Chronic Instability of JointNCT04108390
Gluteus Medius Dry Needling and Ankle Instability
A study testing Dry needling in people with Chronic Instability of Joint and Trigger Point Pain, Myofascial, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Instability of Joint, Trigger Point Pain, Myofascial
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 25 Mar 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- individuals with chronic ankle instability, 20 to 50 years old.
Who cannot join
- any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability
Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).
Read the detailed description
Inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. Exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.
Initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb.
Once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.
- Being tested
- Dry needling
- Keywords
- ankle, dry needling, trigger point
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Also called Manual Therapy
For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point. Receives: Other: Dry needling |
| Control group | Active comparator | Individuals for this group will be treat with a dry needling technique at 1,5 cm from the trigger point (not in the trigger point). Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Individuals reported the pain intensity with the Visual Analogue Scale (VAS scale). The minimum and maximum scores were 0 (no pain) 100 (the worst pain). There was no sub-scales.
Measured: 1 day
Pain pressure threshold
Pain pressure threshold were recorded with a pressure algometer. Evaluator press the trigger point with the algometer until the patient feel pain. The outcome will be recorder and expressed in kg/cm2
Measured: 1 day
Secondary outcomes (2)
Range of motion
Assess the ankle range of motion with a goniometer.
Measured: 1 day
Balance
Assess the lower limb balance with the star excursion balance test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Jan 2020
- Study completion25 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Instability of JointStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero Morales, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108390
- Sponsor's protocol ID
- CIPI/19/012
- Status last verified
- Jan 2020
- First submitted
- 26 Sep 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04108390
- Acronym / sponsor ID
- CIPI/19/012
- Keywords
- ankle, dry needling, trigger point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 25 Mar 2020 (estimated)
- First posted
- 30 Sep 2019 (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.
Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).
Detailed description
Inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. Exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.
Initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb.
Once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Dry needlingIndividuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point. |
| Control group | Active comparator | Other: Dry needlingIndividuals for this group will be treat with a dry needling technique at 1,5 cm from the trigger point (not in the trigger point). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- individuals with chronic ankle instability, 20 to 50 years old.
Key exclusion criteria (1 listed)
- any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.
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 |
|---|---|---|
| Dry needlingAlso: Manual TherapyFor this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times. | Other | Control group, Intervention group |
Primary outcome
Pain intensity
Time frame: 1 day
Individuals reported the pain intensity with the Visual Analogue Scale (VAS scale). The minimum and maximum scores were 0 (no pain) 100 (the worst pain). There was no sub-scales.
Pain pressure threshold
Time frame: 1 day
Pain pressure threshold were recorded with a pressure algometer. Evaluator press the trigger point with the algometer until the patient feel pain. The outcome will be recorder and expressed in kg/cm2
2 secondary outcomes
Range of motion
Time frame: 1 day
Balance
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Yes
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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 study testing Dry needling in people with Chronic Instability of Joint and Trigger Point Pain, Myofascial, run by Universidad Europea de Madrid 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 1 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 28 Jan 2020. 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?
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: 1 day). The study lists 2 primary outcomes in all. 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 28 Jan 2020.