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

NCT06453408 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-06-11

No results posted yet for this study

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

Interventions

PROCEDURE

Punción seca con aguja retráctil

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

Punción seca con aguja normativa.

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).

Sponsors & Collaborators

  • University of Alcala

    lead OTHER

Principal Investigators

  • Leire Vazquez-Casar · University of Alcala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2024-07-31
Completion
2024-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453408 on ClinicalTrials.gov