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Completed

NCT Number: NCT04060004

The Effects of Dry Needling on the Superficial Neck Musculature

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Fisioterapia, Universidad de Valladolid

Soria, 42004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Other

Dry needling is a technique used by physiotherapists.

Sham dry needling

Other

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

Electrotherapy + therapeutic exercise

Other

Standard care of neck pain.

Primary outcomes

  1. Neck pain

    Time frame: Baseline.

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

  2. 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).

  3. Cervical disability

    Time frame: Baseline.

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

  4. 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).

  5. Motor control

    Time frame: Baseline.

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

  6. 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).

Secondary outcomes

  1. Neck range of motion

    Time frame: Baseline.

    The investigators measure the neck range of motion with an inclinometer at baseline.

  2. 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).

  3. Pressure pain threshold

    Time frame: Baseline.

    The investigators measure the pressure pain threshold with a digital algometer at baseline.

  4. 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).

  5. Kinesiophobia

    Time frame: Baseline.

    The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline.

  6. 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).

  7. Pain catastrophism

    Time frame: Baseline.

    The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline.

  8. 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).

  9. Anxiety and depression

    Time frame: Baseline.

    The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline.

  10. 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).

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 16, 2019
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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