Neck Pain; Dry Needling; MotivationNCT04636879
Dry Needling and Patients Treatment Expectations
A study testing 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 and Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point in people with Neck Pain; Dry Needling; Motivation, run by University of Alcala at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain; Dry Needling; Motivation
- What is being tested?
- 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 and Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2021to 5 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain.
- Hiperalgesic point in Upper trapezius muscle.
Who cannot join
- Pain Irradiation toward upper limb
- Psychological disorders
- Whiplash.
- Neuropathic symptoms
- Cervical and / or Shoulder Spine Surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clinical University
Alcalá de Henares, Madrid, 2805
Patricia Martinez-Merinero, Dr, +34 918855142, patricia.m.merinero@gmail.com
About this study
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.
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.
Read the 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).
- Conditions
- Neck Pain; Dry Needling; Motivation
- Being tested
- 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
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expectation AND dry needling in the upper trapezius fibers, at the most painful pointOther
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 pointOther
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 pointOther
The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding
| Study group | Role | What they receive |
|---|---|---|
| • Group 1. Positive expectation | Experimental | "Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain." Receives: Other: Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point |
| • Group 2. Neutral Expectation | Active comparator | "Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown". Receives: Other: Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point |
| • Group 3. Negative Expectation | Active comparator | "Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit." Receives: Other: Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline at twenty minutes
Secondary outcomes (3)
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.
Measured: Change from baseline at twenty minutes
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.
Measured: Change from baseline at twenty minutes
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).
Measured: Change from baseline at twenty minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start23 Feb 2021
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain; Dry Needling; MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636879
- Sponsor's protocol ID
- CEI20/009
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04636879
- Acronym / sponsor ID
- CEI20/009
- Conditions
- Neck Pain; Dry Needling; Motivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| • Group 1. Positive expectation | Experimental | Other: Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point"Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain." |
| • Group 2. Neutral Expectation | Active comparator | Other: Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point"Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown". |
| • Group 3. Negative Expectation | Active comparator | Other: Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point"Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit." |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neck pain.
- Hiperalgesic point in Upper trapezius muscle.
Key exclusion criteria (5 listed)
- Pain Irradiation toward upper limb
- Psychological disorders
- Whiplash.
- Neuropathic symptoms
- Cervical and / or Shoulder Spine Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive expectation AND dry needling in the upper trapezius fibers, at the most painful pointThe 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 | • Group 1. Positive expectation |
| Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful pointThe subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding | Other | • Group 2. Neutral Expectation |
| Negative expectation AND dry needling in the upper trapezius fibers, at the most painful pointThe subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding | Other | • Group 3. Negative Expectation |
Primary outcome
Skin conductance (µS).
Time frame: 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)
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Pecos-Martin, PhD study chair
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point in people with Neck Pain; Dry Needling; Motivation, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Pecos-Martín, PhD (+ 34 918855142, daniel.pecos@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance (µS). (time frame: Change from baseline at twenty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.