Pain, NeckNCT03095365
Dry Needling and Pain Education in the Treatment of Chronic Neck Pain
A study testing Dry needling, Pain neuroscience education and Conventional treatment in people with Pain, Neck, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Neck
- What is being tested?
- Dry needling, Pain neuroscience education and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2017to 5 Sep 2017
- 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
- Mechanical neck pain for at least 12 weeks
- 10% or higher on the Neck Disability Index questionnaire
- 20mm or higher on the Visual Analogue Scale (VAS) of neck pain
- Presence of at least one active myofascial trigger point
Who cannot join
- Neck pain associated with whiplash injuries
- Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
- Neck pain with cervical radiculopathy
- Neck pain associated with externalized cervical disc herniation
- Fibromyalgia syndrome
- Previous neck surgery
- Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
About this study
Official title: Dry Needling and Pain Neuroscience Education in Chronic Pain Patients
to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.
- Conditions
- Pain, Neck
- Being tested
- Dry needling, Pain neuroscience education, Conventional treatment
- 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
Insertion of solid filament needles in the muscle
Pain neuroscience educationOther
Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain
Conventional treatmentOther
Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Active comparator | Received Dry needling in the neck muscles. Receives: Other: Dry needling |
| Conventional treatment | Active comparator | the participants received the conventional treatment for non-specific neck pain. Receives: Other: Conventional treatment |
| Dry needling and pain neuroscience education | Experimental | Received the same treatment as dry needling group and pain education. Receives: Other: Dry needling; Other: Pain neuroscience education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using Visual Analogue Scale
Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side
Measured: 3 months
Secondary outcomes (6)
Medication intake
Medication use: number of pills
Measured: 3 months
Disability using Neck Disability Index
Neck disability index: patients ability to function in daily life activities.
Measured: 3 months
Kinesiophobia using Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia: participants pain-related fear of movement and (re)injury
Measured: 3 months
Catastrophizing using Pain Catastrophizing Scale
Pain Catastrophizing Scale: propensity to catastrophize about pain
Measured: 3 months
Pain anxiety using Pain Anxiety Symptoms Scale
Pain Anxiety Symptoms Scale: The anxiety behaviors associated with pain
Measured: 3 months
Beck Depression Inventory-II
Self-report measure to assess the severity of depressive symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start14 Mar 2017
- Primary completion1 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josue Fernandez-Carnero, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095365
- Sponsor's protocol ID
- 03/2017
- Status last verified
- Sep 2017
- First submitted
- 14 Mar 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valiente-Castrillo P, Martin-Pintado-Zugasti A, Calvo-Lobo C, Beltran-Alacreu H, Fernandez-Carnero J. Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial. Acupunct Med. 2021 Apr;39(2):91-105. doi: 10.1177/0964528420920300. Epub 2020 May 5.
PubMed 32370545
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling and Pain Neuroscience Education in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03095365
- Acronym / sponsor ID
- 03/2017
- Conditions
- Pain, Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 29 Mar 2017 (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.
to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Active comparator | Other: Dry needlingReceived Dry needling in the neck muscles. |
| Conventional treatment | Active comparator | Other: Conventional treatmentthe participants received the conventional treatment for non-specific neck pain. |
| Dry needling and pain neuroscience education | Experimental | Other: Dry needling, Other: Pain neuroscience educationReceived the same treatment as dry needling group and pain education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanical neck pain for at least 12 weeks
- 10% or higher on the Neck Disability Index questionnaire
- 20mm or higher on the Visual Analogue Scale (VAS) of neck pain
- Presence of at least one active myofascial trigger point
Key exclusion criteria (7 listed)
- Neck pain associated with whiplash injuries
- Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
- Neck pain with cervical radiculopathy
- Neck pain associated with externalized cervical disc herniation
- Fibromyalgia syndrome
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 needlingInsertion of solid filament needles in the muscle | Other | Dry needling, Dry needling and pain neuroscience education |
| Pain neuroscience educationExplanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain | Other | Dry needling and pain neuroscience education |
| Conventional treatmentElectrotherapy: Transcutaneous electrical nerve stimulation and microwaves | Other | Conventional treatment |
Primary outcome
Pain using Visual Analogue Scale
Time frame: 3 months
Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side
6 secondary outcomes
Medication intake
Time frame: 3 months
Disability using Neck Disability Index
Time frame: 3 months
Kinesiophobia using Tampa Scale of Kinesiophobia
Time frame: 3 months
Catastrophizing using Pain Catastrophizing Scale
Time frame: 3 months
Pain anxiety using Pain Anxiety Symptoms Scale
Time frame: 3 months
Beck Depression Inventory-II
Time frame: 3 months
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 8 Sep 2017.
- Derived from this study: PubMed 32370545Valiente-Castrillo P, Martin-Pintado-Zugasti A, Calvo-Lobo C, Beltran-Alacreu H, Fernandez-Carnero J. Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial. Acupunct Med. 2021 Apr;39(2):91-105. doi: 10.1177/0964528420920300. Epub 2020 May 5.
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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.
Josue Fernandez-Carnero, PhD study director
Universidad Rey Juan Carlos
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, Pain neuroscience education and Conventional treatment in people with Pain, Neck, run by Universidad Rey Juan Carlos 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 4 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 8 Sep 2017. 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?
Pain using Visual Analogue Scale (time frame: 3 months). 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 NCT03095365, 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 8 Sep 2017.