Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain

NCT ID: NCT05391568

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-06-20

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.

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.

Study Aims:

Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN

Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.

Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)

Aim #4: The secondary aim of the study is to correlate effects between clinical and other variables.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dry Needling

One single session of DN

Group Type: EXPERIMENTAL

Real Dry Needling

Intervention Type: OTHER

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

Sham Dry Needling

One single session of Sham DN

Group Type: SHAM_COMPARATOR

Sham Dry Needling

Intervention Type: OTHER

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.

Interventions

Real Dry Needling

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

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Pain in the neck area, including the upper trapezius muscle;

2. At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)

3. Ability to read and understand Spanish

4. Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater

5. Ability to understand, write, and speak Spanish fluently

Exclusion Criteria

1. Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy

2. Cervical trauma

3. Systemic diseases

4. Pregnancy

5. Psychiatric problems

6. Fear of needles.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

2015/18

Identifier Type: -

Identifier Source: org_study_id