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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Real Dry Needling; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling; One single session of DN	Other: 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.
Sham Comparator: Sham Dry Needling; One single session of Sham DN	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Dry Needling; Cervicalgia; Cervical Pain; Neck Ache; Cervicodynia; Neckache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Nociceptive Pain
• Other Study ID Numbers: 2015/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No