Dry Needling and Patients Treatment Expectations

Sponsor
University of Alcala (Other)
Overall Status
Recruiting
CT.gov ID
NCT04636879
Collaborator
(none)
45
1
3
26.3
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point
  • Other: Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point
  • Other: Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Feb 23, 2021
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
May 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: • Group 1. Positive expectation

"Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain."

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.

Active Comparator: • Group 2. Neutral Expectation

"Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown".

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

Active Comparator: • Group 3. Negative Expectation

"Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit."

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

Outcome Measures

Primary Outcome Measures

  1. Skin conductance (µS). [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 Outcome Measures

  1. Pain intensity [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.

  2. Pressure pain threshold [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).

  3. Heart rate variability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical University Alcala de Henares Madrid Spain 2805

Sponsors and Collaborators

  • University of Alcala

Investigators

  • Study Chair: Daniel Pecos-Martin, PhD, Alcala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Daniel Pecos Martín, PhD. Daniel Pecos Martín, University of Alcala
ClinicalTrials.gov Identifier:
NCT04636879
Other Study ID Numbers:
  • CEI20/009
First Posted:
Nov 19, 2020
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022