Dry Needling and Patients Treatment Expectations
Primary Purpose
Neck Pain; Dry Needling; Motivation
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain; Dry Needling; Motivation
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
Sites / Locations
- Clinical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
• Group 1. Positive expectation
• Group 2. Neutral Expectation
• Group 3. Negative Expectation
Arm Description
"Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain."
"Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown".
"Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit."
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT04636879
First Posted
November 15, 2020
Last Updated
August 24, 2023
Sponsor
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT04636879
Brief Title
Dry Needling and Patients Treatment Expectations
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain; Dry Needling; Motivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
• Group 1. Positive expectation
Arm Type
Experimental
Arm Description
"Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain."
Arm Title
• Group 2. Neutral Expectation
Arm Type
Active Comparator
Arm Description
"Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown".
Arm Title
• Group 3. Negative Expectation
Arm Type
Active Comparator
Arm Description
"Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit."
Intervention Type
Other
Intervention Name(s)
Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point
Intervention Description
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
Intervention Name(s)
Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point
Intervention Description
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
Intervention Name(s)
Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point
Intervention Description
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 Measure Information:
Title
Skin conductance (µS).
Description
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)
Time Frame
Change from baseline at twenty minutes
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
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.
Time Frame
Change from baseline at twenty minutes
Title
Pain intensity
Description
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.
Time Frame
Change from baseline at twenty minutes
Title
Pressure pain threshold
Description
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).
Time Frame
Change from baseline at twenty minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Pecos-Martín, PhD
Phone
+ 34 918855142
Email
daniel.pecos@uah.es
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Somkereki, Master
Phone
636869373
Email
clinica.fisio@fgua.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Organizational Affiliation
Alcala University
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical University
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
2805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, Dr
Phone
+34 918855142
Email
patricia.m.merinero@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Dry Needling and Patients Treatment Expectations
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