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

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT05391568
Collaborator
(none)
60
1
2
20
91.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Real Dry Needling
  • Other: Sham Dry Needling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.
Actual Study Start Date :
May 31, 2022
Actual Primary Completion Date :
Jun 15, 2022
Actual Study Completion Date :
Jun 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skin Conductance [Through study completion, an average of 20 minutes]

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

Secondary Outcome Measures

  1. Pressure Pain Sensitivity [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 [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 [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) [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. [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) [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 [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) [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 [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 [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) [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),

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Complutense de Madrid Madrid Spain 28040

Sponsors and Collaborators

  • Universidad Complutense de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT05391568
Other Study ID Numbers:
  • 2015/18
First Posted:
May 26, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidad Complutense de Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022