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NCT Number: NCT05391568

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

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real dry needling

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

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.

Primary outcomes

  1. Skin Conductance

    Time frame: Through study completion, an average of 20 minutes

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

Secondary outcomes

  1. Pressure Pain Sensitivity

    Time frame: Baseline; Immediate (10 minutes after intervention)

    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.

  2. Pressure Pain Stimuli for Temporal Summation

    Time frame: Baseline; Immediate (10 minutes after intervention)

    Measurement of pressure pain stimuli until reach a 6 points in the numeric pain rating scale in the interphalangeal joint of index finger.

  3. Temporal Summation

    Time frame: Baseline; Immediate (10 minutes after intervention)

    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.

  4. Conditioned Pain Modulation (CPM)

    Time frame: Baseline; Immediate (10 minutes after intervention)

    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)

  5. Temporal Summation during conditioned stimuli.

    Time frame: Baseline; Immediate (10 minutes after intervention)

    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

  6. Pain Intensity (Numeric Pain Rating Scale)

    Time frame: Baseline; one week after intervention

    Pain intensity measured with a 10 scores (0 - No pain - 10 The worst pain) numeric scale

  7. Neck Pain-related Disability

    Time frame: Baseline; one week after intervention

    The Northwick Park Neck Pain (NPQ) assess pain related disability by measuring pain and limitations in the daily activities

  8. Global Rating of Change Scale (GRoC)

    Time frame: One week after intervention

    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).

  9. Kinesiophobia

    Time frame: Baseline; one week after intervention

    The Tampa Scale for Kinesiophobia (TSK-11) was used to evaluate fear of movement and avoidance. Range from 11 to 44 points.

  10. Pain Catastrophizing

    Time frame: Baseline; one week after intervention

    Pain catastrophizing scale (PCS) is a 12-item questionnaire with three components of catastrophizing: magnification, rumination, and helplessness (ranging from 0-52)

  11. Pain Intensity during Intervention (Numeric Pain Rating Scale)

    Time frame: Baseline; immediate (ten minutes after intervention)

    Pain intensity of the intervention was measured on a 10 points numeric pain rating scale (NPRS), 0 (no pain) to 10 (worst pain),

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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