Neck PainNCT06453408
Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain
A study testing Punción seca con aguja retráctil and Punción seca con aguja normativa. in people with Neck Pain, run by University of Alcala.
Trial summary
This study aims to validate a placebo dry needling protocol for patients with non-specific neck pain and investigate whether prior experience with dry needling affects their ability to distinguish between real and placebo treatments, and how this impacts outcomes. 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?
- Punción seca con aguja retráctil and Punción seca con aguja normativa.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2024to Oct 2024
- 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
- Non-specific neck pain, unilateral or bilateral.
- Neck pain lasting ≥ 3 months.
- Presence of active myofascial trigger point (MTrP) in the upper trapezius muscle, left, right or bilateral, in relation to the patient's neck pain.
Who cannot join
- Fear or phobia of needles
- Skin lesions, infection or inflammation in the area to be pricked
- Specific alterations of the cervical region in the medical history
- Coagulation disorders
- Surgical intervention of the cervical or anterior shoulder region
- Undergoing pharmacological treatment with analgesics, anti-inflammatory drugs or anticoagulants in the week prior to the study.
Show all 9Show fewer
- Having received physiotherapy treatment in the neck region in the 6 months prior to the intervention.
- Infiltration of corticosteroids or local anaesthetics up to one year prior to the study.
- Cognitive deficits in the medical history.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain: a Randomised Controlled Clinical Trial
This study aims to validate a placebo dry needling protocol for patients with non-specific neck pain and investigate whether prior experience with dry needling affects their ability to distinguish between real and placebo treatments, and how this impacts outcomes. Seventy participants aged 18-65 will be recruited and divided into two groups based on their previous dry needling experience, then randomized into real or placebo needling groups.
Assessment will be carried out before treatment, immediately after the procedure and one week later. Pain intensity, pain threshold to pressure, cervical range of motion, level of disability and presence of central sensitisation will also be measured.
Read the detailed description
Background: There is currently no valid and reliable method available to perform a placebo dry needling protocol in patients with non-specific neck pain. The lack of uniformity and validity in placebo dry needling methods hinders research on the specific effects of this technique. In addition, there is no solid evidence on how patients' previous experiences affect their expectations of treatment. An effective placebo dry needling protocol is essential for future research on the effectiveness of dry needling in randomised controlled clinical trials.
Objective: The main objective of this study is to validate a placebo dry needling protocol. The secondary objective is to examine whether the patient's previous experience with dry needling influences their ability to discern between having received a real or placebo needling and how this impacts on the outcomes of the intervention.
Material and method: 70 participants aged 18-65 years with non-specific neck pain who meet the inclusion criteria will be recruited. They will be assigned to one of two groups, those who have previously received dry needling and those who have not. Thereafter, members of each group will be randomised and assigned to either the real dry needling or placebo group. Assessment will be carried out before treatment, immediately after the procedure and one week later. Pain intensity, pain threshold to pressure, cervical range of motion, level of disability and presence of central sensitisation will also be measured.
- Conditions
- Neck Pain
- Being tested
- Punción seca con aguja retráctil, Punción seca con aguja normativa.
- Keywords
- dry needling, validation, placebo, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punción seca con aguja retráctilProcedure or surgery
Also called DONGBANG AcuPrime® de 0,30 x 30mm.
The placebo dry needling protocol will be performed in the same position, with identical antiseptic measures and the same number of simulated incisions as the real dry needling protocol, using DONGBANG AcuPrime® 0.30 x 30mm blunt-tipped placebo needles with a retractable handle. These needles simulate the sensation of needle contact without penetrating the skin. The therapist will hold the needle and guide tube, pressing the tube against the skin and simulating needle manipulation. Changes in pressure direction will mimic the real technique. The protocol will end with compression using an alcohol swab and an upper trapezius stretch.
Participants in both groups will receive the same information about the sensations of the dry needling procedure. At the beginning, they will be informed that they may or may not feel the needle insertion. They will also be told that the physiotherapist will manually manipulate the needle multiple times during the procedure.
Punción seca con aguja normativa.Procedure or surgery
Also called APS Regular Agupunt 0,30 × 30 mm
To perform the actual SP, patients shall be asked to lie prone with arms close to the body. The dry needling shall be performed with a 0,30 × 30 mm DN needle (APS Regular Agupunt) with a guide tube. The therapist shall first clean the area with alcohol. The trapezius muscle is then firmly grasped with a clamp between the thumb and index finger, so that the needle is directed deep into the index finger until the tip of the needle is felt to be approaching (33). This procedure involves an approximate insertion of the needle to a depth of 30 mm and ensures the intramuscular penetration necessary for dry needling. Puncture of the PGM shall be performed using the Hong technique (34), performing up to 12 inlets and outlets, at a frequency of 1 Hz. When the needle is withdrawn, the area is firmly compressed with cotton wool for 60 seconds. Finally, the upper trapezius muscle is stretched, following the technique originally described by Simons (35).
| Study group | Role | What they receive |
|---|---|---|
| Placebo, sin experiencia | Sham comparator | Group of patients with no previous experience in dry needling, will be given placebo dry needling Receives: Procedure: Punción seca con aguja retráctil |
| Placebo, con experiencia | Sham comparator | Group of patients with previous experience in dry needling, will be given placebo dry needling Receives: Procedure: Punción seca con aguja retráctil |
| Real, sin experiencia | Experimental | Group of patients with no previous experience in dry needling, real dry needling will be applied Receives: Procedure: Punción seca con aguja normativa. |
| Real, con experiencia | Experimental | Group of patients with previous experience in dry needling, real dry needling will be applied. Receives: Procedure: Punción seca con aguja normativa. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful identification rate of group assignment
A Questionnaire of its own, designed to record participants' perceptions of the perceived intervention, will be used. Participants will be asked to select which group they believe they belong to by choosing one of five possible responses:
- I strongly believe I was assigned to the treatment group.
- I believe to some extent that I was assigned to the treatment group.
- I believe to some extent that I was assigned to the control group.
- I strongly believe that I was assigned to the control group.
- I am not sure
Measured: Immediately after the intervention and one week later, in order to see if any participants change their response.
Secondary outcomes (5)
Pain intensity
Visual Analogic Scale
Measured: Before and immediately after the intervention, and a new assessment will be carried out one week later.
Neck disability
neck disability index
Measured: Before and one week after the intervention.
Cervical Range of Motion
Grades
Measured: Before intervention, immediately after intervention and after one week.
central sensitisation
The Central Sensitisation Inventory (CSI)
Measured: Before the intervention and one week after
Pressure pain threshold
kg/sec
Measured: Before the intervention, immediately after the intervention and one week afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leire Vázquez Casar, University of Alcala
- Investigators
- Leire Vazquez-Casar, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453408
- Sponsor's protocol ID
- PS-Leire
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pariente J, White P, Frackowiak RS, Lewith G. Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage. 2005 May 1;25(4):1161-7. doi: 10.1016/j.neuroimage.2005.01.016.
PubMed 15850733Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.
PubMed 29228289Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932Andrade Ortega JA, Delgado Martinez AD, Almecija Ruiz R. [Validation of a Spanish version of the Neck Disability Index]. Med Clin (Barc). 2008 Feb 2;130(3):85-9. doi: 10.1157/13115352. Spanish.
PubMed 18261377Cuesta-Vargas AI, Roldan-Jimenez C, Neblett R, Gatchel RJ. Cross-cultural adaptation and validity of the Spanish central sensitization inventory. Springerplus. 2016 Oct 21;5(1):1837. doi: 10.1186/s40064-016-3515-4. eCollection 2016.
PubMed 27818875Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
PubMed 12216605Hafliethadottir SH, Juhl CB, Nielsen SM, Henriksen M, Harris IA, Bliddal H, Christensen R. Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects. Trials. 2021 Jul 26;22(1):493. doi: 10.1186/s13063-021-05454-8.
PubMed 34311793Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. doi: 10.1089/acm.2006.12.303.
PubMed 16646730Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
PubMed 15020033Rodriguez-Huguet M, Vinolo-Gil MJ, Gongora-Rodriguez J. Dry Needling in Physical Therapy Treatment of Chronic Neck Pain: Systematic Review. J Clin Med. 2022 Apr 23;11(9):2370. doi: 10.3390/jcm11092370.
PubMed 35566496
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06453408
- Acronym / sponsor ID
- PS-Leire
- Conditions
- Neck Pain
- Keywords
- dry needling, validation, placebo, neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 11 Jun 2024 (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 aims to validate a placebo dry needling protocol for patients with non-specific neck pain and investigate whether prior experience with dry needling affects their ability to distinguish between real and placebo treatments, and how this impacts outcomes. Seventy participants aged 18-65 will be recruited and divided into two groups based on their previous dry needling experience, then randomized into real or placebo needling groups.
Assessment will be carried out before treatment, immediately after the procedure and one week later. Pain intensity, pain threshold to pressure, cervical range of motion, level of disability and presence of central sensitisation will also be measured.
Detailed description
Background: There is currently no valid and reliable method available to perform a placebo dry needling protocol in patients with non-specific neck pain. The lack of uniformity and validity in placebo dry needling methods hinders research on the specific effects of this technique. In addition, there is no solid evidence on how patients' previous experiences affect their expectations of treatment. An effective placebo dry needling protocol is essential for future research on the effectiveness of dry needling in randomised controlled clinical trials.
Objective: The main objective of this study is to validate a placebo dry needling protocol. The secondary objective is to examine whether the patient's previous experience with dry needling influences their ability to discern between having received a real or placebo needling and how this impacts on the outcomes of the intervention.
Material and method: 70 participants aged 18-65 years with non-specific neck pain who meet the inclusion criteria will be recruited. They will be assigned to one of two groups, those who have previously received dry needling and those who have not. Thereafter, members of each group will be randomised and assigned to either the real dry needling or placebo group. Assessment will be carried out before treatment, immediately after the procedure and one week later. Pain intensity, pain threshold to pressure, cervical range of motion, level of disability and presence of central sensitisation will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo, sin experiencia | Sham comparator | Procedure: Punción seca con aguja retráctilGroup of patients with no previous experience in dry needling, will be given placebo dry needling |
| Placebo, con experiencia | Sham comparator | Procedure: Punción seca con aguja retráctilGroup of patients with previous experience in dry needling, will be given placebo dry needling |
| Real, sin experiencia | Experimental | Procedure: Punción seca con aguja normativa.Group of patients with no previous experience in dry needling, real dry needling will be applied |
| Real, con experiencia | Experimental | Procedure: Punción seca con aguja normativa.Group of patients with previous experience in dry needling, real dry needling will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-specific neck pain, unilateral or bilateral.
- Neck pain lasting ≥ 3 months.
- Presence of active myofascial trigger point (MTrP) in the upper trapezius muscle, left, right or bilateral, in relation to the patient's neck pain.
Key exclusion criteria (9 listed)
- Fear or phobia of needles
- Skin lesions, infection or inflammation in the area to be pricked
- Specific alterations of the cervical region in the medical history
- Coagulation disorders
- Surgical intervention of the cervical or anterior shoulder region
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 |
|---|---|---|
| Punción seca con aguja retráctilAlso: DONGBANG AcuPrime® de 0,30 x 30mm.The placebo dry needling protocol will be performed in the same position, with identical antiseptic measures and the same number of simulated incisions as the real dry needling protocol, using DONGBANG AcuPrime® 0.30 x 30mm blunt-tipped placebo needles with a retractable handle. These needles simulate the sensation of needle contact without penetrating the skin. The therapist will hold the needle and guide tube, pressing the tube against the skin and simulating needle manipulation. Changes in pressure direction will mimic the real technique. The protocol will end with compression using an alcohol swab and an upper trapezius stretch. Participants in both groups will receive the same information about the sensations of the dry needling procedure. At the beginning, they will be informed that they may or may not feel the needle insertion. They will also be told that the physiotherapist will manually manipulate the needle multiple times during the procedure. | Procedure or surgery | Placebo, con experiencia, Placebo, sin experiencia |
| Punción seca con aguja normativa.Also: APS Regular Agupunt 0,30 × 30 mmTo perform the actual SP, patients shall be asked to lie prone with arms close to the body. The dry needling shall be performed with a 0,30 × 30 mm DN needle (APS Regular Agupunt) with a guide tube. The therapist shall first clean the area with alcohol. The trapezius muscle is then firmly grasped with a clamp between the thumb and index finger, so that the needle is directed deep into the index finger until the tip of the needle is felt to be approaching (33). This procedure involves an approximate insertion of the needle to a depth of 30 mm and ensures the intramuscular penetration necessary for dry needling. Puncture of the PGM shall be performed using the Hong technique (34), performing up to 12 inlets and outlets, at a frequency of 1 Hz. When the needle is withdrawn, the area is firmly compressed with cotton wool for 60 seconds. Finally, the upper trapezius muscle is stretched, following the technique originally described by Simons (35). | Procedure or surgery | Real, con experiencia, Real, sin experiencia |
Primary outcome
Successful identification rate of group assignment
Time frame: Immediately after the intervention and one week later, in order to see if any participants change their response.
A Questionnaire of its own, designed to record participants' perceptions of the perceived intervention, will be used. Participants will be asked to select which group they believe they belong to by choosing one of five possible responses: 1. I strongly believe I was assigned to the treatment group. 2. I believe to some extent that I was assigned to the treatment group. 3. I believe to some extent that I was assigned to the control group. 4. I strongly believe that I was assigned to the control group. 5. I am not sure
5 secondary outcomes
Pain intensity
Time frame: Before and immediately after the intervention, and a new assessment will be carried out one week later.
Neck disability
Time frame: Before and one week after the intervention.
Cervical Range of Motion
Time frame: Before intervention, immediately after intervention and after one week.
central sensitisation
Time frame: Before the intervention and one week after
Pressure pain threshold
Time frame: Before the intervention, immediately after the intervention and one week afterwards
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 15850733Pariente J, White P, Frackowiak RS, Lewith G. Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage. 2005 May 1;25(4):1161-7. doi: 10.1016/j.neuroimage.2005.01.016.
- Background: PubMed 29228289Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.
- Background: PubMed 18467932Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
- Background: PubMed 18261377Andrade Ortega JA, Delgado Martinez AD, Almecija Ruiz R. [Validation of a Spanish version of the Neck Disability Index]. Med Clin (Barc). 2008 Feb 2;130(3):85-9. doi: 10.1157/13115352. Spanish.
- Background: PubMed 27818875Cuesta-Vargas AI, Roldan-Jimenez C, Neblett R, Gatchel RJ. Cross-cultural adaptation and validity of the Spanish central sensitization inventory. Springerplus. 2016 Oct 21;5(1):1837. doi: 10.1186/s40064-016-3515-4. eCollection 2016.
- Background: PubMed 12216605Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
- Background: PubMed 34311793Hafliethadottir SH, Juhl CB, Nielsen SM, Henriksen M, Harris IA, Bliddal H, Christensen R. Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects. Trials. 2021 Jul 26;22(1):493. doi: 10.1186/s13063-021-05454-8.
- Background: PubMed 16646730Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. doi: 10.1089/acm.2006.12.303.
- Background: PubMed 15020033Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
- Background: PubMed 35566496Rodriguez-Huguet M, Vinolo-Gil MJ, Gongora-Rodriguez J. Dry Needling in Physical Therapy Treatment of Chronic Neck Pain: Systematic Review. J Clin Med. 2022 Apr 23;11(9):2370. doi: 10.3390/jcm11092370.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Leire Vazquez-Casar principal investigator
University of Alcala
Questions about this trial
What is this clinical trial studying?
A study testing Punción seca con aguja retráctil and Punción seca con aguja normativa. in people with Neck Pain, run by University of Alcala.
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 9 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leire Vazquez-Casar (+34636219095, leire.vazquez@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful identification rate of group assignment (time frame: Immediately after the intervention and one week later, in order to see if any participants change their response.). 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 NCT06453408, which also lists 10 linked publications.
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 11 Jun 2024.