Dry Needling and Patients Treatment Expectations

NCT ID: NCT04636879

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2025-09-05

Brief Summary

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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

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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).

Conditions

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Neck Pain; Dry Needling; Motivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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• 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."

Group Type EXPERIMENTAL

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

Intervention Type 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.

• Group 2. Neutral Expectation

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

• 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."

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

PhD. Daniel Pecos Martín

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Pecos-Martin, PhD

Role: STUDY_CHAIR

Alcala University

Locations

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Clinical University

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Daniel Pecos-Martín, PhD

Role: CONTACT

+ 34 918855142

Daniel Somkereki, Master

Role: CONTACT

636869373

Facility Contacts

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Patricia Martinez-Merinero, Dr

Role: primary

+34 918855142

Other Identifiers

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CEI20/009

Identifier Type: -

Identifier Source: org_study_id

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