A Phase 2/3 interventional study of Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT and Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching in Lateral Elbow Pain, sponsored by Universidad Europea de Canarias. Active, not recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Universidad Europea de Canarias · Phase 2/3, Interventional, and Treatment
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:
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.
This randomized, controlled pilot trial aims 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 study will enroll a total of 49 participants, with 23 females and 26 males, who will be randomly allocated to either the Experimental Group or the Control Group. The Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy, while the Control Group will not receive Mirror Visual Feedback Therapy. This random allocation is intended to minimize bias and enhance the internal validity of the study.
Pre- and post-treatment evaluations will include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength. Intergroup analysis will be conducted to determine if there is a statistically significant reduction in Post-needling pain intensity favoring the Experimental Group. Additionally, intragroup analysis will assess whether there are significant improvements in pressure pain threshold solely within the Experimental Group following the intervention.
The findings of this study may suggest a potential benefit of integrating MFT into treatment protocols for individuals with lateral elbow pain experiencing Post-needling discomfort. However, further research will be necessary to fully elucidate the clinical implications of these findings and their applicability in healthcare settings.
Universidad Europea de Canarias is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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
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
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
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).
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).
Time frame: 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)
Time frame: 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®.
Time frame: 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.
Time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.
Plan to share: No — Results should not be shared, although they will be available to reviewers upon request.
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Universidad Europea de Canarias