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Trial registered on ANZCTR


Registration number
ACTRN12616000881437
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
5/07/2016
Date last updated
9/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of dry needling on the autonomic nervous system function in healthy subjects: a randomized single blind clinical trial
Scientific title
The effects of dry needling on the autonomic nervous system function in healthy subjects: a randomized single blind clinical trial
Secondary ID [1] 289298 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autonomic nervous system 298885 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298959 298959 0 0
Physiotherapy
Neurological 299070 299070 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1:
Participants in Group 1 will receive one session of dry needling using the fast-in and fast-out technique described by Hong of the adductor pollicis muscle on the left hand.

- Materials: a felt-tip pen to mark the latent myofascial trigger point, alcohol, and disposable stainless-steel needles (0.3 × 30 mm; Novasan, S.A., Madrid, Spain)

- Procedures: Participants will be placed in a supine position on the examination table. The physiotherapist will locate and mark the latent myofascial trigger point of the adductor pollicis muscle on the left hand with a pincer palpation. Once the latent myofascial trigger point is located, the overlying skin will be cleaned with alcohol. The subject will put its forearm in a neutral pronosupination, and the needle will be inserted into the subject's skin over the palpated latent miofascial trigger point, from the dorsal zone to the palmar zone. The needle will be inserted so as to penetrate the skin 10 to 15 mm until a local twitch response is obtained. Once this response is obtained, the needle will be moved up and down (2- to 3-mm vertical motions with no rotations) 12 times at approximately 1 Hz. As soon as the needle is pulled out from the subject's skin, the physiotherapist will press firmly the region of the needle insertion for at least 2 minutes, to prevent excessive bleeding.

- Who: the intervention will be provided by a university professor expert in dry needling. The professor itself will make all the interventions.

- The study will be carried out in a conditioned room of Alcala de Henares University
Intervention code [1] 294850 0
Treatment: Other
Comparator / control treatment
The control treatment is Group 2

Participants in Group 2 will receive one session of sham dry needling of the adductor pollicis muscle on the left hand.

- Materials: a felt-tip pen to mark the latent myofascial trigger point and alcohol. In order to develop this technique, we will use Streitberger Placebo-needles.

- Procedures: Participants will be placed in a supine position on the examination table. The physiotherapist will locate and mark the latent myofascial trigger point of the adductor pollicis muscle on the left hand with a pincer palpation. Once the latent myofascial trigger point is located, the overlying skin will be cleaned with alcohol. Later, the physiotherapist will apply the ring at this point. Then, he will cover and fix the ring with plaster. (This material is included in Streitberger Placebo-needles). Finally, he will introduce the needle through the plaster inside the ring. As soon as the placebo needle touches the skin, the handle of the needle will have to be pushed over the needle. The movement of the needle will be repeated 12 times. After, the placebo needle will need to be removed quickly gripping it at the needle, not at the handle. Once, the placebo needle is removed, the physiotherapist will make pressure on the trigger point during 2 minutes as in Group 1.

- Who: the intervention will be provided by a university professor expert in dry needling. The professor itself will make all the interventions.

- The study will be carried out in a conditioned room of Alcala de Henares University
Control group
Placebo

Outcomes
Primary outcome [1] 298430 0
Measurement of heart rate, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).
Timepoint [1] 298430 0
Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling
Secondary outcome [1] 324101 0
Measurement of breathing rate with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).
Timepoint [1] 324101 0
Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling
Secondary outcome [2] 324102 0
Measurement of skin conductance, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).
Timepoint [2] 324102 0
Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling
Secondary outcome [3] 324103 0
Measurement of skin temperature, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).
Timepoint [3] 324103 0
Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling
Secondary outcome [4] 324104 0
Measurement of salivary cortisol, with the Salivette (Registered Trademark) Cortisol.
Timepoint [4] 324104 0
Baseline, and 3 minutes after finishing the dry needling.

Eligibility
Key inclusion criteria
Subjects need to be:
- Healthy
- Between 18 and 65 .
Subjects need to have:
- Latent myofascial trigger point at adductor pollicis muscle in left hand
- No pain
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they have a history of acute illness, malignancy, pregnancy, muscle disease, cognitive dysfunction, fibromyalgia, neurological disorders, metabolic disorders, fear of needles, and previous dry needling intervention in the last 6 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 7902 0
Spain
State/province [1] 7902 0
Madrid

Funding & Sponsors
Funding source category [1] 293677 0
University
Name [1] 293677 0
Alcala Henares University
Address [1] 293677 0
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871
Country [1] 293677 0
Spain
Primary sponsor type
University
Name
Alcala Henares University
Address
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871
Country
Spain
Secondary sponsor category [1] 292510 0
None
Name [1] 292510 0
None
Address [1] 292510 0
None
Country [1] 292510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295114 0
Ethics Committee of research and animal experimentation of the University of Alcala
Ethics committee address [1] 295114 0
Plaza de San Diego s/n
28801 Alcala de Henares (Madrid)
Ethics committee country [1] 295114 0
Spain
Date submitted for ethics approval [1] 295114 0
Approval date [1] 295114 0
23/11/2015
Ethics approval number [1] 295114 0
CEIT/HU/2015/06

Summary
Brief summary
Background: One of the possible analgesic mechanisms of the dry needling is the analgesia caused by stress, produced by the activation of the sympathetic nervous system. Although it is known that some techniques as acupuncture produce some changes in the autonomic nervous system, there is still a knowledge gap about the relation between dry needling and the autonomic nervous system.
Aim: To determine if the application of dry needling causes the activation of the sympathetic nervous system generating an analgesic effect by stress in healthy subjects.
Methodology: A single-blinded randomized controlled trial was performed at the University of Alcalá, involving a sample of 65 healthy volunteer subjects who accomplish the selection criteria, with an average age of 27,78 (DT = 8,41) years, within which the 50,8 per cent are men and the 49,2 per cent are women. The participants have been assigned by random to participate in group 1, to which a deep dry needling has been applied; or in group 2, to which a placebo needling technique has been applied. The intervention technique was applied in the adductor pollicis muscle of the left hand in both groups. In order to evaluate the sympathetic nervous system, the skin conductance, the heart rate, the heart rate variability, the skin temperature and the breathing rate prior have been measured, during and twice after the intervenction; with the biofeedback Nexus 10 MK-II equipment, as well as the salivary cortisol levels before and after the intervenction. The pressure pain threshold has been collected in the adductor pollicis muscle of the left hand and of the right tibialis anterior with a hand algometer, before and after the intervention. Moreover, the pain during the dry needling has been registered through a Verbal Numerical Scale of pain and the elicited local twitch responses.
Key words: Dry needling, Physiological Effects, Autonomic Nervous System.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66166 0
Miss Irene Lazaro Navas
Address 66166 0
Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871
Country 66166 0
Spain
Phone 66166 0
+34699327333
Fax 66166 0
Email 66166 0
irene_ln@hotmail.com
Contact person for public queries
Name 66167 0
Miss Irene Lazaro Navas
Address 66167 0
Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871
Country 66167 0
Spain
Phone 66167 0
+34699327333
Fax 66167 0
Email 66167 0
irene_ln@hotmail.com
Contact person for scientific queries
Name 66168 0
Miss Irene Lazaro Navas
Address 66168 0
Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871
Country 66168 0
Spain
Phone 66168 0
+34699327333
Fax 66168 0
Email 66168 0
irene_ln@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary