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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391568
• Other study ID #: 2015/18
• Status: Completed
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: May 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 20, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain
• Nociceptive Pain

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Conductance	Measured in the hand of the needled upper trapezius. Measured in microsiemens.	Through study completion, an average of 20 minutes
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)