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Completed

NCT Number: NCT03788161

Virtual Reality and Post-dry Needling Soreness

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.

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Key information

Conditions

Healthy Epicondylitis of the Elbow

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Real Virtual Reality

Other

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

Placebo virtual reality

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effects of Virtual Reality on Post-Needling Soreness After Dry Needling of Trigger Points in the Extensor Carpi Radialis Brevis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 27, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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