Neck PainNCT03673319
The Patient Expectation in Dry Needling and Analgesia
A study testing Dry needling with positives expectation and Dry needling with neutral expectation in people with Neck Pain, run by University of Alcala at 2 sites in Spain.
Trial summary
This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate whether an additive effect occurs when DN is provided with an instructional set known to enhance placebo analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling with positives expectation and Dry needling with neutral expectation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Oct 2018to 31 Jul 2019
- 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
- neck pain (≥3 months of duration)
- VAS of 4-5 of pain.
- Presence of at least one active MTrP located at the upper trapezius.
Who cannot join
- Patients with previous cervical spine or shoulder surgery.
- Cervical spine radiculopathy or myelopathy.
- Systemic disease.
- Fibromyalgia.
- Pregnancy.
- Using sedative drugs.
Show all 11Show fewer
- Needle phobia.
- Bleeding disorder.
- anticoagulant medication.
- Previous experience with DN for myofascial pain.
- Skin lesion and infection or inflammatory oedema at the MTrPs site
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Institut Physiotherapy AND pain
Alcalá de Henares, Madrid, 28805
Grupo Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28871
About this study
Official title: The Influence of Patient Expectation in Dry Needling Induced Analgesia
This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate whether an additive effect occurs when DN is provided with an instructional set known to enhance placebo analgesia. External manipulation of patient expectation for receiving DN will be performed, in a similar way as has been already done in studies investigating the influence of expectation on spinal manipulative therapy interventions. The main purpose of this study will be therefore to determine, for the first time, how subjects' expectation about the effect of DN influences the resultant hypoalgesia. Analgesic effects of DN will be assessed using the conditioned pain modulation (CPM) paradigm, which has not been previously evaluated in relation to DN.
Read the detailed description
Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient.
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain".
DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.
- Conditions
- Neck Pain
- Being tested
- Dry needling with positives expectation, Dry needling with neutral expectation
- 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 needling with positives expectationProcedure or surgery
DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
Dry needling with neutral expectationProcedure or surgery
DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
| Study group | Role | What they receive |
|---|---|---|
| Positive expectative | Experimental | Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain" Receives: Procedure: Dry needling with positives expectation |
| Neutral expectatives | Experimental | Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain" Receives: Procedure: Dry needling with neutral expectation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity: Visual Analog Scale (VAS)
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN. We will follow the paradigm of Conditioned pain modulation (CPM) paradigm. CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current pain with a mark on the scale.
Measured: Change from Baseline at after intervention
Secondary outcomes (3)
Pain Pressure Threshold (PPT)
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer.
Lower values are a worse result. Higher values are a better result.
Measured: Change up 1 hour
Dry needling pain
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's pain during DN intervention.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" (the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current dry needling pain with a mark on the scale.
Measured: Change up 1 hour
Dry needling anxiety
The investigators use a Visual Analog Scale (VAS) to determine the anxiety of the patient during DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no anxiety"(the best value) and the other end representing "worst anxiety"(the worse value). Subjects were asked to rate their current dry needling anxiety with a mark on the scale
Measured: Change up 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start4 Oct 2018
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, Phd, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673319
- Sponsor's protocol ID
- CEI18/087
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IDP does not exist
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Patient Expectation in Dry Needling Induced Analgesia
- ClinicalTrials.gov ID
- NCT03673319
- Acronym / sponsor ID
- CEI18/087
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Sep 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.
This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate whether an additive effect occurs when DN is provided with an instructional set known to enhance placebo analgesia. External manipulation of patient expectation for receiving DN will be performed, in a similar way as has been already done in studies investigating the influence of expectation on spinal manipulative therapy interventions. The main purpose of this study will be therefore to determine, for the first time, how subjects' expectation about the effect of DN influences the resultant hypoalgesia. Analgesic effects of DN will be assessed using the conditioned pain modulation (CPM) paradigm, which has not been previously evaluated in relation to DN.
Detailed description
Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient.
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain".
DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive expectative | Experimental | Procedure: Dry needling with positives expectationParticipants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain" |
| Neutral expectatives | Experimental | Procedure: Dry needling with neutral expectationParticipants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- neck pain (≥3 months of duration)
- VAS of 4-5 of pain.
- Presence of at least one active MTrP located at the upper trapezius.
Key exclusion criteria (11 listed)
- Patients with previous cervical spine or shoulder surgery.
- Cervical spine radiculopathy or myelopathy.
- Systemic disease.
- Fibromyalgia.
- Pregnancy.
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 needling with positives expectationDN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain" | Procedure or surgery | Positive expectative |
| Dry needling with neutral expectationDN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain" | Procedure or surgery | Neutral expectatives |
Primary outcome
Pain Intensity: Visual Analog Scale (VAS)
Time frame: Change from Baseline at after intervention
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN. We will follow the paradigm of Conditioned pain modulation (CPM) paradigm. CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current pain with a mark on the scale.
3 secondary outcomes
Pain Pressure Threshold (PPT)
Time frame: Change up 1 hour
Dry needling pain
Time frame: Change up 1 hour
Dry needling anxiety
Time frame: Change up 1 hour
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 19 Aug 2019.
- Individual participant dataSharing planned: No. The IDP does not exist
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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.
Daniel Pecos-Martin, Phd principal investigator
Alcala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling with positives expectation and Dry needling with neutral expectation in people with Neck Pain, run by University of Alcala at 2 sites 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 11 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Intensity: Visual Analog Scale (VAS) (time frame: Change from Baseline at after intervention). 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 19 Aug 2019.