- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03788161
Virtual Reality and Post-dry Needling Soreness
April 26, 2021 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Effects of Virtual Reality on Post-Needling Soreness After Dry Needling of Trigger Points in the Extensor Carpi Radialis Brevis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Alcorcon, Madrid, Spain, 28921
- César Fernández-de-las-Peñas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for pain-free participants:
- 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
Inclusion criteria for patients with elbow pain:
- 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
Exclusion Criteria:
- 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);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real Virtual Reality
Participants will receive a distraction by playing a game of virtual reality with a 3D application
|
Participants will receive a distraction by playing a game of virtual reality with a 3D application
|
Placebo Comparator: Placebo Virtual Reality
Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
|
Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in post-dry needling pain assessed with a numerical pain rate scale before and after the intervention
Time Frame: Baseline, 5 minutes after, 12 hours after, 24 hours after, 36 hours after, 48 hours after, and 72 hours after treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Baseline
|
The DASH questionaire consists of 30-items assessing: 1, degree of difficulty during the preceding week in performing physical activities because of problems in the upper extremity (21 items); 2, severity of each pain symptom, activity-related pain, tingling, weakness, and stiffness (5 items); and, 3, the problem's effect on social activities, work, and sleep, and its psychological impact (4 items).
Each item is answered on a 5-points scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact).
Responses are summed to form a raw score that is converted to a 0 to 100 scale where higher scores reflect greater related-disability.
|
Baseline
|
Baseline data on pressure pain sensitivity assessed with a pressure algometer
Time Frame: Baseline
|
Pressure pain thresholds over the cervical spine, the lateral epicondyle and the tibialis anterior muscle will be assessed with a pressure algometer at baseline
|
Baseline
|
Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire
Time Frame: Baseline
|
The STAI is a 40 items scale assessing separate dimensions of state anxiety (items l-20, STAI-S) and trait anxiety (items 21-40, STAI-T).
The STAI-S items assess relatively enduring symptoms of anxiety.
Participants use a 4-points response scale ranging from "not at all" to "very much", to indicate the extent to which they experience each emotion.
The STAI-T scale measures a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening.
It consists of 20 statements requiring individuals to rate how they generally feel on a 4-points scale.
In both scales, higher scores indicate greater state or trait anxiety.
|
Baseline
|
Catastrophizing belief as assessed with the Pain Catastrophizing Scale
Time Frame: Baseline
|
The Pain Catastrophizing Scale will be used for determining baseline participant's propensity to catastrophize about pain.
It consists of 13-items evaluating the three components of catastrophizing: rumination, magnification and helplessness.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2019
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
April 26, 2021
Study Registration Dates
First Submitted
December 22, 2018
First Submitted That Met QC Criteria
December 26, 2018
First Posted (Actual)
December 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- URJC1509201810418
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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