Blinding and Previous Experiences of Dry Needling

NCT03592095 | Completed DMC

• 1 other identifier: Hulp:5006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

Dry needling; Placebo; Myofascial pain syndrome; Blinding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Baseline, inmediately after and 1 week after intervention

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

  Baseline and 1 week after intervention

Study Arms (2)

DN group

EXPERIMENTAL

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

Placebo needle

PLACEBO COMPARATOR

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

Interventions

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

DN group

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.

Placebo needle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

Gracia Gallego-Sendarrubias

Madrid, Rest of the World, 28922, Spain

Location

MeSH Terms

Conditions

Neck Pain; Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 19, 2018
• Study Start: June 4, 2020
• Primary Completion: November 2, 2020
• Study Completion: December 10, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

ES (1)