Patient Expectations and Dry Needling

Sponsor
Universidad Rey Juan Carlos (Other)
Overall Status
Completed
CT.gov ID
NCT04417491
Collaborator
(none)
50
1
2
5.8
8.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dry Needling
  • Device: Sham Needling
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain
Actual Study Start Date :
Jun 5, 2020
Actual Primary Completion Date :
Nov 2, 2020
Actual Study Completion Date :
Nov 28, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in Neck Pain Intensity between baseline and follow-up periods [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 65 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 César Fernández-de-las-Peñas Alcorcón Rest Of The World Spain 28922

Sponsors and Collaborators

  • Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
César Fernández-de-las-Peñas, Full Proffessor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT04417491
Other Study ID Numbers:
  • URJC5006
First Posted:
Jun 4, 2020
Last Update Posted:
Dec 1, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by César Fernández-de-las-Peñas, Full Proffessor, Universidad Rey Juan Carlos
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2020