Lateral Elbow PainPhase 2/3NCT06288048
Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain
A Phase 2/3 study testing Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT and Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching in people with Lateral Elbow Pain, run by Universidad Europea de Canarias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lateral Elbow Pain
- What is being tested?
- Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT and Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 30 Jun 2024
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Europea de Canarias
La Orotava, Santa Cruz De Tenerife, 38300
About this study
Official title: EFECTIVIDAD DE LA TERAPIA EN ESPEJO EN EL DOLOR POSTPUNCIÓN DE PUNTOS GATILLO MIOFASCIALES [EFFECTIVENESS OF MIRROR THERAPY ON POST-PUNCTURE PAIN OF MYOFASCIAL TRIGGER POINTS]
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Lateral Elbow Pain
- Being tested
- Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT, Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching
- Keywords
- Mirror Therapy; Dry Needling; Post-Needling Pain; Myofascial Trigger Point
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFTProcedure or surgery
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 StretchingProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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®.
Measured: 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.
Measured: From before and after the intervention until the conclusion of treatment at the 1-hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2023
- Primary completion7 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Elbow 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Eustaquio Martin Perez, Universidad Europea de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288048
- Sponsor's protocol ID
- 23/107-EC X TFM 07/03/2023
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results should not be shared, although they will be available to reviewers upon request.
Publications
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.
PubMed 30368339
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFECTIVIDAD DE LA TERAPIA EN ESPEJO EN EL DOLOR POSTPUNCIÓN DE PUNTOS GATILLO MIOFASCIALES [EFFECTIVENESS OF MIRROR THERAPY ON POST-PUNCTURE PAIN OF MYOFASCIAL TRIGGER POINTS]
- ClinicalTrials.gov ID
- NCT06288048
- Acronym / sponsor ID
- 23/107-EC X TFM 07/03/2023
- Conditions
- Lateral Elbow Pain
- Keywords
- Mirror Therapy; Dry Needling; Post-Needling Pain; Myofascial Trigger Point
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Universidad Europea de CanariasUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 7 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Mar 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT | Experimental | Procedure: Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFTThe 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. |
| Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching | Active comparator | Procedure: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with StretchingThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFTExperimental: 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 | Procedure or surgery | Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT |
| Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with StretchingThe 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 or surgery | Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching |
Primary outcome
Pain Intensity
Time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.
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).
Pain pressure threshold
Time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.
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)
Two-point discrimination threshold
Time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.
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®.
Maximum hand grip strength
Time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Results publication: PubMed 30368339Martin-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.
- Individual participant dataSharing planned: No. Results should not be shared, although they will be available to reviewers upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT and Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching in people with Lateral Elbow Pain, run by Universidad Europea de Canarias 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Intensity (time frame: From before and after the intervention until the conclusion of treatment at the 1-hour.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288048, which also lists 1 linked publication.
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 1 Mar 2024.