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NCT Number: NCT04636879

Dry Needling and Patients Treatment Expectations

Objectives The aim of this study is to compare the effects of inducing positive expectations against negative or neutral induced expectations on the activation of the Autonomic Nervous System and the analgesic response, after a dry needling technique in upper trapezius fibers in patients with unspecific neck pain.

Summary Theoretical framework: Dry needling has proven its efficacy for the treatment of myofascial trigger points. Moreover, it has proven its effects over the Central Nervous System and the Autonomic Nervous System (ANS). Despite that previous studies have researched the role of patient's expectations and their relationship with the results of treatment, there is insufficient information concerning the effects of inducing expectations and the activation of the ANS during the application of widely used therapies, such as dry needling.

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Key information

Conditions

Neck Pain; Dry Needling; Motivation Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical University

Alcalá de Henares, Madrid, 2805, Spain

Location status: Recruiting

Location contact

Patricia Martinez-Merinero, Dr

CONTACT

[email protected]

+34 918855142

About this study

The aim of this study will be to research the effects of induced expectations combined with a dry needling technique on the activation of the ANS and on the results of the treatment.

Hypothesis: The induction of a positive expectation shall cause a greater analgesic response associated with a response in the ANS compared to the induction of neutral or negative expectations.

Methods: Patients with neck pain will participated in this randomized clinical trial, which will be randomly assigned into 3 groups in order to receive positive, neutral or negative expectations concerning the treatment, by means of an individual informative talk. All subjects will received treatment using dry needling in the upper trapezius fibers. The main variables measured will be the following: Analogic Visual Scale, Pressure Pain Threshold using a mechanical Force Gage (before and after) and the activation of the ANS measuring the skin conductance, skin temperature, heart rate and breathing rate (monitored for 5 minutes before the intervention, during and 20 minutes afterwards).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neck pain.
  • Hiperalgesic point in Upper trapezius muscle.

Exclusion criteria

  • Pain Irradiation toward upper limb
  • Psychological disorders
  • Whiplash.
  • Neuropathic symptoms
  • Cervical and / or Shoulder Spine Surgery

Treatment and study plan

Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point

Other

The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding message.

Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point

Other

The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding

Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point

Other

The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding

Primary outcomes

  1. Skin conductance (µS).

    Time frame: Change from baseline at twenty minutes

    It is the measure of the variations in the electrical resistance of the skin, caused by the excitation of the sweat glands, controlled by the Sympathetic Nervous System (SNS)

Secondary outcomes

  1. Heart rate variability

    Time frame: Change from baseline at twenty minutes

    This variable is defined as the variation of the heartbeat in a previously defined period in an analysis of consecutive circadian periods. It measures the time in milliseconds between the R waves of two consecutive beats (known as the RR interval) and is widely used in the field of Cardiology for the stratification of patients after an acute myocardial infarction. It has also been shown to be a useful tool in detecting ANS activation.

  2. Pain intensity

    Time frame: Change from baseline at twenty minutes

    It will be collected through the Visual Analogue Scale (VAS). It is a continuous scale, which consists of a 100 mm horizontal straight line, so that zero is equivalent to "total absence of pain" and 100 to "more bearable pain.

  3. Pressure pain threshold

    Time frame: Change from baseline at twenty minutes.

    The pressure pain threshold is defined as the minimum amount of pressure necessary to cause pain. It has been measured through a Force Dial FDK using a mechanical Force Gage (Wagner Instruments).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Pecos-Martín, PhD

CONTACT

[email protected]

+ 34 918855142

Daniel Somkereki, Master

CONTACT

[email protected]

636869373

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Influence of Induced Expectations on the Autonomic Nervous System During a Dry Needling Intervention for Patients With Neck Pain. A Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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