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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Real Dry Needling
* Other: Sham Dry Needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy Cervical trauma Systemic diseases Pregnancy Psychiatric problems Fear of needles.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling<br>One single session of DN | Other: Real Dry Needling<br>* Needle will be placed at trapezius muscle. Fast-in, Fast-out technique will be used at the active trigger point of upper trapezius muscle.<br>|
| Sham Comparator: Sham Dry Needling<br>One single session of Sham DN | Other: Sham Dry Needling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Conductance | Measured in the hand of the needled upper trapezius. Measured in microsiemens. | Through study completion, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Sensitivity | Measurement of pressure pain threshold in C5-C6 zygapophyseal joints, dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of index finger and and the tibialis anterior muscle. | Baseline; Immediate (10 minutes after intervention) | 
| Pressure Pain Stimuli for Temporal Summation | Measurement of pressure pain stimuli until reach a 6 points in the numeric pain rating scale in the interphalangeal joint of index finger. | Baseline; Immediate (10 minutes after intervention) | 
| Temporal Summation | Pain response using a numeric pain rating scale will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger. | Baseline; Immediate (10 minutes after intervention) | 
| Conditioned Pain Modulation (CPM) | CPM will be tested using the lower extremity submaximal effort tourniquet test. Pressure pain threshold (PPT) was assessed using algometry at the dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint at the index finger. After determining the pressure pain threshold (PPT) baseline, the conditioning stimulus was induced using a modified submaximal effort tourniquet procedure.Subjects verbally rated their leg pain until 6 was reached. Although the tourniquet remained inflated, PPT algometry assessment was performed in the same location as previously described (kg/cm2) | Baseline; Immediate (10 minutes after intervention) | 
| Temporal Summation during conditioned stimuli. | Pain response using a numeric pain rating scale with a 10 scores (0-No pain - 10 The worst pain) will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger using a lower extremity submaximal effort tourniquet test | Baseline; Immediate (10 minutes after intervention) | 
| Pain Intensity (Numeric Pain Rating Scale) | Pain intensity measured with a 10 scores (0 - No pain - 10 The worst pain) numeric scale | Baseline; one week after intervention | 
| Neck Pain-related Disability | The Northwick Park Neck Pain (NPQ) assess pain related disability by measuring pain and limitations in the daily activities | Baseline; one week after intervention | 
| Global Rating of Change Scale (GRoC) | The patients answered about their perception of improvement during the treatment period on a scale ranging from -7 (a very great deal worse) to zero (about the same) to 7 (a very great deal better). | One week after intervention | 
| Kinesiophobia | The Tampa Scale for Kinesiophobia (TSK-11) was used to evaluate fear of movement and avoidance. Range from 11 to 44 points. | Baseline; one week after intervention | 
| Pain Catastrophizing | Pain catastrophizing scale (PCS) is a 12-item questionnaire with three components of catastrophizing: magnification, rumination, and helplessness (ranging from 0-52) | Baseline; one week after intervention | 
| Pain Intensity during Intervention (Numeric Pain Rating Scale) | Pain intensity of the intervention was measured on a 10 points numeric pain rating scale (NPRS), 0 (no pain) to 10 (worst pain), | Baseline; immediate (ten minutes after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck Ache, Cervicalgia, Cervicodynia, Neckache, Cervical Pain, Dry Needling