Neck PainNCT04417491
Patient Expectations and Dry Needling
A study testing Dry Needling in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. Read more about this study
- Who is it for?
- Ages 18 to 65 months
- 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
- 5 Jun 2020to 28 Nov 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 65 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-specific mechanical neck pain of at least 3 months of duration
- 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: Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain
Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.
- Conditions
- Neck Pain
- Being tested
- Dry Needling, Sham Needling
- Keywords
- Neck Pain, Needling, Expectance
- 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
Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited
Sham NeedlingDevice
Sham dry needling with be conducted with a sham needle device. 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 |
|---|---|---|
| Dry Needling | Experimental | The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle. Receives: Device: Dry Needling |
| Sham Needling | Sham 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: Sham Needling |
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, immediately after and 1 week 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, immediately 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).
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 posted4 Jun 2020
- Study start5 Jun 2020
- Primary completion2 Nov 2020
- Study completion28 Nov 2020
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417491
- Sponsor's protocol ID
- URJC5006
- Status last verified
- Nov 2020
- First submitted
- 1 Jun 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallego-Sendarrubias GM, Voogt L, Arias-Buria JL, Bialosky J, Fernandez-de-Las-Penas C. Can Patient Expectations Modulate the Short-Term Effects of Dry Needling on Sensitivity Outcomes in Patients with Mechanical Neck Pain? A Randomized Clinical Trial. Pain Med. 2022 May 4;23(5):965-976. doi: 10.1093/pm/pnab134.
PubMed 33830234
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT04417491
- Acronym / sponsor ID
- URJC5006
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Needling, Expectance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 4 Jun 2020 (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 used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Dry NeedlingThe intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle. |
| Sham Needling | Sham comparator | Device: Sham NeedlingThe 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 65 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Non-specific mechanical neck pain of at least 3 months of duration
- 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 the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited | Device | Dry Needling |
| Sham NeedlingSham dry needling with be conducted with a sham needle device. 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 | Sham Needling |
Primary outcome
Changes in Neck Pain Intensity between baseline and follow-up periods
Time frame: Baseline, immediately 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).
2 secondary outcomes
Changes in Pressure pain sensitivity between baseline and follow-up periods
Time frame: Baseline, immediately 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 1 Dec 2020.
- Derived from this study: PubMed 33830234Gallego-Sendarrubias GM, Voogt L, Arias-Buria JL, Bialosky J, Fernandez-de-Las-Penas C. Can Patient Expectations Modulate the Short-Term Effects of Dry Needling on Sensitivity Outcomes in Patients with Mechanical Neck Pain? A Randomized Clinical Trial. Pain Med. 2022 May 4;23(5):965-976. doi: 10.1093/pm/pnab134.
- 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.
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 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 2 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 1 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, immediately after and 1 week after intervention). 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 NCT04417491, 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 1 Dec 2020.