NCT03788161

Brief Summary

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Previous studies have investigated spray and stretch, ischemic compression or low-load eccentric exercise as post-needling intervention procedures. There is increasing evidence supporting the role of descending pain inhibition mechanisms for paon control. The application of virtual reality as a distraction technique could active brain mechanisms during dry needling. Therefore, the objective of this study will be to investigate the effects of playing virtual reality during the application of dry needling on post-needling soreness over trigger points in the extensor carpi radialis brevis muscle. A secondary aim will be to determine the prognostic role of baseline scores of pressure pain sensitivity, related-disability, anxiety and catastrophizing levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

December 22, 2018

Last Update Submit

April 26, 2021

Conditions

HealthyEpicondylitis of the Elbow

Keywords

trigger pointsvirtual realityDry needling

Outcome Measures

Primary Outcomes (1)

  • Changes in post-dry needling pain assessed with a numerical pain rate scale before and after the intervention

    A numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain

    Baseline, 5 minutes after, 12 hours after, 24 hours after, 36 hours after, 48 hours after, and 72 hours after treatment

Secondary Outcomes (4)

  • Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    Baseline

  • Baseline data on pressure pain sensitivity assessed with a pressure algometer

    Baseline

  • Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire

    Baseline

  • Catastrophizing belief as assessed with the Pain Catastrophizing Scale

    Baseline

Study Arms (2)

Real Virtual Reality

EXPERIMENTAL

Participants will receive a distraction by playing a game of virtual reality with a 3D application

Other: Real Virtual Reality

Placebo Virtual Reality

PLACEBO COMPARATOR

Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning

Other: Placebo Virtual Reality

Interventions

Real Virtual RealityOTHER

Participants will receive a distraction by playing a game of virtual reality with a 3D application

Real Virtual Reality
Placebo Virtual RealityOTHER

Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning

Placebo Virtual Reality

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no history of upper quadrant pain symptoms the year preceding the study
  • no history of upper quadrant surgery
  • presence of a latent trigger point in the extensor carpi radialis brevis muscle
  • pain over the lateral side of the elbow;
  • pain on palpation over the lateral epicondyle or the associated common wrist extensor tendon;
  • elbow pain with either resisted static contraction or stretching of the wrist extensor muscles.
  • presence of an active trigger point in the extensor carpi radialis brevis muscle

You may not qualify if:

  • bilateral symptoms;
  • older than 50 years of age;
  • previous surgery or steroid injections;
  • other diagnoses of upper extremity (shoulder pathology, cervical radiculopathy, cervical whiplash);
  • history of cervical or upper extremity trauma;
  • history of musculoskeletal medical conditions (rheumatoid arthritis, fibromyalgia);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

December 22, 2018

First Posted

December 27, 2018

Study Start

January 15, 2019

Primary Completion

March 15, 2021

Study Completion

April 26, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

ES(1)