Clinical trial NCT05391568: Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
Official title: Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Ache
Cervicalgia
Cervicodynia
Neckache
Cervical Pain
Dry Needling
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Skin Conductance
timeFrame: Through study completion, an average of 20 minutes
Secondary outcomes:
measure: Pressure Pain Sensitivity
timeFrame: Baseline; Immediate (10 minutes after intervention)
measure: Pressure Pain Stimuli for Temporal Summation
timeFrame: Baseline; Immediate (10 minutes after intervention)
measure: Temporal Summation
timeFrame: Baseline; Immediate (10 minutes after intervention)
measure: Conditioned Pain Modulation (CPM)
timeFrame: Baseline; Immediate (10 minutes after intervention)
measure: Temporal Summation during conditioned stimuli.
timeFrame: Baseline; Immediate (10 minutes after intervention)
measure: Pain Intensity (Numeric Pain Rating Scale)
timeFrame: Baseline; one week after intervention
measure: Neck Pain-related Disability
timeFrame: Baseline; one week after intervention
measure: Global Rating of Change Scale (GRoC)
timeFrame: One week after intervention
measure: Kinesiophobia
timeFrame: Baseline; one week after intervention
measure: Pain Catastrophizing
timeFrame: Baseline; one week after intervention
measure: Pain Intensity during Intervention (Numeric Pain Rating Scale)
timeFrame: Baseline; immediate (ten minutes after intervention)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: