Patient Expectations and Dry Needling

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417491
• Other study ID #: URJC5006
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: November 28, 2020

Study information

• Verified date: November 2020
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 28, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 65 Months

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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 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

Locations

Country	Name	City	State
Spain	César Fernández-de-las-Peñas	Alcorcón	Rest Of The World

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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