Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain

NCT06453408 | Not Yet Recruiting

• 1 other identifier: PS-Leire
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Neck Pain

Keywords

dry needling; validation; placebo; neck pain

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Immediately after the intervention and one week later, in order to see if any participants change their response.

Secondary Outcomes (5)

• Pain intensity

  Before and immediately after the intervention, and a new assessment will be carried out one week later.

• Neck disability

  Before and one week after the intervention.

• Cervical Range of Motion

  Before intervention, immediately after intervention and after one week.

• central sensitisation

  Before the intervention and one week after

• Pressure pain threshold

  Before the intervention, immediately after the intervention and one week afterwards

Study Arms (4)

Placebo, sin experiencia

SHAM COMPARATOR

Group of patients with no previous experience in dry needling, will be given placebo dry needling

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

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

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.

Procedure: Punción seca con aguja normativa.

Interventions

Punción seca con aguja retráctil PROCEDURE

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.

Also known as: DONGBANG AcuPrime® de 0,30 x 30mm.

Placebo, con experiencia; Placebo, sin experiencia

Punción seca con aguja normativa. PROCEDURE

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).

Also known as: APS Regular Agupunt 0,30 × 30 mm

Real, con experiencia; Real, sin experiencia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Alcala: lead

Related Publications (10)

• 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.

  PMID: 15850733 BACKGROUND

• Bier 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.

  PMID: 29228289 BACKGROUND

• Boonstra 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.

  PMID: 18467932 BACKGROUND

• Andrade 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.

  PMID: 18261377 BACKGROUND

• Cuesta-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.

  PMID: 27818875 BACKGROUND

• Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.

  PMID: 12216605 BACKGROUND

• Hafliethadottir 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.

  PMID: 34311793 BACKGROUND

• Birch 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.

  PMID: 16646730 BACKGROUND

• Bang 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.

  PMID: 15020033 BACKGROUND

• Rodriguez-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.

  PMID: 35566496 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leire Vazquez-Casar

  University of Alcala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leire Vazquez-Casar

CONTACT

+34636219095; leire.vazquez@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leire Vázquez Casar

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 25, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share