Blinding and Previous Experiences of Dry Needling

European University

Status: Completed

Conditions: Neck Pain

Treatments: Device: Dry needling; Device: Placebo needle

Study type: Interventional

Funder types: Other

Identifiers

NCT03592095

Hulp:5006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

DN group

Experimental group

Description:

The intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.

Treatment:

Device: Dry needling

Placebo needle

Placebo Comparator group

Description:

The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.

Treatment:

Device: Placebo needle