Neck PainNCT03592095
Blinding and Previous Experiences of Dry Needling
A study testing Dry needling in people with Neck Pain, run by European University of Madrid at 1 site in Spain.
Trial summary
Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jun 2020to 10 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific mechanical neck pain of at least 3 months of duration
- Between 18-60 years old
- At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms
Who cannot join
- whiplash injury;
- previous cervical or thoracic surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone physical therapy in the previous 6 months;
- fear to needles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial
Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. These positive results are thought to be the consequence of specific neurophysiological and mechanical processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is still a topic of debate. This trial addresses one of the major methodological issues in needle testing,the effects of proper blinding. DN is a specific technique that is not easily be replaced by another comparable intervention. A sham needle with a blunt tip was created that simulates penetration into the skin without actually doing so. Research about a valid method for the control in needling studies is for this reason of particular relevance. A proper blinding technique is of importance to further the field of DN.
Read the detailed description
The objectives of this study are to analysize short-term effects on pain intensity and pressure pain sensitivity according to previous experience (blinding) in subjects with mechanical neck pain receiving real or sham-DN and to determine the success in masking DN versus sham DN in patients with mechanical neck pain based on prior experience with this technique.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Placebo needle
- Keywords
- Dry needling, Placebo, Myofascial pain syndrome, Blinding
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
Real dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited
Placebo needleDevice
Sham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient.
| Study group | Role | What they receive |
|---|---|---|
| DN group | Experimental | The intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle. Receives: Device: Dry needling |
| Placebo needle | Placebo comparator | The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. Receives: Device: Placebo needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neck Pain Intensity between baseline and follow-up periods
The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).
Measured: Baseline, inmediately after and 1 week after intervention
Identification (blinding) of the needling intervention
Participants will be asked directly after the intervention whether they thought they had received a real intervention or a sham. Answering categories were: 'yes' (real DN) or 'no' (sham DN).
Measured: Inmediately after intervention
Secondary outcomes (2)
Changes in Pressure pain sensitivity between baseline and follow-up periods
Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel)
Measured: Baseline, inmediately after and 1 week after intervention
Changes in patients self-perceived improvement between baseline and follow-up periods
Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).
Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively
Measured: Baseline and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start4 Jun 2020
- Primary completion2 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT03592095
- Sponsor's protocol ID
- Hulp:5006
- Status last verified
- Dec 2020
- First submitted
- 2 Jun 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03592095
- Acronym / sponsor ID
- Hulp:5006
- Conditions
- Neck Pain
- Keywords
- Dry needling, Placebo, Myofascial pain syndrome, Blinding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 19 Jul 2018 (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.
Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. These positive results are thought to be the consequence of specific neurophysiological and mechanical processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is still a topic of debate. This trial addresses one of the major methodological issues in needle testing,the effects of proper blinding. DN is a specific technique that is not easily be replaced by another comparable intervention. A sham needle with a blunt tip was created that simulates penetration into the skin without actually doing so. Research about a valid method for the control in needling studies is for this reason of particular relevance. A proper blinding technique is of importance to further the field of DN.
Detailed description
The objectives of this study are to analysize short-term effects on pain intensity and pressure pain sensitivity according to previous experience (blinding) in subjects with mechanical neck pain receiving real or sham-DN and to determine the success in masking DN versus sham DN in patients with mechanical neck pain based on prior experience with this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN group | Experimental | Device: Dry needlingThe intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle. |
| Placebo needle | Placebo comparator | Device: Placebo needleThe placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-specific mechanical neck pain of at least 3 months of duration
- Between 18-60 years old
- At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms
Key exclusion criteria (6 listed)
- whiplash injury;
- previous cervical or thoracic surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone physical therapy in the previous 6 months;
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 needlingReal dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited | Device | DN group |
| Placebo needleSham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient. | Device | Placebo needle |
Primary outcome
Changes in Neck Pain Intensity between baseline and follow-up periods
Time frame: Baseline, inmediately after and 1 week after intervention
The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).
Identification (blinding) of the needling intervention
Time frame: Inmediately after intervention
Participants will be asked directly after the intervention whether they thought they had received a real intervention or a sham. Answering categories were: 'yes' (real DN) or 'no' (sham DN).
2 secondary outcomes
Changes in Pressure pain sensitivity between baseline and follow-up periods
Time frame: Baseline, inmediately after and 1 week after intervention
Changes in patients self-perceived improvement between baseline and follow-up periods
Time frame: Baseline and 1 week after intervention
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 14 Dec 2020.
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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.
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 in people with Neck Pain, run by European University of Madrid 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 3 inclusion and 6 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 14 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
Changes in Neck Pain Intensity between baseline and follow-up periods (time frame: Baseline, inmediately after and 1 week after intervention). The study lists 2 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 14 Dec 2020.