Greater Trocantheric Pain SyndromeNCT06584500
Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol
A study testing Dry needling in people with Greater Trocantheric Pain Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Greater Trocantheric Pain Syndrome
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2024to 8 Nov 2025
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lateral hip pain lasting more than 3 months.
- Greater trochanteric pain syndrome compatible with changes on MRI.
- Clinical examination correlation: one of the following tests must be positive: FADER test, FABER test, hip adduction (ADD) test in side-lying position (DL), isometric contraction test in the ADD position, or single-leg stance test for 30 seconds.
- Pain/sensitization upon palpation of the trochanter.
Who cannot join
- Radicular pain due to lumbar pathology.
- Osteoarthritis.
- Pelvic pathology that could refer pain to the hip.
- Needle phobia.
- Hip injection performed less than 6 months ago.
- Dry needling performed less than 1 month ago.
- Surgery or pathology of the lower limb that prevents single-leg support.
- Systemic diseases that could interfere with the pathological process.
Trial locations and contacts
1 site in 1 country.
María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy contact
Spain1 site
Universidad de Alcalá
Alcalá de Henares, Madrid
Universidad de Alcalá, 91 885 4053 / 4044, secre.gene@uah.es
About this study
Official title: Analysis of the Effect of Dry Needling on the Pelvitrochanteric Musculature on the Potential Contraction of the Gluteus Medius in Patients with Greater Trochanteric Pain Syndrome: Protocol for a Randomized Clinical Trial. Pilot Study
Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.
In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.
This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength…) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.
- Conditions
- Greater Trocantheric Pain Syndrome
- Being tested
- Dry needling, Sham Dry Needling
- Keywords
- greater trochanteric pain syndrome, potential contraction, dry needling, gluteus medius.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Dry needling will be performed on the pelvitrochanteric musculature, targeting those muscles where the patient reports mechanical hyperalgesia points upon palpation that reproduce familiar and recognizable pain. No more than 3 different muscles will be treated, and no more than 2 needles will be used per muscle to reduce irritability. The Gluteus Medius muscle will be needled in all patients, and the Gluteus Minimus, Tensor Fasciae Latae (TFL), Piriformis, and obturator muscles will also be examined.
Dry needling will be performed using monofilament needles of different sizes, 0.30mm x 7.5mm, 6mm, and 4mm (AGUPUNT, APS®), depending on the muscle being treated.\"
During the dry needling procedure, an attempt will be made to provoke a local twitch response (LTR). Once achieved, the needle will be manipulated with rapid in-and-out movements in different directions until 4 to 6 LTRs are obtained, or if the participant verbally requests the intervention to stop.
Sham Dry NeedlingOther
The intervention protocol for sham dry needlig will be just as to the real dry needling procedure, but instead of inserting the needle into the muscle, the needle is manipulated to touch the skin without penetrating it. This may involve the use of retractable needles or simply making contact with the skin
| Study group | Role | What they receive |
|---|---|---|
| E Group | Experimental | Experimental group which receives real dry needling Receives: Other: Dry needling |
| C Group | Sham comparator | Control group which receives sham dry needling Receives: Other: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential Contraction with M-Mode
The primary variable in this study will measure the potential contraction of the gluteus medius. This variable will be assessed using a Sonoscape E2 ultrasound machine with a 5 cm linear probe and the highest scanning speed. The probe will be positioned at the midpoint of the line connecting the anterior and posterior superior iliac spines. In longitudinal scanning, M-mode will be placed cranially to the hip joint capsule. Thickness will be measured from the inner surface of the fascial borders, with the unit of measurement in millimeters (mm). The contraction potential will be the difference between the thickness of the gluteus medius at rest and the thickness at 80% of the maximum voluntary isometric contraction.
Measured: From enrollment to the end of treatment at 4 months
Secondary outcomes (4)
WOMAC hip scale
This is a scale validated in Spanish to measure disability. Barratt et al. recommend the use of condition-specific outcome measures, such as the VISA-G, which is not validated in Spanish. The WOMAC scale has been used to measure disability in patients with Greater Trochanteric Pain Syndrome (GTPS) who speak Spanish.
Measured: From enrollment to the end of treatment at 4 months
Hip Abduction Strength
This will be defined as the amount of force measured by a manual dynamometer during a maximum voluntary isometric contraction. Strength is measured in kilograms (kg) using an Activforce 2 Dynamometer ACTVDIN® model. Participants will lie supine, with the test leg in an anatomical position at 0º hip rotation, and the opposite leg slightly flexed. The dynamometer will be positioned 5 cm proximal to the lateral malleolus, held externally by the examiner, who will stand on the same side as the tested leg. The contraction will be maintained for five seconds, and three measurements will be taken to obtain an average value. If compensatory movements are detected during a measurement, it will not be recorded, and another measurement will be taken.
Measured: From enrollment to the end of treatment at 4 months
Pain
Participants will indicate their pain intensity on a 100 mm horizontal line, with \"no pain\"; at the far left (score 0) and \"worst imaginable pain\"; at the far right (score 10), in relation to the most intense pain episode experienced during daily activities. The Visual Analogue Scale (VAS) has been shown to effectively detect changes in pain, with a minimum clinically significant difference established at 13 mm.
Measured: From enrollment to the end of treatment at 4 months
Passive Hip Range of Motion
It will be measured using an 18 cm plastic universal goniometer (Sammons Preston-Rolyan®). The following movements will be measured: flexion, extension, internal rotation, external rotation, and abduction until the end range without pain. Each movement will be measured three times, and the average value will be used in the analysis.
Measured: From enrollment to the end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion8 Sep 2025 (estimated)
- Study completion8 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Greater Trocantheric Pain SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Suárez del Villar Estéfano, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584500
- Sponsor's protocol ID
- CEIM/2024/4/103
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brennan KL, Allen BC, Maldonado YM. Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Apr;47(4):232-239. doi: 10.2519/jospt.2017.6994. Epub 2017 Mar 3.
PubMed 28257614Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.
PubMed 33567336Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
PubMed 31354339French HP, Woodley SJ, Fearon A, O'Connor L, Grimaldi A. Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice. Physiotherapy. 2020 Dec;109:111-120. doi: 10.1016/j.physio.2019.05.002. Epub 2019 Jun 2.
PubMed 31493863Dieterich AV, Pickard CM, Strauss GR, Deshon LE, Gibson W, McKay J. Muscle thickness measurements to estimate gluteus medius and minimus activity levels. Man Ther. 2014 Oct;19(5):453-60. doi: 10.1016/j.math.2014.04.014. Epub 2014 May 10.
PubMed 24880207Schneider E, Moore ES, Stanborough R, Slaven E. Effects of Trigger Point Dry Needling on Strength Measurements and Activation Levels of the Gluteus Medius: A Quasi-Experimental Randomized Control Study. Int J Sports Phys Ther. 2022 Dec 1;17(7):1404-1416. doi: 10.26603/001c.55536. eCollection 2022.
PubMed 36518833Fearon AM, Scarvell JM, Neeman T, Cook JL, Cormick W, Smith PN. Greater trochanteric pain syndrome: defining the clinical syndrome. Br J Sports Med. 2013 Jul;47(10):649-53. doi: 10.1136/bjsports-2012-091565. Epub 2012 Sep 14.
PubMed 22983121Grimaldi A, Mellor R, Hodges P, Bennell K, Wajswelner H, Vicenzino B. Gluteal Tendinopathy: A Review of Mechanisms, Assessment and Management. Sports Med. 2015 Aug;45(8):1107-19. doi: 10.1007/s40279-015-0336-5.
PubMed 25969366Hilligsoe M, Rathleff MS, Olesen JL. Ultrasound Definitions and Findings in Greater Trochanteric Pain Syndrome: A Systematic Review. Ultrasound Med Biol. 2020 Jul;46(7):1584-1598. doi: 10.1016/j.ultrasmedbio.2020.03.008. Epub 2020 May 5.
PubMed 32381380Plinsinga ML, Ross MH, Coombes BK, Vicenzino B. Physical findings differ between individuals with greater trochanteric pain syndrome and healthy controls: A systematic review with meta-analysis. Musculoskelet Sci Pract. 2019 Oct;43:83-90. doi: 10.1016/j.msksp.2019.07.009. Epub 2019 Jul 25.
PubMed 31369906Segal NA, Felson DT, Torner JC, Zhu Y, Curtis JR, Niu J, Nevitt MC; Multicenter Osteoarthritis Study Group. Greater trochanteric pain syndrome: epidemiology and associated factors. Arch Phys Med Rehabil. 2007 Aug;88(8):988-92. doi: 10.1016/j.apmr.2007.04.014.
PubMed 17678660Lespasio MJ. Lateral Hip Pain: Relation to Greater Trochanteric Pain Syndrome. Perm J. 2022 Jun 29;26(2):83-88. doi: 10.7812/TPP/21.110. Epub 2022 Jun 15.
PubMed 35933677(1) Fredericson M, Lin CY, Chew K. Greater Trochanteric Pain Syndrome. Essentials of Physical Medicine and Rehabilitation 2021 -02-27:346.
Grimaldi A, Mellor R, Nicolson P, Hodges P, Bennell K, Vicenzino B. Utility of clinical tests to diagnose MRI-confirmed gluteal tendinopathy in patients presenting with lateral hip pain. Br J Sports Med. 2017 Mar;51(6):519-524. doi: 10.1136/bjsports-2016-096175. Epub 2016 Sep 15.
PubMed 27633027
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Dry Needling on the Pelvitrochanteric Musculature on the Potential Contraction of the Gluteus Medius in Patients with Greater Trochanteric Pain Syndrome: Protocol for a Randomized Clinical Trial. Pilot Study
- ClinicalTrials.gov ID
- NCT06584500
- Acronym / sponsor ID
- CEIM/2024/4/103
- Conditions
- Greater Trocantheric Pain Syndrome
- Keywords
- greater trochanteric pain syndrome, potential contraction, dry needling, gluteus medius.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 8 Nov 2025 (estimated)
- First posted
- 4 Sep 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.
Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.
In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.
This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength…) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E Group | Experimental | Other: Dry needlingExperimental group which receives real dry needling |
| C Group | Sham comparator | Other: Sham Dry NeedlingControl group which receives sham dry needling |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lateral hip pain lasting more than 3 months.
- Greater trochanteric pain syndrome compatible with changes on MRI.
- Clinical examination correlation: one of the following tests must be positive: FADER test, FABER test, hip adduction (ADD) test in side-lying position (DL), isometric contraction test in the ADD position, or single-leg stance test for 30 seconds.
- Pain/sensitization upon palpation of the trochanter.
Key exclusion criteria (8 listed)
- Radicular pain due to lumbar pathology.
- Osteoarthritis.
- Pelvic pathology that could refer pain to the hip.
- Needle phobia.
- Hip injection performed less than 6 months ago.
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 needlingDry needling will be performed on the pelvitrochanteric musculature, targeting those muscles where the patient reports mechanical hyperalgesia points upon palpation that reproduce familiar and recognizable pain. No more than 3 different muscles will be treated, and no more than 2 needles will be used per muscle to reduce irritability. The Gluteus Medius muscle will be needled in all patients, and the Gluteus Minimus, Tensor Fasciae Latae (TFL), Piriformis, and obturator muscles will also be examined. Dry needling will be performed using monofilament needles of different sizes, 0.30mm x 7.5mm, 6mm, and 4mm (AGUPUNT, APS®), depending on the muscle being treated.\" During the dry needling procedure, an attempt will be made to provoke a local twitch response (LTR). Once achieved, the needle will be manipulated with rapid in-and-out movements in different directions until 4 to 6 LTRs are obtained, or if the participant verbally requests the intervention to stop. | Other | E Group |
| Sham Dry NeedlingThe intervention protocol for sham dry needlig will be just as to the real dry needling procedure, but instead of inserting the needle into the muscle, the needle is manipulated to touch the skin without penetrating it. This may involve the use of retractable needles or simply making contact with the skin | Other | C Group |
Primary outcome
Potential Contraction with M-Mode
Time frame: From enrollment to the end of treatment at 4 months
The primary variable in this study will measure the potential contraction of the gluteus medius. This variable will be assessed using a Sonoscape E2 ultrasound machine with a 5 cm linear probe and the highest scanning speed. The probe will be positioned at the midpoint of the line connecting the anterior and posterior superior iliac spines. In longitudinal scanning, M-mode will be placed cranially to the hip joint capsule. Thickness will be measured from the inner surface of the fascial borders, with the unit of measurement in millimeters (mm). The contraction potential will be the difference between the thickness of the gluteus medius at rest and the thickness at 80% of the maximum voluntary isometric contraction.
4 secondary outcomes
WOMAC hip scale
Time frame: From enrollment to the end of treatment at 4 months
Hip Abduction Strength
Time frame: From enrollment to the end of treatment at 4 months
Pain
Time frame: From enrollment to the end of treatment at 4 months
Passive Hip Range of Motion
Time frame: From enrollment to the end of treatment at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 28257614Brennan KL, Allen BC, Maldonado YM. Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Apr;47(4):232-239. doi: 10.2519/jospt.2017.6994. Epub 2017 Mar 3.
- Background: PubMed 33567336Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.
- Background: PubMed 31354339Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
- Background: PubMed 31493863French HP, Woodley SJ, Fearon A, O'Connor L, Grimaldi A. Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice. Physiotherapy. 2020 Dec;109:111-120. doi: 10.1016/j.physio.2019.05.002. Epub 2019 Jun 2.
- Background: PubMed 24880207Dieterich AV, Pickard CM, Strauss GR, Deshon LE, Gibson W, McKay J. Muscle thickness measurements to estimate gluteus medius and minimus activity levels. Man Ther. 2014 Oct;19(5):453-60. doi: 10.1016/j.math.2014.04.014. Epub 2014 May 10.
- Background: PubMed 36518833Schneider E, Moore ES, Stanborough R, Slaven E. Effects of Trigger Point Dry Needling on Strength Measurements and Activation Levels of the Gluteus Medius: A Quasi-Experimental Randomized Control Study. Int J Sports Phys Ther. 2022 Dec 1;17(7):1404-1416. doi: 10.26603/001c.55536. eCollection 2022.
- Background: PubMed 22983121Fearon AM, Scarvell JM, Neeman T, Cook JL, Cormick W, Smith PN. Greater trochanteric pain syndrome: defining the clinical syndrome. Br J Sports Med. 2013 Jul;47(10):649-53. doi: 10.1136/bjsports-2012-091565. Epub 2012 Sep 14.
- Background: PubMed 25969366Grimaldi A, Mellor R, Hodges P, Bennell K, Wajswelner H, Vicenzino B. Gluteal Tendinopathy: A Review of Mechanisms, Assessment and Management. Sports Med. 2015 Aug;45(8):1107-19. doi: 10.1007/s40279-015-0336-5.
- Background: PubMed 32381380Hilligsoe M, Rathleff MS, Olesen JL. Ultrasound Definitions and Findings in Greater Trochanteric Pain Syndrome: A Systematic Review. Ultrasound Med Biol. 2020 Jul;46(7):1584-1598. doi: 10.1016/j.ultrasmedbio.2020.03.008. Epub 2020 May 5.
- Background: PubMed 31369906Plinsinga ML, Ross MH, Coombes BK, Vicenzino B. Physical findings differ between individuals with greater trochanteric pain syndrome and healthy controls: A systematic review with meta-analysis. Musculoskelet Sci Pract. 2019 Oct;43:83-90. doi: 10.1016/j.msksp.2019.07.009. Epub 2019 Jul 25.
- Background: PubMed 17678660Segal NA, Felson DT, Torner JC, Zhu Y, Curtis JR, Niu J, Nevitt MC; Multicenter Osteoarthritis Study Group. Greater trochanteric pain syndrome: epidemiology and associated factors. Arch Phys Med Rehabil. 2007 Aug;88(8):988-92. doi: 10.1016/j.apmr.2007.04.014.
- Background: PubMed 35933677Lespasio MJ. Lateral Hip Pain: Relation to Greater Trochanteric Pain Syndrome. Perm J. 2022 Jun 29;26(2):83-88. doi: 10.7812/TPP/21.110. Epub 2022 Jun 15.
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.
María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy contact
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 Greater Trocantheric Pain Syndrome, 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 4 inclusion and 8 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 4 Sep 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. Some participants in this study may receive a placebo. 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?
Contact María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy ((+34) 697641648, teresasuarez96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential Contraction with M-Mode (time frame: From enrollment to the end of treatment at 4 months). 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 NCT06584500, which also lists 14 linked publications.
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 4 Sep 2024.