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Completed

NCT Number: NCT03592095

Blinding and Previous Experiences of Dry Needling

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.

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Key information

Conditions

Neck Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gracia Gallego-Sendarrubias

Madrid, Rest of the World, 28922, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Device

Real dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited

placebo needle

Device

Sham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient.

Primary outcomes

  1. Changes in Neck Pain Intensity between baseline and follow-up periods

    Time frame: Baseline, inmediately after and 1 week after intervention

    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).

  2. Identification (blinding) of the needling intervention

    Time frame: Inmediately after 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).

Secondary outcomes

  1. Changes in Pressure pain sensitivity between baseline and follow-up periods

    Time frame: Baseline, inmediately after and 1 week after intervention

    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)

  2. Changes in patients self-perceived improvement between baseline and follow-up periods

    Time frame: Baseline and 1 week after intervention

    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

Sponsors and collaborators

Lead sponsor

European University of Madrid

Other

Registry information

Official study title

Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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