NCT05391568

Brief Summary

Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain. Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 17, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

June 22, 2022

Status Verified

May 1, 2022

Enrollment Period

15 days

First QC Date

May 17, 2022

Last Update Submit

June 21, 2022

Conditions

Keywords

Neck AcheCervicalgiaCervicodyniaNeckacheCervical PainDry Needling

Outcome Measures

Primary Outcomes (1)

  • Skin Conductance

    Measured in the hand of the needled upper trapezius. Measured in microsiemens.

    Through study completion, an average of 20 minutes

Secondary Outcomes (11)

  • Pressure Pain Sensitivity

    Baseline; Immediate (10 minutes after intervention)

  • Pressure Pain Stimuli for Temporal Summation

    Baseline; Immediate (10 minutes after intervention)

  • Temporal Summation

    Baseline; Immediate (10 minutes after intervention)

  • Conditioned Pain Modulation (CPM)

    Baseline; Immediate (10 minutes after intervention)

  • Temporal Summation during conditioned stimuli.

    Baseline; Immediate (10 minutes after intervention)

  • +6 more secondary outcomes

Study Arms (2)

Dry Needling

EXPERIMENTAL

One single session of DN

Other: Real Dry Needling

Sham Dry Needling

SHAM COMPARATOR

One single session of Sham DN

Other: Sham Dry Needling

Interventions

Needle will be placed at trapezius muscle. "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.

Dry Needling

Sham needle will be placed at trapezius muscle. Simulated "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.

Sham Dry Needling

Eligibility Criteria

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

You may qualify if:

  • Pain in the neck area, including the upper trapezius muscle;
  • At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
  • Ability to read and understand Spanish
  • Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
  • Ability to understand, write, and speak Spanish fluently

You may not qualify if:

  • Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
  • Cervical trauma
  • Systemic diseases
  • Pregnancy
  • Psychiatric problems
  • Fear of needles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 26, 2022

Study Start

May 31, 2022

Primary Completion

June 15, 2022

Study Completion

June 20, 2022

Last Updated

June 22, 2022

Record last verified: 2022-05

Locations