Patient Expectations and Dry Needling

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Device: Dry Needling; Device: Sham Needling

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

Contacts and Locations

Study Locations

• Spain
  • Rest Of The World
    • Alcorcón, Rest Of The World, Spain, 28922
      • César Fernández-de-las-Peñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling; The intervention group will receive real dry needling (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 the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited
Sham Comparator: Sham Needling; 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: Sham Needling; 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

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, immediately after and 1 week 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, immediately 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).	Baseline and 1 week after intervention

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• Gallego-Sendarrubias GM, Voogt L, Arias-Buria JL, Bialosky J, Fernandez-de-Las-Penas C. Can Patient Expectations Modulate the Short-Term Effects of Dry Needling on Sensitivity Outcomes in Patients with Mechanical Neck Pain? A Randomized Clinical Trial. Pain Med. 2022 May 4;23(5):965-976. doi: 10.1093/pm/pnab134.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 28, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 29, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neck Pain; Needling; Expectance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: URJC5006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No