The Effects of Dry Needling on the Superficial Neck Musculature

July 18, 2023 updated by: Ricardo Medrano de la Fuente, University of Valladolid

The Effects of Dry Needling on the Superficial Neck Musculature in Patients With Chronic Myofascial Pain: A Randomized Controlled Trial

The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena.

To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points.

This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group.

In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups.

For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group.

The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Soria, Spain, 42004
        • Facultad de Fisioterapia, Universidad de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with myofascial neck pain
  • Presence of at least one active myofascial trigger point on the superficial neck musculature
  • Neck pain of at least 3 months
  • Age 18-70
  • Pain intensity between 20 and 100 mm in the Analog Visual Scale
  • Neck disability index (NDI) greater than or equal to 15 points
  • Spanish speakers
  • Patients who do not present contraindications for the use of dry needling (anticoagulants, nickel allergy or belenophobia)
  • Patients who have not received physiotherapy or pharmacological treatment for neck pain for the last three months

Exclusion Criteria:

  • History of cervical trauma
  • Cervical spine surgery
  • Vertebral fracture
  • Cervical pain associated with whiplash
  • Red flags (tumor, metabolic disorders or rheumatoid arthritis)
  • Inflammatory lesion in the neck region
  • Pregnancy
  • Fibromyalgia diagnosis
  • Neck pain associated with radiculopathy
  • Patients pending legal litigation
  • Psychiatric pathology diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Electrotherapy + therapeutic exercise
Other: Electrotherapy + therapeutic exercise
Standard care of neck pain.
Experimental: Experimental group 1
Electrotherapy + therapeutic exercise + dry needling
Other: Electrotherapy + therapeutic exercise
Standard care of neck pain.
Other: Dry needling
Dry needling is a technique used by physiotherapists.
Placebo Comparator: Experimental group 2
Electrotherapy + therapeutic exercise + sham dry needling
Other: Electrotherapy + therapeutic exercise
Standard care of neck pain.
Other: Sham dry needling
Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck pain
Time Frame: Baseline.
The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.
Baseline.
Neck pain
Time Frame: Through study completion, an average of 11 days.
The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average of 11 days.
Cervical disability
Time Frame: Baseline.
The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.
Baseline.
Cervical disability
Time Frame: Through study completion, an average 11 days.
The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.
Motor control
Time Frame: Baseline.
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.
Baseline.
Motor control
Time Frame: Through study completion, an average 11 days.
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck range of motion
Time Frame: Baseline.
The investigators measure the neck range of motion with an inclinometer at baseline.
Baseline.
Neck range of motion
Time Frame: Through study completion, an average 11 days.
The investigators measure the neck range of motion with an inclinometer at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.
Pressure pain threshold
Time Frame: Baseline.
The investigators measure the pressure pain threshold with a digital algometer at baseline.
Baseline.
Pressure pain threshold
Time Frame: Through study completion, an average 11 days.
The investigators measure the pressure pain threshold with a digital algometer at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.
Kinesiophobia
Time Frame: Baseline.
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline.
Baseline.
Kinesiophobia
Time Frame: Through study completion, an average 11 days.
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at the end of the intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.
Pain catastrophism
Time Frame: Baseline.
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline.
Baseline.
Pain catastrophism
Time Frame: Through study completion, an average 11 days.
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at the end of intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.
Anxiety and depression
Time Frame: Baseline.
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline.
Baseline.
Anxiety and depression
Time Frame: Through study completion, an average 11 days.
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at the end of intervention (through study completion, an average 11 days).
Through study completion, an average 11 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

May 27, 2021

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0 14/12/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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