Neck Pain Clinical Trial
Official title:
Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial
Verified date | December 2020 |
Source | European University of Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 10, 2020 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Gracia Gallego-Sendarrubias | Madrid | Rest Of The World |
Lead Sponsor | Collaborator |
---|---|
European University of Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Neck Pain Intensity between baseline and follow-up periods | The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS). | Baseline, inmediately after and 1 week after intervention | |
Primary | Identification (blinding) of the needling intervention | Participants will be asked directly after the intervention whether they thought they had received a real intervention or a sham. Answering categories were: 'yes' (real DN) or 'no' (sham DN). | Inmediately after intervention | |
Secondary | Changes in Pressure pain sensitivity between baseline and follow-up periods | Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel) | Baseline, inmediately after and 1 week after intervention | |
Secondary | Changes in patients self-perceived improvement between baseline and follow-up periods | Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively |
Baseline and 1 week after intervention |
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