NCT04636879

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2021Nov 2026

First Submitted

Initial submission to the registry

November 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

November 15, 2020

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Heart rate variability

    Change from baseline at twenty minutes

  • Pain intensity

    Change from baseline at twenty minutes

  • Pressure pain threshold

    Change from baseline at twenty minutes.

Study Arms (3)

• 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."

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".

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."

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

Interventions

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 1. Positive expectation

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 2. Neutral Expectation

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain.
  • Hiperalgesic point in Upper trapezius muscle.

You may not qualify if:

  • Pain Irradiation toward upper limb
  • Psychological disorders
  • Whiplash.
  • Neuropathic symptoms
  • Cervical and / or Shoulder Spine Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical University

Alcalá de Henares, Madrid, 2805, Spain

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Daniel Pecos-Martin, PhD

    Alcala University

    STUDY CHAIR

Central Study Contacts

Daniel Pecos-Martín, PhD

CONTACT

Daniel Somkereki, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Daniel Pecos Martín

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 19, 2020

Study Start

February 23, 2021

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

November 5, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations