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CompletedNCT05607459Updated Jul 1, 2025

Dry Needling, Manual Therapy and Exercise for Neck Pain Management

An interventional study of Dry Needling and Therapeutic Exercise in Neck Pain, Posterior, sponsored by Camilo Jose Cela University. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Camilo Jose Cela University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neck Pain, Posterior

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Keywords

  • Dry Needling
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's enrollment of 40 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Camilo Jose Cela University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Dry Needling Group

    This group will receive dry needling, manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus) and therapeutic exercise interventions

    Other: Dry Needling · Behavioral: Therapeutic Exercise · Other: Manual Therapy

  • Active comparator
    Sham Dry Needling Group

    This group will receive manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus), therapeutic exercise interventions and a previously described sham dry needling intervention.

    Behavioral: Therapeutic Exercise · Other: Manual Therapy · Other: Sham Dry Needling

Interventions

  • OtherDry Needling

    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

  • BehavioralTherapeutic Exercise

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

  • OtherManual Therapy

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

  • OtherSham Dry Needling

    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.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    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)

    Time frame: Baseline

  2. Visual Analogue Scale

    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)

    Time frame: One month follow-up

  3. Visual Analogue Scale

    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)

    Time frame: Three months follow-up

  4. Visual Analogue Scale

    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)

    Time frame: Six months follow-up

  5. Visual Analogue Scale

    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)

    Time frame: Twelve months follow-up

Secondary outcomes

  1. Pittsburg Sleeping Quality Index

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

    Time frame: Baseline

  2. Pittsburg Sleeping Quality Index

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

    Time frame: One month follow-up

  3. Pittsburg Sleeping Quality Index

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

    Time frame: Three months follow-up

  4. Pittsburg Sleeping Quality Index

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

    Time frame: Six months follow-up

  5. Pittsburg Sleeping Quality Index

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

    Time frame: Twelve months follow-up

  6. Hospital Anxiety and Depression Scale

    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.

    Time frame: Baseline

  7. Hospital Anxiety and Depression Scale

    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.

    Time frame: One month follow-up

  8. Hospital Anxiety and Depression Scale

    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.

    Time frame: Three months follow-up

  9. Hospital Anxiety and Depression Scale

    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.

    Time frame: Six months follow-up

  10. Hospital Anxiety and Depression Scale

    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.

    Time frame: Twelve months follow-up

  11. Neck Disability Index

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

    Time frame: Baseline

  12. Neck Disability Index

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

    Time frame: One month follow-up

  13. Neck Disability Index

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

    Time frame: Three months follow-up

  14. Neck Disability Index

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

    Time frame: Six months follow-up

  15. Neck Disability Index

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

    Time frame: Twelve months follow-up

  16. Tampa Scale for Kinesiophobia

    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.

    Time frame: Baseline

  17. Tampa Scale for Kinesiophobia

    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.

    Time frame: One month follow-up

  18. Tampa Scale for Kinesiophobia

    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.

    Time frame: Three months follow-up

  19. Tampa Scale for Kinesiophobia

    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.

    Time frame: Six months follow-up

  20. Tampa Scale for Kinesiophobia

    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.

    Time frame: Twelve months follow-up

07

Study locations

1 site
  • Juan Antonio Valera-Calero
    Alcorcón, Madrid 28922, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05607459
Lead sponsor
Camilo Jose Cela University
Collaborators
Universidad Rey Juan Carlos
Responsible party
José Manuel Pérez Ortiz (Vice-dean of research, Camilo Jose Cela University) — Principal investigator
First posted
Nov 7, 2022
Start date
Nov 1, 2022
Primary completion
Mar 28, 2025
Completion
Mar 30, 2025
Last update
Jul 1, 2025

Study contacts

Juan Antonio Valera Calero, PhD
principal investigator · Camilo José Cela University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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