Virtual Reality and Post-dry Needling Soreness

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788161
• Other study ID #: URJC1509201810418
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: April 26, 2021

Study information

• Verified date: April 2021
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 26, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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);

Related Conditions & MeSH terms

• Epicondylitis of the Elbow
• Healthy

Intervention

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

Locations

Country	Name	City	State
Spain	Cesar Fernandez-de-Las-Peñas	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	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
Secondary	Baseline data on pressure pain sensitivity assessed with a pressure algometer	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
Secondary	Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire	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
Secondary	Catastrophizing belief as assessed with the Pain Catastrophizing Scale	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