The Effects of Dry Needling on the Superficial Neck Musculature

NCT04060004 | Completed

• 1 other identifier: 1.0 14/12/2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain

Keywords

physical therapy

Outcome Measures

Primary Outcomes (6)

• Neck pain

  The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.

  Baseline.

• Neck pain

  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

  The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.

  Baseline.

• Cervical disability

  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

  The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.

  Baseline.

• Motor control

  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 Outcomes (10)

• Neck range of motion

  Baseline.

• Neck range of motion

  Through study completion, an average 11 days.

• Pressure pain threshold

  Baseline.

• Pressure pain threshold

  Through study completion, an average 11 days.

• Kinesiophobia

  Baseline.

Study Arms (3)

Control group

OTHER

Electrotherapy + therapeutic exercise

Other: Electrotherapy + therapeutic exercise

Experimental group 1

EXPERIMENTAL

Electrotherapy + therapeutic exercise + dry needling

Other: Dry needling; Other: Electrotherapy + therapeutic exercise

Experimental group 2

PLACEBO COMPARATOR

Electrotherapy + therapeutic exercise + sham dry needling

Other: Sham dry needling; Other: Electrotherapy + therapeutic exercise

Interventions

Dry needling OTHER

Dry needling is a technique used by physiotherapists.

Experimental group 1

Sham dry needling OTHER

Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.

Experimental group 2

Electrotherapy + therapeutic exercise OTHER

Standard care of neck pain.

Control group; Experimental group 1; Experimental group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

Facultad de Fisioterapia, Universidad de Valladolid

Soria, 42004, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling; Electric Stimulation Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

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

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 16, 2019
• Study Start: September 5, 2019
• Primary Completion: February 20, 2020
• Study Completion: May 27, 2021
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

ES (1)