HealthyNCT03788161
Virtual Reality and Post-dry Needling Soreness
A study testing Real Virtual Reality in people with Healthy and Epicondylitis of the Elbow, run by Universidad Rey Juan Carlos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Epicondylitis of the Elbow
- What is being tested?
- Real Virtual Reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 26 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy, Epicondylitis of the Elbow
- Being tested
- Real Virtual Reality, Placebo Virtual Reality
- Keywords
- trigger points, virtual reality, Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Virtual RealityOther
Participants will receive a distraction by playing a game of virtual reality with a 3D application
Placebo Virtual RealityOther
Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
| Study group | Role | What they receive |
|---|---|---|
| Real Virtual Reality | Experimental | Participants will receive a distraction by playing a game of virtual reality with a 3D application Receives: 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 Receives: Other: Placebo Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start15 Jan 2019
- Primary completion15 Mar 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788161
- Sponsor's protocol ID
- URJC1509201810418
- Status last verified
- Apr 2021
- First submitted
- 22 Dec 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Post-Needling Soreness After Dry Needling of Trigger Points in the Extensor Carpi Radialis Brevis
- ClinicalTrials.gov ID
- NCT03788161
- Acronym / sponsor ID
- URJC1509201810418
- Conditions
- Healthy, Epicondylitis of the Elbow
- Keywords
- trigger points, virtual reality, Dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Virtual Reality | Experimental | Other: Real Virtual RealityParticipants will receive a distraction by playing a game of virtual reality with a 3D application |
| Placebo Virtual Reality | Placebo comparator | Other: Placebo Virtual RealityParticipants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real Virtual RealityParticipants will receive a distraction by playing a game of virtual reality with a 3D application | Other | Real Virtual Reality |
| Placebo Virtual RealityParticipants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning | Other | Placebo Virtual Reality |
Primary outcome
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
4 secondary outcomes
Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline
Baseline data on pressure pain sensitivity assessed with a pressure algometer
Time frame: Baseline
Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire
Time frame: Baseline
Catastrophizing belief as assessed with the Pain Catastrophizing Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Virtual Reality in people with Healthy and Epicondylitis of the Elbow, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.