Skip to main content
OpenTrials
Completed

NCT Number: NCT05607459

Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Since neck pain is the fourth highest disabling condition (with an estimated point prevalence of 20%, lifetime prevalence up to 70% and high recurrence rates), dry needling targeting myofascial trigger points in neck muscles has been proposed as an effective treatment for reducing pain and disability in patients with chronic neck pain.

A recent meta-analysis reported whether dry needling could be recommended for this population. Low to moderate evidence suggests that dry needling can be effective at the short-term, but its effects on pressure pain sensitivity or cervical range of motion are limited.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Antonio Valera-Calero

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To be between 18 and 65 years old
  • To have been experiencing unilateral neck pain for at least 3 months
  • To have a Neck Disability Index (NDI) score >8
  • To have a Visual Analogue Scale (VAS) score >3
  • To have at least one active MTrP located in the upper trapezius or cervical multifidus muscles

Exclusion criteria

  • History of whiplash injury
  • Previous cervical surgery
  • Cervical radiculopathy or myelopathy
  • Diagnosis of fibromyalgia
  • Additional analgesic treatments during the study (e.g. physiotherapy or drugs)
  • Psychiatric disorders
  • Any contraindication to the interventions proposed (e.g. fear of needles or anticoagulants)

Treatment and study plan

dry needling

Other

Dry needling consists of a skilled intervention which uses a thin filiform needle (as those used in acupuncture) to penetrate the skin and stimulate underlying myofascial trigger points (defined as "a hyperirritable spot in skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band which is painful on manual compression and can give rise to characteristic referred pain, referred tenderness, motor dysfunction and autonomic phenomena.")

This intervention will be performed targeting the upper trapezius and cervical multifidus muscles

Therapeutic Exercise

Behavioral

Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.

Manual therapy

Other

Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.

Sham dry needling

Other

For the sham DN intervention, a similar approach will be used, but the skin will be not pierced since the material used will be a telescopic Park's sham device.

The guide tube will be pressed against the skin mark and the sham needle will be allowed to drop. The handle will be tapped briskly, but the (blunted) needle tip will not not break the skin.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Baseline

    A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)

  2. Visual Analogue Scale

    Time frame: One month follow-up

    A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)

  3. Visual Analogue Scale

    Time frame: Three months follow-up

    A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)

  4. Visual Analogue Scale

    Time frame: Six months follow-up

    A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)

  5. Visual Analogue Scale

    Time frame: Twelve months follow-up

    A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)

Secondary outcomes

  1. Pittsburg Sleeping Quality Index

    Time frame: Baseline

    This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)

  2. Pittsburg Sleeping Quality Index

    Time frame: One month follow-up

    This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)

  3. Pittsburg Sleeping Quality Index

    Time frame: Three months follow-up

    This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)

  4. Pittsburg Sleeping Quality Index

    Time frame: Six months follow-up

    This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)

  5. Pittsburg Sleeping Quality Index

    Time frame: Twelve months follow-up

    This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)

  6. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.

  7. Hospital Anxiety and Depression Scale

    Time frame: One month follow-up

    This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.

  8. Hospital Anxiety and Depression Scale

    Time frame: Three months follow-up

    This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.

  9. Hospital Anxiety and Depression Scale

    Time frame: Six months follow-up

    This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.

  10. Hospital Anxiety and Depression Scale

    Time frame: Twelve months follow-up

    This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.

  11. Neck Disability Index

    Time frame: Baseline

    This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).

  12. Neck Disability Index

    Time frame: One month follow-up

    This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).

  13. Neck Disability Index

    Time frame: Three months follow-up

    This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).

  14. Neck Disability Index

    Time frame: Six months follow-up

    This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).

  15. Neck Disability Index

    Time frame: Twelve months follow-up

    This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).

  16. Tampa Scale for Kinesiophobia

    Time frame: Baseline

    The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.

  17. Tampa Scale for Kinesiophobia

    Time frame: One month follow-up

    The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.

  18. Tampa Scale for Kinesiophobia

    Time frame: Three months follow-up

    The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.

  19. Tampa Scale for Kinesiophobia

    Time frame: Six months follow-up

    The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.

  20. Tampa Scale for Kinesiophobia

    Time frame: Twelve months follow-up

    The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2022
Registry last updated
Jul 1, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.