PainNCT06448104
Virtual Reality in Invasive Techniques in Physiotherapy
A study testing Dry needling and immersive virtual reality and Dry needling in people with Pain, run by University of Valencia at 1 site in Spain.
Trial summary
Dry needling is a common physical therapy technique that uses solid acupuncture needles that are repeatedly inserted and removed into the human body. These techniques, despite their benefits, can cause pain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Dry needling and immersive virtual reality and Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2024to 6 Feb 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have at least one identifiable latent myofascial trigger point in the muscles studied
Who cannot join
- Suffer any musculoskeletal or neural alteration that could alter the results obtained
- Suffer from belonephobia or extreme and uncontrollable fear of sharp objects
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, 46020
About this study
Official title: Effect of Immersive Virtual Reality as a Distraction Tool to Reduce Pain and Discomfort Associated With Dry Needling Application
Dry needling is a common physical therapy technique that uses solid acupuncture needles that are repeatedly inserted and removed into the human body. These techniques, despite their benefits, can cause pain. The objective of this study is to analyze the use of virtual reality as a distractor in invasive techniques in physiotherapy. The hypothesis is that the use of immersive virtual reality, evoking relaxation situations, will reduce the sensation of pain during and/or after the technique. To do this, healthy participants will be recruited and the participants will be divided into two groups (experimental and control). Participants in the experimental group will undergo the dry needling technique on latent myofascial trigger points along with the use of immersive virtual reality. The same technique will be performed on participants in the control group but without the use of virtual reality. Pain during and after puncture and strength after puncture will be evaluated.
- Conditions
- Pain
- Being tested
- Dry needling and immersive virtual reality, Dry needling
- Keywords
- pain, dry needling, virtual reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling and immersive virtual realityOther
The study consists of two sessions, separated by a period of two weeks. In the first session, a dry needling procedure based on the Hong technique is performed on the main latent myofascial trigger point of the medial gastrocnemius, vastus medialis quadriceps or biceps femoris muscles.
The procedure will be carried out simultaneously with the use of immersive virtual reality distraction software, applied through MetaQuest 2 virtual reality glasses. This procedure consists of immersive visualization (video and sound images that represent scenes related to relaxation).
In the second session, the same procedure will be repeated, with the addition that the participants will perform 3 sets of 10 repetitions (12RM intensity) of the plantar flexion exercises prior to performing the dry needling technique. of ankle, knee extension or knee flexion (depending on the muscle evaluated) with the aim of stimulating the area to be evaluated, simulating post-exercise fatigue.
Dry needlingOther
The study consists of two sessions, separated by a period of two weeks. In the first session, a dry needling procedure based on the Hong technique is performed on the main latent myofascial trigger point of the medial gastrocnemius, vastus medialis quadriceps or biceps femoris muscles.
In the second session, the same procedure will be repeated, with the addition that the participants will perform 3 sets of 10 repetitions (12RM intensity) of the plantar flexion exercises prior to performing the dry needling technique. of ankle, knee extension or knee flexion (depending on the muscle evaluated) with the aim of stimulating the area to be evaluated, simulating post-exercise fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling and immersive virtual reality | Experimental | Participants assigned to "Dry needling and immersive virtual reality" group will carry out a first session in which the dry needling technique will be performed together with immersive virtual reality and the results will be recorded. Likewise, after two weeks, these participants will repeat the dry needling session (with virtual reality) and evaluation, adding a previous exercise session. Receives: Other: Dry needling and immersive virtual reality |
| Standard dry needling | Active comparator | Participants assigned to "Standard dry needling" group will undergo a first session in which the dry needling technique will be performed and the results will be recorded. After two weeks, these participants will repeat the dry needling and evaluation session, in this case adding a previous exercise session. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during dry needling
Pain perception during dry needling technique measured using a numerical pain rating scale (0-10)
Measured: Immediately after technique application in each session (two sessions separated by two weeks)
Secondary outcomes (3)
Pain after dry needling
Pain after dry needling technique measured using a numerical pain rating scale (0-10)
Measured: Immediately after technique application; 30 minutes after technique application; 1 hour after technique application; 6 hours after technique application; 24 hours after technique application in each session (two sessions separated by two weeks)
Pain pressure threshold
Pain pressure threshold measured using an algometer
Measured: Before technique; Immediately after technique; 30 minutes after technique; 60 minutes after technique in each session (two sessions separated by two weeks)
Strength
Strength measured using a hand-held dynamometer
Measured: Before technique; Immediately after technique in each session (two sessions separated by two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start3 Sep 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
- Investigators
- Rodrigo Martín-San Agustín, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448104
- Sponsor's protocol ID
- 3250436
- Status last verified
- Apr 2025
- First submitted
- 31 May 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality as a Distraction Tool to Reduce Pain and Discomfort Associated With Dry Needling Application
- ClinicalTrials.gov ID
- NCT06448104
- Acronym / sponsor ID
- 3250436
- Conditions
- Pain
- Keywords
- pain, dry needling, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 7 Jun 2024 (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.
Dry needling is a common physical therapy technique that uses solid acupuncture needles that are repeatedly inserted and removed into the human body. These techniques, despite their benefits, can cause pain. The objective of this study is to analyze the use of virtual reality as a distractor in invasive techniques in physiotherapy. The hypothesis is that the use of immersive virtual reality, evoking relaxation situations, will reduce the sensation of pain during and/or after the technique. To do this, healthy participants will be recruited and the participants will be divided into two groups (experimental and control). Participants in the experimental group will undergo the dry needling technique on latent myofascial trigger points along with the use of immersive virtual reality. The same technique will be performed on participants in the control group but without the use of virtual reality. Pain during and after puncture and strength after puncture will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling and immersive virtual reality | Experimental | Other: Dry needling and immersive virtual realityParticipants assigned to "Dry needling and immersive virtual reality" group will carry out a first session in which the dry needling technique will be performed together with immersive virtual reality and the results will be recorded. Likewise, after two weeks, these participants will repeat the dry needling session (with virtual reality) and evaluation, adding a previous exercise session. |
| Standard dry needling | Active comparator | Other: Dry needlingParticipants assigned to "Standard dry needling" group will undergo a first session in which the dry needling technique will be performed and the results will be recorded. After two weeks, these participants will repeat the dry needling and evaluation session, in this case adding a previous exercise session. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Have at least one identifiable latent myofascial trigger point in the muscles studied
Key exclusion criteria (2 listed)
- Suffer any musculoskeletal or neural alteration that could alter the results obtained
- Suffer from belonephobia or extreme and uncontrollable fear of sharp objects
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 |
|---|---|---|
| Dry needling and immersive virtual realityThe study consists of two sessions, separated by a period of two weeks. In the first session, a dry needling procedure based on the Hong technique is performed on the main latent myofascial trigger point of the medial gastrocnemius, vastus medialis quadriceps or biceps femoris muscles. The procedure will be carried out simultaneously with the use of immersive virtual reality distraction software, applied through MetaQuest 2 virtual reality glasses. This procedure consists of immersive visualization (video and sound images that represent scenes related to relaxation). In the second session, the same procedure will be repeated, with the addition that the participants will perform 3 sets of 10 repetitions (12RM intensity) of the plantar flexion exercises prior to performing the dry needling technique. of ankle, knee extension or knee flexion (depending on the muscle evaluated) with the aim of stimulating the area to be evaluated, simulating post-exercise fatigue. | Other | Dry needling and immersive virtual reality |
| Dry needlingThe study consists of two sessions, separated by a period of two weeks. In the first session, a dry needling procedure based on the Hong technique is performed on the main latent myofascial trigger point of the medial gastrocnemius, vastus medialis quadriceps or biceps femoris muscles. In the second session, the same procedure will be repeated, with the addition that the participants will perform 3 sets of 10 repetitions (12RM intensity) of the plantar flexion exercises prior to performing the dry needling technique. of ankle, knee extension or knee flexion (depending on the muscle evaluated) with the aim of stimulating the area to be evaluated, simulating post-exercise fatigue. | Other | Standard dry needling |
Primary outcome
Pain during dry needling
Time frame: Immediately after technique application in each session (two sessions separated by two weeks)
Pain perception during dry needling technique measured using a numerical pain rating scale (0-10)
3 secondary outcomes
Pain after dry needling
Time frame: Immediately after technique application; 30 minutes after technique application; 1 hour after technique application; 6 hours after technique application; 24 hours after technique application in each session (two sessions separated by two weeks)
Pain pressure threshold
Time frame: Before technique; Immediately after technique; 30 minutes after technique; 60 minutes after technique in each session (two sessions separated by two weeks)
Strength
Time frame: Before technique; Immediately after technique in each session (two sessions separated by two weeks)
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 4 May 2025.
- Individual participant dataSharing planned: No
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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.
Rodrigo Martín-San Agustín, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and immersive virtual reality and Dry needling in people with Pain, run by University of Valencia 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 1 inclusion and 2 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 4 May 2025. 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. 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?
Pain during dry needling (time frame: Immediately after technique application in each session (two sessions separated by two weeks)). 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 4 May 2025.