Neurophysiological Effects of Dry Needling in Patients With Neck Pain

NCT03345238 | Completed DMC

• 1 other identifier: 31/8/2017
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate the differences that may be experienced in pain and cervical disability, before, during and just after the intervention of the Deep Dry Needling in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP in Patients with neck pain, assessing, in turn, the neurophysiological effects on the Autonomic Nervous System. Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease of pain and cervical disability index and increase of pressure pain threshold; Than the Deep Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in patients with chronic neck pain. Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in patients with chronic neck pain attributable to Myofascial Pain Syndrome.

Conditions

Myofascial Pain Syndrome

Keywords

Dry Needling; Myofascial Pain Syndrome; Neurophysiological effects; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Efficacy of Deep Dry Needling applied on Active Myofascial Trigger Points (MTP) vs. latent MTP versus outside MTP, on pain reduction in patients with chronic neck pain.

  Checkin the Intensity of pain with the Visual Analogic Scale. It is a 100 mm line that measures the intensity of pain.The left end of the line represents the absence of pain, while the far right represents the worst pain imaginable. The numerical scale of intensity of pain adds a numerical ranking where 1 is no pain and 10 the worst pain imaginable.

  Baseline, during intervention, immediately after intervention, 1, 6, 12, 24, 48 and 72 hours after intervention, a week after intervention and one month after the intervention

Secondary Outcomes (7)

• Threshold of pain to pressure

  Baseline and immediately after intervention

• Cervical pain and dysfunction

  Baseline, a week after intervention and one month after the intervention

• Cervical pain and dysfunction

  Baseline

• Cervical pain and dysfunction

  Baseline, a week after intervention and one month after the intervention

• Changes related to the Autonomic Nervous System

  Baseline, during intervention and after intervention (1 and 10 minutes after intervention)

Study Arms (3)

Active MTP

EXPERIMENTAL

Procedure: Deep Dry Needling

Latent MTP

EXPERIMENTAL

Procedure: Deep Dry Needling

Out of MTP

EXPERIMENTAL

Procedure: Deep Dry Needling

Interventions

Deep Dry Needling PROCEDURE

Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.

Active MTP; Latent MTP; Out of MTP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-specific neck pain, unilateral or bilateral.
• Neck pain ≥ 3 months of duration.
• Presence of active and latent MTP in the upper, left, right or bilateral trapezius muscle, in relation to the patient's neck pain.
• Clinical criteria recommended to identify active and latent MTP:
• Tensile band palpable.
• Exquisite local pain at the pressure of a taut band node.
• Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
• Painful limitation of range of mobility to complete stretching. It is considered positive when 3 of the 4 clinical criteria are found.

You may not qualify if:

• Unsurpassed fear of needles.
• Coagulation disorders.
• Specific alterations of the cervical region in the clinical history.
• Infiltration of corticosteroids or local anesthetics during a year before the study.
• Surgical intervention of the cervical region or previous shoulder.
• Skin lesions in the area, as well as infection or inflammation.
• Taking analgesic, anti-inflammatory or anticoagulant medication the week before the study.
• Treatment of MTP or Deep Dry Needling in the neck region in the 6 months prior to the intervention.
• Cognitive deficit in the medical history.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Luis Martín Sacristán: collaborator

Study Sites (1)

universidad de Alcalá de Henares

Alcalá de Henares, Madrid, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Luis Martín Sacristán, MSc

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tesis Director

Model Details: Randomized controlled trial with double-blind

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: November 17, 2017
• Study Start: March 13, 2017
• Primary Completion: December 29, 2017
• Study Completion: August 10, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)