Skip to main content
OpenTrials
Completed

NCT Number: NCT04417491

Patient Expectations and Dry Needling

Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 month–65 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

César Fernández-de-las-Peñas

Alcorcón, Rest of the World, 28922, Spain

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
  • 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 the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited

Sham Needling

Device

Sham dry needling with be conducted with a sham needle device. 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, immediately 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).

Secondary outcomes

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

    Time frame: Baseline, immediately 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).

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Dec 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.