NCT06448104

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

May 31, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

paindry needlingvirtual reality

Outcome Measures

Primary Outcomes (1)

  • Pain during dry needling

    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 Outcomes (3)

  • Pain after dry needling

    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

    Before technique; Immediately after technique; 30 minutes after technique; 60 minutes after technique in each session (two sessions separated by two weeks)

  • Strength

    Before technique; Immediately after technique in each session (two sessions separated by two weeks)

Study Arms (2)

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.

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.

Other: Dry needling

Interventions

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 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. 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.

Standard dry needling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, Valencia, 46020, Spain

Location

MeSH Terms

Conditions

Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Rodrigo Martín-San Agustín, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 7, 2024

Study Start

September 3, 2024

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations