Dry Needling and Patients Treatment Expectations

Neck Pain; Dry Needling; Motivation Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636879
• Other study ID #: CEI20/009
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: May 5, 2024

Study information

• Verified date: April 2024
• Source: University of Alcala
• Contact: Daniel Pecos-Martín, PhD
• Phone: + 34 918855142
• Email: daniel.pecos[@]uah.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 5, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Neck Pain; Dry Needling; Motivation

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
Spain	Clinical University	Alcala de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin conductance (µS).	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)	Change from baseline at twenty minutes
Secondary	Heart rate variability	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.	Change from baseline at twenty minutes
Secondary	Pain intensity	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.	Change from baseline at twenty minutes
Secondary	Pressure pain threshold	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).	Change from baseline at twenty minutes.