Menu
Recruiting NCT04636879

Dry Needling and Patients Treatment Expectations

No phase Interventional Neck Pain; Dry Needling; Motivation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point, Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point, Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point.
Who it may be relevant to
Registry conditions: Neck Pain; Dry Needling; Motivation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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).

Interventions

  • Other Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point
    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.
  • Other Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point
    The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding
  • Other Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point
    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 outcome measures

  • Skin conductance (µS). [Time frame: Change from baseline at twenty minutes]
Secondary outcome measures (3)
  • Heart rate variability [Time frame: Change from baseline at twenty minutes]
  • Pain intensity [Time frame: Change from baseline at twenty minutes]
  • Pressure pain threshold [Time frame: Change from baseline at twenty minutes.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Clinical University — Alcalá de Henares

Identifiers

NCT: NCT04636879 · CEI20/009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗