Neck PainNCT02435966
Dry Needling in Patients With Chronic Neck Pain
A study testing Dry needling and Manual therapy in people with Neck Pain, run by European University of Madrid.
Trial summary
The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling and Manual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Neck pain for at least three months (or more)
- An active trigger point in either the upper trapezius or the levator scapulae
Who cannot join
- Treatment for neck pain within the previous six months
- Neck Whiplash
- Fibromyalgia
- Infection in the area under treatment
- Pharmacological treatment with anti-coagulants
- Fear to needles
- Degenerative conditions
- Pregnancy
About this study
Official title: Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.
Read the detailed description
A prospective single-blind randomized controlled trial, designed to assess the efficacy of dry needling in the treatment of chronic neck pain. The treatment regimes simulate the standard physiotherapy administered in real clinical settings. Patients in the intervention group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles). There are two control groups. In the first one, patients receive a combination of manual therapy and sham dry needling. In the second control group, patients receive no treatment in order to assess the natural history of the disease.
Patients receive two treatment sessions with an interval of 7 days and are followed up after 30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS). Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized questionnaire). Measurements are taken pre and post-test after the first and the second treatment sessions, plus once more at the follow-up, except for the Neck Disability Index (only at the beginning and after the second treatment). In the non-treated group, patients were measured at the same time intervals.
The sample size was calculated to detect a VAS difference of 2 points, the minimally clinically important difference established in the literature. Then it was doubled in order to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios, c/Valverde 26). Patients are randomized by a computer program.
Patients are explored for active trigger points in the upper trapezius and the levator scapulae. They should meet the criteria of identification established by Travell \& Simons in their Trigger point manual. The investigators also seek for trigger points following Travell \& Simons' pain maps for these two muscles, where they identify five trigger point areas. The investigators select the most active, taking pressure pain threshold measurements of all the active trigger point, normalizing the values according to normal thresholds for each of the five areas in the two muscles. The normal thresholds were assessed in a pilot study with healthy patients. The investigators administer either dry or sham dry needling to the most active (the one with the lowest pain threshold) throughout the trial.
Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a physiotherapist with 4 years of experience in the technique.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Sham Dry needling, Manual therapy
- 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 needlingDevice
Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Sham Dry needlingDevice
Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapyOther
Standard manual therapy in the upper trapezius or the levator scapulae
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy + Dry needling | Experimental | Manual therapy + Dry needling: 2 sessions, after a 7 days interval Receives: Device: Dry needling; Other: Manual therapy |
| Manual therapy + Sham Dry needling | Other | Manual therapy + Sham Dry needling: after a 7 days interval Receives: Device: Sham Dry needling; Other: Manual therapy |
| Untreated control | No intervention | Natural history of the condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
Measured: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Secondary outcomes (3)
Change in the Pressure Pain Threshold Measured by Algometer
Measured by algometer, with the standard measurement procedure
Measured: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Change in the Cervical Range of Motion Measured by Goniometer
Measured by goniometer, with the standard measurement procedure
Measured: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Change in the Neck Disability Index Questionnaire
Measured: Pre-intervention (Day 1); after 2nd intervention (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gracia Gallego Sendarrubias, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435966
- Sponsor's protocol ID
- University European of Madrid
- Status last verified
- Aug 2015
- First submitted
- 27 Mar 2015
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
PubMed 32202124
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02435966
- Acronym / sponsor ID
- University European of Madrid
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.
Detailed description
A prospective single-blind randomized controlled trial, designed to assess the efficacy of dry needling in the treatment of chronic neck pain. The treatment regimes simulate the standard physiotherapy administered in real clinical settings. Patients in the intervention group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles). There are two control groups. In the first one, patients receive a combination of manual therapy and sham dry needling. In the second control group, patients receive no treatment in order to assess the natural history of the disease.
Patients receive two treatment sessions with an interval of 7 days and are followed up after 30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS). Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized questionnaire). Measurements are taken pre and post-test after the first and the second treatment sessions, plus once more at the follow-up, except for the Neck Disability Index (only at the beginning and after the second treatment). In the non-treated group, patients were measured at the same time intervals.
The sample size was calculated to detect a VAS difference of 2 points, the minimally clinically important difference established in the literature. Then it was doubled in order to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios, c/Valverde 26). Patients are randomized by a computer program.
Patients are explored for active trigger points in the upper trapezius and the levator scapulae. They should meet the criteria of identification established by Travell \& Simons in their Trigger point manual. The investigators also seek for trigger points following Travell \& Simons' pain maps for these two muscles, where they identify five trigger point areas. The investigators select the most active, taking pressure pain threshold measurements of all the active trigger point, normalizing the values according to normal thresholds for each of the five areas in the two muscles. The normal thresholds were assessed in a pilot study with healthy patients. The investigators administer either dry or sham dry needling to the most active (the one with the lowest pain threshold) throughout the trial.
Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a physiotherapist with 4 years of experience in the technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual therapy + Dry needling | Experimental | Device: Dry needling, Other: Manual therapyManual therapy + Dry needling: 2 sessions, after a 7 days interval |
| Manual therapy + Sham Dry needling | Other | Device: Sham Dry needling, Other: Manual therapyManual therapy + Sham Dry needling: after a 7 days interval |
| Untreated control | No intervention | –Natural history of the condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Neck pain for at least three months (or more)
- An active trigger point in either the upper trapezius or the levator scapulae
Key exclusion criteria (8 listed)
- Treatment for neck pain within the previous six months
- Neck Whiplash
- Fibromyalgia
- Infection in the area under treatment
- Pharmacological treatment with anti-coagulants
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 of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132) | Device | Manual therapy + Dry needling |
| Sham Dry needlingSham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae | Device | Manual therapy + Sham Dry needling |
| Manual therapyStandard manual therapy in the upper trapezius or the levator scapulae | Other | Manual therapy + Dry needling, Manual therapy + Sham Dry needling |
Primary outcome
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
Time frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
3 secondary outcomes
Change in the Pressure Pain Threshold Measured by Algometer
Time frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Change in the Cervical Range of Motion Measured by Goniometer
Time frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Change in the Neck Disability Index Questionnaire
Time frame: Pre-intervention (Day 1); after 2nd intervention (7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32202124Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Manual therapy in people with Neck Pain, run by European University of Madrid.
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 2 inclusion and 8 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days (time frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435966, which also lists 1 linked publication.
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 7 Sep 2015.