NCT06288048

Brief Summary

The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are:

  • Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity?
  • Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold?
  • Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght? Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength. Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy. Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 23, 2024

Last Update Submit

February 29, 2024

Conditions

Keywords

Mirror Therapy; Dry Needling; Post-Needling Pain; Myofascial Trigger Point

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    Pain intensity refers to the subjective level of discomfort or suffering experienced by an individual due to pain. It will be measured in Visual Analogue Scale (VAS).

    From before and after the intervention until the conclusion of treatment at the 1-hour.

  • Pain pressure threshold

    The pain pressure threshold refers to the amount of pressure or force applied to a specific area of the body before the sensation of pain is experienced. It is commonly used in medical evaluations to assess pain sensitivity and tolerance. It will be measured in PPT (Kg/cm2)

    From before and after the intervention until the conclusion of treatment at the 1-hour.

  • Two-point discrimination threshold

    The two-point discrimination threshold refers to the ability of an individual to perceive two separate points of contact on the skin as distinct from a single point. It will be measured in 2-point discriminator 12-1480 skin caliper Baseline®.

    From before and after the intervention until the conclusion of treatment at the 1-hour.

  • Maximum hand grip strength

    Maximum hand grip strength refers to the maximum force that an individual can exert when squeezing an object with their hand muscles. It will be measured JAMAR® Hand Dynamometer J00105.

    From before and after the intervention until the conclusion of treatment at the 1-hour.

Study Arms (2)

Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT

EXPERIMENTAL

The intervention protocol in this study will target individuals experiencing Post-needling pain associated with lateral elbow pain. It will comprise a series of treatments including Deep Dry Needling (DDN) focused on the proximal third of the m. Brachioradialis (BR), was conducted with the patient seated and the therapist positioned on the same side as the needle insertion. Following DDN, ischemic compression (IC) will be applied using a sphygmomanometer on the seated subject's arm, along with three applications of cold spray synchronized with m. Brachioradialis (BR) stretching. The intervention will conclude with Mirror Therapy (MFT), where the patient will face a mirror covering the punctured side at a 45-degree angle for proper hand visualization, engaging in hand exercises and wrist movements while observing their reflection.

Procedure: Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT

Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching

ACTIVE COMPARATOR

The intervention protocol in this study will target individuals experiencing Post-needling pain associated with lateral elbow pain. It will comprise a series of treatments including Deep Dry Needling (DDN) focused on the proximal third of the m. Brachioradialis (BR), conducted with the patient seated and the therapist positioned on the same side as the needle insertion. Following DDN, ischemic compression (IC) will be applied using a sphygmomanometer on the seated subject's arm, along with three applications of cold spray synchronized with m. Brachioradialis (BR) stretching. The intervention will not conclude with Mirror Therapy (MFT).

Procedure: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching

Interventions

Experimental: Target: Proximal third of m. Brachioradialis (BR) Patient position: Seated Therapist position: Same side as needle insertion Needle insertion direction: Lateral-to-medial towards clinician\'s finger Needle type: AguPunt® Barcelona, Spain Technique: Seek three local twitch responses in m. Brachioradialis (BR) Alternative for no responses: 10 needle insertions and withdrawals at 1 Hz frequency Ischemic Compression (IC): Applied using sphygmomanometer on seated subject\'s arm Pressure: Increased until ischemic pain (approx. 200 mmHg) Duration: Maintained for 90 seconds Combined with three applications of Cryos Phyto Performance 400 ml cold spray synchronized with m. Brachioradialis (BR) stretching: Stretching: Passive sustained mobilization with elbow extension and forearm pronation for 10 seconds Mirror Therapy (MFT): Setup: Patient seated with forearms resting on bed Mirror: 35 x 35 cm, covering punctured side at 45-degree angle for hand visualization

Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT

The intervention protocol in this study will target individuals experiencing Post-needling pain associated with lateral elbow pain. It will comprise a series of treatments including Deep Dry Needling (DDN) focused on the proximal third of the m. Brachioradialis (BR), conducted with the patient seated and the therapist positioned on the same side as the needle insertion. Following DDN, ischemic compression (IC) will be applied using a sphygmomanometer on the seated subject\'s arm, along with three applications of cold spray synchronized with m. Brachioradialis (BR) stretching. The intervention will not conclude with Mirror Therapy (MFT).

Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals males and females aged 18 years or older
  • Individuals suffering from lateral elbow myofascial pain diagnosed by either a GP or physical therapist
  • for less than 3 months
  • lacking a history of severe trauma
  • Individuals not having any prior exposure to Dry Needling treatment
  • Individuals not currently using relevant medications

You may not qualify if:

  • Individuals under the age of 18
  • Individuals not diagnosed with lateral elbow myofascial pain by either a GP or physical therapist
  • Individuals experiencing lateral elbow myofascial pain for more than 3 months
  • Individuals with a history of severe trauma to the affected area
  • Individuals who have previously undergone Dry Needling treatment for their lateral elbow myofascial pain
  • Individuals currently using medications relevant to the treatment of lateral elbow myofascial pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Canarias

La Orotava, Santa Cruz De Tenerife, 38300, Spain

Location

Related Publications (1)

  • Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.

MeSH Terms

Interventions

dendrinAcupressureD-4-chloro-17 beta-hydroxy-3-oxo-17 alpha-methylandrosta-1,4-diene

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation and data assessor were blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-Time Professor

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

April 1, 2023

Primary Completion

March 7, 2024

Study Completion

June 30, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Results should not be shared, although they will be available to reviewers upon request.

Locations