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Virtual Reality and Post-dry Needling Soreness

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ClinicalTrials.gov Identifier: NCT03788161
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

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.

Condition or disease Intervention/treatment Phase
Healthy Epicondylitis of the Elbow Other: Real Virtual Reality Other: Placebo Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Virtual Reality on Post-Needling Soreness After Dry Needling of Trigger Points in the Extensor Carpi Radialis Brevis
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Real Virtual Reality
Participants will receive a distraction by playing a game of virtual reality with a 3D application
Other: Real Virtual Reality
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
Other: Placebo Virtual Reality
Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788161


Contacts
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Contact: César Fernández-de-las-Peñas 914888884 cesarfdlp@yahoo.es

Locations
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Spain
Cesar Fernandez-de-Las-Peñas Recruiting
Alcorcon, Madrid, Spain, 28921
Contact: CESAR FERNANDEZ-DE-LAS-PEÑAS, PhD    + 34 91 488 88 84    cesar.fernandez@urjc.es   
Sponsors and Collaborators
Universidad Rey Juan Carlos

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Responsible Party: César Fernández-de-las-Peñas, Director of Department, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT03788161     History of Changes
Other Study ID Numbers: URJC1509201810418
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

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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, Universidad Rey Juan Carlos:
trigger points
virtual reality
Dry needling