 0
[email protected]
Contact person for scientific queries
Name 134896 0
Carlos Luque-Moreno
Address 134896 0
Facultad de Enfermería, Fisioterapia y Podología. University of Seville. c/Avenzoar, 6, 41009, Sevilla.
Country 134896 0
Spain
Phone 134896 0
+34 954 55 79 06
Fax 134896 0
Email 134896 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.