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

University of Alcala

Status: Not yet enrolling

Conditions: Neck Pain

Treatments: Procedure: Punción seca con aguja normativa.; Procedure: Punción seca con aguja retráctil

Study type: Interventional

Funder types: Other

Identifiers

NCT06453408

PS-Leire

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 4 patient groups

Placebo, sin experiencia

Sham Comparator group

Description:

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

Treatment:

Procedure: Punción seca con aguja retráctil

Placebo, con experiencia

Sham Comparator group

Description:

Group of patients with previous experience in dry needling, will be given placebo dry needling

Treatment:

Procedure: Punción seca con aguja retráctil

Real, sin experiencia

Experimental group

Description:

Group of patients with no previous experience in dry needling, real dry needling will be applied

Treatment:

Procedure: Punción seca con aguja normativa.

Real, con experiencia

Experimental group

Description:

Group of patients with previous experience in dry needling, real dry needling will be applied.

Treatment:

Procedure: Punción seca con aguja normativa.