Clinical trial NCT06453408: Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain
Official title: Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: dry needling
validation
placebo
neck pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful identification rate of group assignment
timeFrame: Immediately after the intervention and one week later, in order to see if any participants change their response.
Secondary outcomes:
measure: Pain intensity
timeFrame: Before and immediately after the intervention, and a new assessment will be carried out one week later.
measure: Neck disability
timeFrame: Before and one week after the intervention.
measure: Cervical Range of Motion
timeFrame: Before intervention, immediately after intervention and after one week.
measure: central sensitisation
timeFrame: Before the intervention and one week after
measure: Pressure pain threshold
timeFrame: Before the intervention, immediately after the intervention and one week afterwards
Other outcomes:
Locations:
Study officials:
affiliation: University of Alcala
name: Leire Vazquez-Casar
role: PRINCIPAL_INVESTIGATOR
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