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Patient Expectations and Dry Needling

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling
Sham Needling
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Needling, Expectance

Eligibility Criteria

18 Months - 65 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • César Fernández-de-las-Peñas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry Needling

Sham Needling

Arm Description

The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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).

Full Information

First Posted
June 1, 2020
Last Updated
November 29, 2020
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT04417491
Brief Title
Patient Expectations and Dry Needling
Official Title
Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Needling, Expectance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.
Arm Title
Sham Needling
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dry Needling
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Needling
Intervention Description
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 Outcome Measure Information:
Title
Changes in Neck Pain Intensity between baseline and follow-up periods
Description
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).
Time Frame
Baseline, immediately after and 1 week after intervention
Secondary Outcome Measure Information:
Title
Changes in Pressure pain sensitivity between baseline and follow-up periods
Description
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)
Time Frame
Baseline, immediately after and 1 week after intervention
Title
Changes in patients self-perceived improvement between baseline and follow-up periods
Description
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).
Time Frame
Baseline and 1 week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
César Fernández-de-las-Peñas
City
Alcorcón
State/Province
Rest Of The World
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33830234
Citation
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.
Results Reference
derived

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Patient Expectations and Dry Needling

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