Clinical trial NCT03592095: Blinding and Previous Experiences of Dry Needling
Official title: Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Dry needling
Placebo
Myofascial pain syndrome
Blinding
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. These positive results are thought to be the consequence of specific neurophysiological and mechanical processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is still a topic of debate. This trial addresses one of the major methodological issues in needle testing,the effects of proper blinding. DN is a specific technique that is not easily be replaced by another comparable intervention. A sham needle with a blunt tip was created that simulates penetration into the skin without actually doing so. Research about a valid method for the control in needling studies is for this reason of particular relevance. A proper blinding technique is of importance to further the field of DN.

Detailed description: The objectives of this study are to analysize short-term effects on pain intensity and pressure pain sensitivity according to previous experience (blinding) in subjects with mechanical neck pain receiving real or sham-DN and to determine the success in masking DN versus sham DN in patients with mechanical neck pain based on prior experience with this technique.

Eligibility criteria: Inclusion Criteria:

* Non-specific mechanical neck pain of at least 3 months of duration
* Between 18-60 years old
* At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms

Exclusion Criteria:

* whiplash injury;
* previous cervical or thoracic surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone physical therapy in the previous 6 months;
* fear to needles

Primary outcomes:
measure: Changes in Neck Pain Intensity between baseline and follow-up periods
timeFrame: Baseline, inmediately after and 1 week after intervention
measure: Identification (blinding) of the needling intervention
timeFrame: Inmediately after intervention
Secondary outcomes:
measure: Changes in Pressure pain sensitivity between baseline and follow-up periods
timeFrame: Baseline, inmediately after and 1 week after intervention
measure: Changes in patients self-perceived improvement between baseline and follow-up periods
timeFrame: Baseline and 1 week after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gracia Gallego-Sendarrubias
state: Rest Of The World
Study officials:
References: