Virtual Reality in Invasive Techniques in Physiotherapy

April 29, 2025 updated by: Rodrigo Martín-San-Agustin, University of Valencia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Valencia, Spain, 46020
        • Faculty of Physiotherapy, University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have at least one identifiable latent myofascial trigger point in the muscles studied

Exclusion Criteria:

  • Suffer any musculoskeletal or neural alteration that could alter the results obtained
  • Suffer from belonephobia or extreme and uncontrollable fear of sharp objects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling and immersive virtual reality
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.
Other: Dry needling and immersive virtual reality

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.
Active Comparator: Standard dry needling
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.
Other: Dry needling

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Immediately after technique application in each session (two sessions separated by two weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 after dry needling technique measured using a numerical pain rating scale (0-10)
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)
Pain pressure threshold measured using an algometer
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)
Strength measured using a hand-held dynamometer
Before technique; Immediately after technique in each session (two sessions separated by two weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo Martín-San Agustín, PhD, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3250436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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