Clinical trial NCT03345238: Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Official title: Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Dry Needling
Myofascial Pain Syndrome
Neurophysiological effects
Autonomic Nervous System
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Luis Martín Sacristán
First posted: 2017-11-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled trial with double-blind
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. Tensile band palpable.
  2. Exquisite local pain at the pressure of a taut band node.
  3. Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
  4. Painful limitation of range of mobility to complete stretching. It is considered positive when 3 of the 4 clinical criteria are found.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: Threshold of pain to pressure
timeFrame: Baseline and immediately after intervention
measure: Cervical pain and dysfunction
timeFrame: Baseline, a week after intervention and one month after the intervention
measure: Cervical pain and dysfunction
timeFrame: Baseline
measure: Cervical pain and dysfunction
timeFrame: Baseline, a week after intervention and one month after the intervention
measure: Changes related to the Autonomic Nervous System
timeFrame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
measure: Changes related to the Autonomic Nervous System
timeFrame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
measure: Changes related to the Autonomic Nervous System
timeFrame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: universidad de Alcalá de Henares
state: Madrid
Study officials:
affiliation: University of Alcala
name: Luis Martín Sacristán, MSc
role: PRINCIPAL_INVESTIGATOR
References: