Neck Pain
Conditions
Keywords
dry needling, validation, placebo, neck pain
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.
Interventions
PROCEDUREPunción 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.
PROCEDUREPunción 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
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful identification rate of group assignment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Before and immediately after the intervention, and a new assessment will be carried out one week later. | Visual Analogic Scale |
| Neck disability | Before and one week after the intervention. | neck disability index |
| Cervical Range of Motion | Before intervention, immediately after intervention and after one week. | Grades |
| central sensitisation | Before the intervention and one week after | The Central Sensitisation Inventory (CSI) |
| Pressure pain threshold | Before the intervention, immediately after the intervention and one week afterwards | kg/sec |
Contacts
Primary ContactLeire Vazquez-Casar
Outcome results
None listed