Ankle SprainsNCT05680779
Neuromodulation in Chronic Ankle Instability
A study testing ultrasound-guided percutaneous neuromodulation and dry needling in people with Ankle Sprains, run by University of Alcala at 1 site in Spain.
Trial summary
Ankle sprain is a common injury. Around 712,000 sprains occur every day in the world. It is estimated that they account for 45% of sports injuries, being the second part of the body that is most frequently injured in sports. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- ultrasound-guided percutaneous neuromodulation and dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jul 2023to 2 May 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle instability
Who cannot join
- Subjects taking NSAIDs, analgesics or muscle relaxants
- Epilepsy
- Belonephobia or allergy to metals
Trial locations and contacts
1 site in 1 country.
Spain1 site
Physioterapy and Pain center research
Alcalá de Henares, Madrid, 28805
About this study
Official title: Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability
Ankle sprain is a common injury. Around 712,000 sprains occur every day in the world. It is estimated that they account for 45% of sports injuries, being the second part of the body that is most frequently injured in sports. Of the patients who suffer this injury, around 70% will develop chronic ankle instability, a situation that can cause residual pain, recurrent sprains, a feeling of lack of stability and decreased physical activity.
Two entities can be included in chronic ankle instability: mechanical instability, which involves movement of the joint beyond its physiological limit, and functional instability, which includes proprioceptive dysfunction, impaired neuromuscular control, postural control, and strength deficits.
Read more
Currently, the conservative treatment of these patients consists of neuromuscular training through the use of dynamic balance platforms, taping, joint mobilization, dry needling, and the use of plantar supports, balance training being the one that has shown the best result.
Ultrasound-guided percutaneous neuromodulation (PNM) is a recently used technique in the field of invasive physiotherapy that consists of applying a square wave biphasic electrical current through an acupuncture needle-like electrode that is place in close proximity to the nerve with ultrasound guidance. The aim of this study is to evaluate the effectiveness of PNM in ankle instability.
- Conditions
- Ankle Sprains
- Being tested
- ultrasound-guided percutaneous neuromodulation, dry needling
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided percutaneous neuromodulationOther
It´s an intervention of physiotherapy
dry needlingOther
It´s an intervention of physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| PNM group | Experimental | Subjects were treated once time. The technique consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, with 250 μs pulse width and the maximal torelable intensity to cause an exacerbated muscle contraction during ten seconds with a rest period of another ten seconds y total number of ten times. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity) Receives: Other: ultrasound-guided percutaneous neuromodulation |
| Control group | Other | Subjects were treated once time. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity). The needle remains in this location during 200 seconds without any electrical current. Receives: Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumberland ankle instability tool
The Cumberland ankle instability tool (CAIT) is a questionnaire that consists of 9 items, the maximum score of the questionnaire is 30 points, the lower the score obtained, the more severe the functional instability of the ankle. The Spanish version of the CAIT has high internal consistency (Cronbach's α00.766) and reliability (intraclass correlation coefficient 0.979, 95 % confidence interval (CI) 0.958-0.990).
Measured: Change from Baseline up to three months
Secondary outcomes (3)
Byodex Balance System (BBS)
The BBS is a platform designed to measure and record an individual´s ability to maintain stability under dynamic stress. It calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI) with reliability estimates of R= 0.92 (OSI), R = 0.89 (APSI), R= 0.93 (MLSI).
Measured: Change from Baseline up to 5 minutes
Electromyography muscle (EMG)
Mdurance EMG system is valid tool to measure muscle activity during isokinetic contractions. It has shown an almost perfect Intraclass Correlation Coefficient>0.81.
Measured: Change from Baseline up to 5 minutes
stiffness tissue
Myoton Pro is a device designed to measure and record Oscillation frequency (pitch), dynamic stiffness (stiffness), logarithmic decrement (elasticity), mechanical stress relaxation time and creep. It has shown an excellent reliability, Intraclass Correlation Coefficient 0.91-0.96 in all measures with the exception of elasticity 0.78-0.86
Measured: Change from Baseline up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start23 Jul 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680779
- Sponsor's protocol ID
- CEID/2022/2/031
- Status last verified
- May 2024
- First submitted
- 23 Dec 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05680779
- Acronym / sponsor ID
- CEID/2022/2/031
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 11 Jan 2023 (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.
Ankle sprain is a common injury. Around 712,000 sprains occur every day in the world. It is estimated that they account for 45% of sports injuries, being the second part of the body that is most frequently injured in sports. Of the patients who suffer this injury, around 70% will develop chronic ankle instability, a situation that can cause residual pain, recurrent sprains, a feeling of lack of stability and decreased physical activity.
Two entities can be included in chronic ankle instability: mechanical instability, which involves movement of the joint beyond its physiological limit, and functional instability, which includes proprioceptive dysfunction, impaired neuromuscular control, postural control, and strength deficits.
Currently, the conservative treatment of these patients consists of neuromuscular training through the use of dynamic balance platforms, taping, joint mobilization, dry needling, and the use of plantar supports, balance training being the one that has shown the best result.
Ultrasound-guided percutaneous neuromodulation (PNM) is a recently used technique in the field of invasive physiotherapy that consists of applying a square wave biphasic electrical current through an acupuncture needle-like electrode that is place in close proximity to the nerve with ultrasound guidance. The aim of this study is to evaluate the effectiveness of PNM in ankle instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNM group | Experimental | Other: ultrasound-guided percutaneous neuromodulationSubjects were treated once time. The technique consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, with 250 μs pulse width and the maximal torelable intensity to cause an exacerbated muscle contraction during ten seconds with a rest period of another ten seconds y total number of ten times. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity) |
| Control group | Other | Other: dry needlingSubjects were treated once time. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity). The needle remains in this location during 200 seconds without any electrical current. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ankle instability
Key exclusion criteria (3 listed)
- Subjects taking NSAIDs, analgesics or muscle relaxants
- Epilepsy
- Belonephobia or allergy to metals
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 |
|---|---|---|
| ultrasound-guided percutaneous neuromodulationIt´s an intervention of physiotherapy | Other | PNM group |
| dry needlingIt´s an intervention of physiotherapy | Other | Control group |
Primary outcome
Cumberland ankle instability tool
Time frame: Change from Baseline up to three months
The Cumberland ankle instability tool (CAIT) is a questionnaire that consists of 9 items, the maximum score of the questionnaire is 30 points, the lower the score obtained, the more severe the functional instability of the ankle. The Spanish version of the CAIT has high internal consistency (Cronbach's α00.766) and reliability (intraclass correlation coefficient 0.979, 95 % confidence interval (CI) 0.958-0.990).
3 secondary outcomes
Byodex Balance System (BBS)
Time frame: Change from Baseline up to 5 minutes
Electromyography muscle (EMG)
Time frame: Change from Baseline up to 5 minutes
stiffness tissue
Time frame: Change from Baseline up to 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
Daniel Pecos-Martin, PhD study chair
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided percutaneous neuromodulation and dry needling in people with Ankle Sprains, run by University of Alcala 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 3 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumberland ankle instability tool (time frame: Change from Baseline up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.