Blinding and Previous Experiences of Dry Needling

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Device: Dry needling; Device: Placebo needle

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Rest Of The World
    • Madrid, Rest Of The World, Spain, 28922
      • Gracia Gallego-Sendarrubias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DN group; The intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.	Device: Dry needling; 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 Comparator: Placebo needle; 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.	Device: Placebo needle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: European University of Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dry needling; Placebo; Myofascial pain syndrome; Blinding
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Hulp:5006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No