ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autonomic nervous system

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

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]

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]

Measurement of heart rate, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).

Timepoint [1]

Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling

Secondary outcome [1]

Measurement of breathing rate with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).

Timepoint [1]

Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling

Secondary outcome [2]

Measurement of skin conductance, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).

Timepoint [2]

Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling

Secondary outcome [3]

Measurement of skin temperature, with a multiparametric biofeedback: the NeXus 10 MK-II (Mind Media BV; Herten, the Netherlands).

Timepoint [3]

Baseline, continuous monitoring from needle application to needle removal, and 10 minutes after finishing the dry needling

Secondary outcome [4]

Measurement of salivary cortisol, with the Salivette (Registered Trademark) Cortisol.

Timepoint [4]

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

Sex

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

1/09/2016

Actual

17/11/2016

Date of last participant enrolment

Anticipated

Actual

8/02/2017

Date of last data collection

Anticipated

Actual

8/02/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Madrid

Funding & Sponsors

Funding source category [1]

University

Name [1]

Alcala Henares University

Address [1]

Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of research and animal experimentation of the University of Alcala

Ethics committee address [1]

Plaza de San Diego s/n
28801 Alcala de Henares (Madrid)

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

23/11/2015

Ethics approval number [1]

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

Miss Irene Lazaro Navas

Address

Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871

Country

Spain

Phone

+34699327333

Fax

irene_ln@hotmail.com

Contact person for public queries

Name

Irene Lazaro Navas

Address

Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871

Country

Spain

Phone

+34699327333

Fax

irene_ln@hotmail.com

Contact person for scientific queries

Name

Irene Lazaro Navas

Address

Physical Therapy Department, University of Alcala
Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares, 28871

Country

Spain

Phone

+34699327333

Fax

irene_ln@hotmail.com

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Immediate effects of dry needling on the autonomic nervous system and mechanical hyperalgesia: A randomized controlled trial.	2021	https://dx.doi.org/10.3390/ijerph18116018

N.B. These documents automatically identified may not have been verified by the study sponsor.

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