Neck Pain, PosteriorNCT05607459
Dry Needling, Manual Therapy and Exercise for Neck Pain Management
A study testing Dry Needling, Therapeutic Exercise and Manual Therapy in people with Neck Pain, Posterior, run by Camilo Jose Cela University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Posterior
- What is being tested?
- Dry Needling, Therapeutic Exercise and Manual Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial
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.
- Conditions
- Neck Pain, Posterior
- Being tested
- Dry Needling, Therapeutic Exercise, Manual Therapy, Sham Dry Needling
- Keywords
- Dry Needling
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
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 ExerciseBehavioural
Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.
Manual TherapyOther
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 NeedlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | 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 Receives: Other: Dry Needling; Behavioral: Therapeutic Exercise; Other: Manual Therapy |
| Sham Dry Needling Group | Active comparator | 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. Receives: Behavioral: Therapeutic Exercise; Other: Manual Therapy; Other: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
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)
Measured: One month follow-up
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)
Measured: Three months follow-up
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)
Measured: Six months follow-up
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)
Measured: Twelve months follow-up
Secondary outcomes (20)
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)
Measured: Baseline
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)
Measured: One month follow-up
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)
Measured: Three months follow-up
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)
Measured: Six months follow-up
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)
Measured: Twelve months follow-up
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.
Measured: Baseline
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.
Measured: One month follow-up
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.
Measured: Three months follow-up
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.
Measured: Six months follow-up
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.
Measured: Twelve months follow-up
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).
Measured: Baseline
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).
Measured: One month follow-up
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).
Measured: Three months follow-up
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).
Measured: Six months follow-up
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).
Measured: Twelve months follow-up
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.
Measured: Baseline
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.
Measured: One month follow-up
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.
Measured: Three months follow-up
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.
Measured: Six months follow-up
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.
Measured: Twelve months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Nov 2022
- Primary completion28 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain, PosteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, controlled and single-blinded clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, José Manuel Pérez Ortiz, Camilo Jose Cela University
- Investigators
- Juan Antonio Valera Calero, PhD, Principal investigator, Camilo José Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607459
- Sponsor's protocol ID
- PhD-MML
- Status last verified
- Jun 2025
- First submitted
- 28 Oct 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05607459
- Acronym / sponsor ID
- PhD-MML
- Conditions
- Neck Pain, Posterior
- Keywords
- Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel, controlled and single-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Other: Dry Needling, Behavioral: Therapeutic Exercise, Other: Manual TherapyThis 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 |
| Sham Dry Needling Group | Active comparator | Behavioral: Therapeutic Exercise, Other: Manual Therapy, Other: Sham Dry NeedlingThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingDry 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 | Other | Dry Needling Group |
| Therapeutic ExercisePatients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles. | Behavioural | Dry Needling Group, Sham Dry Needling Group |
| Manual TherapyPatients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle. | Other | Dry Needling Group, Sham Dry Needling Group |
| Sham Dry NeedlingFor 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. | Other | Sham Dry Needling Group |
Primary outcome
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)
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)
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)
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)
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)
20 secondary outcomes
Pittsburg Sleeping Quality Index
Time frame: Baseline
Pittsburg Sleeping Quality Index
Time frame: One month follow-up
Pittsburg Sleeping Quality Index
Time frame: Three months follow-up
Pittsburg Sleeping Quality Index
Time frame: Six months follow-up
Pittsburg Sleeping Quality Index
Time frame: Twelve months follow-up
Hospital Anxiety and Depression Scale
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: One month follow-up
Hospital Anxiety and Depression Scale
Time frame: Three months follow-up
Hospital Anxiety and Depression Scale
Time frame: Six months follow-up
Hospital Anxiety and Depression Scale
Time frame: Twelve months follow-up
Neck Disability Index
Time frame: Baseline
Neck Disability Index
Time frame: One month follow-up
Neck Disability Index
Time frame: Three months follow-up
Neck Disability Index
Time frame: Six months follow-up
Neck Disability Index
Time frame: Twelve months follow-up
Tampa Scale for Kinesiophobia
Time frame: Baseline
Tampa Scale for Kinesiophobia
Time frame: One month follow-up
Tampa Scale for Kinesiophobia
Time frame: Three months follow-up
Tampa Scale for Kinesiophobia
Time frame: Six months follow-up
Tampa Scale for Kinesiophobia
Time frame: Twelve months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Antonio Valera Calero, PhD principal investigator
Camilo José Cela University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, Therapeutic Exercise and Manual Therapy in people with Neck Pain, Posterior, run by Camilo Jose Cela University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.