Rotator Cuff InjuryNCT06924112
Blood Flow Restriction Exercise-induced Hypoalgesia
A study testing Isometric exercises and Isometric exercises with BFR in people with Rotator Cuff Injury and Rotator Cuff Tear, run by University of Valencia at 1 site in Chile.
Trial summary
The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Injury, Rotator Cuff Tear, Rotator Cuff Repair
- What is being tested?
- Isometric exercises and Isometric exercises with BFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-65 years.
- Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging.
- Undergoing arthroscopic rotator cuff repair
- Be able to read and understand Spanish.
Who cannot join
- Massive irreparable RC tears, concomitant fracture, labral or nerve injury.
- Suspicion of developing/diagnosis a frozen shoulder.
- Revision surgery after RC repair.
- Previous corticosteroid injection (< 1 year).
- Recent surgery (< 1 year) in the contralateral shoulder.
- A history of deep venous thrombosis/pulmonary embolism.
- Peripheral vascular disease, thrombophilia or clotting disorders.
- Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clínica RedSalud Mayor
Temuco, Cautín, 4800580
Daniela Mansilla, MSc, +56996521664, daniela.mansilla@redsalud.cl
Felipe Ponce-Fuentes, MSc
About this study
Official title: Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial
The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH.
Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).
- Conditions
- Rotator Cuff Injury, Rotator Cuff Tear, Rotator Cuff Repair
- Being tested
- Isometric exercises, Isometric exercises with BFR
- Keywords
- blood flow restriction therapy, blood flow restriction training, exercise-induced hypoalgesia
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercisesOther
The three isometric exercises were performed without the addition of BFR following the best evidence recommendations. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the maximal voluntary isometric contraction (MVIC), rest period after each exercise of 2 minutes, and pain level below 5 on the verbal Numeric Pain Rating Scale (NPRS).
Isometric exercises with BFRDevice
Participants will perform three isometric exercises with BFR. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. The session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 60% of the maximum occlusion pressure. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the MVIC, rest period after each exercise of 2 minutes with cuff deflated (reperfusion), and pain level below 5 on the NPRS.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercises with BFR (Intervention A) | Experimental | Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR Receives: Other: Isometric exercises; Device: Isometric exercises with BFR |
| Isometric exercises alone (Intervention B) | Active comparator | Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR Receives: Other: Isometric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT)
Pressure pain threshold will be taken bilaterally on the deltoid muscle and the upper trapezius muscle using a Wagner FPX25 pressure algometer (kg/cm2/sec)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Condicionated pain modulation (CPM)
Condicionated pain modulation will be measured with a conditioning stimulus of inmersion of the hand contralateral to the operated shoulder in cold water (10°C). The bilateral deltoid and trapezius muscles before and after the conditioning stimulus will be measured using a Wagner FPX25 pressure algometer (kg/cm2/sec)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Secondary outcomes (4)
Pain intensity and distribution
Visual Analogue Scale (0 to 10 centimeters) and pain distribution map (number of areas)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Kinesiophobia
Tampa Scale of Kinesiophobia (11 to 44 points)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Self-reported upper extremity disability
Shoulder Pain Disability Index (0 to 100%)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Self-reported quality of life
Western Ontario Rotator Cuff Index (0 to 100%)
Measured: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion29 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuryStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- Felipe Ponce-Fuentes, MSc, Principal investigator, Universidad MayorJose Casaña, PhD, Study director, University of ValenciaJoaquin Calatayud, PhD, Study director, University of ValenciaFilip Struyf, PhD, Study director, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924112
- Sponsor's protocol ID
- P-5.2025
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.
PubMed 32105522Kuppens K, Struyf F, Nijs J, Cras P, Fransen E, Hermans L, Meeus M, Roussel N. Exercise- and Stress-Induced Hypoalgesia in Musicians with and without Shoulder Pain: A Randomized Controlled Crossover Study. Pain Physician. 2016 Feb;19(2):59-68.
PubMed 26815250Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
PubMed 31156448Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Suso-Marti L, Lopez-Bueno R, Nunez-Cortes R, Cruz-Montecinos C, Perez-Alenda S, Casana J, Gargallo P, Calatayud J. Exercise-induced hypoalgesia with end-stage knee osteoarthritis during different blood flow restriction levels: Sham-controlled crossover study. PM R. 2023 Dec;15(12):1565-1573. doi: 10.1002/pmrj.13076. Epub 2023 Dec 8.
PubMed 37796567Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
PubMed 29879638Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.
PubMed 30904519Vaegter HB, Jones MD. Exercise-induced hypoalgesia after acute and regular exercise: experimental and clinical manifestations and possible mechanisms in individuals with and without pain. Pain Rep. 2020 Sep 23;5(5):e823. doi: 10.1097/PR9.0000000000000823. eCollection 2020 Sep-Oct.
PubMed 33062901Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26.
PubMed 32599154Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
PubMed 33471547Ponce-Fuentes F, Cuyul-Vasquez I, Salazar-Mendez J, Lluch E, Suso-Marti L, Cook C, Struyf F, Casana JG, Calatayud J. Exercise-Induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: A Randomized Crossover Clinical Trial. Transl Sports Med. 2026 Apr 16;2026:4698970. doi: 10.1155/tsm2/4698970. eCollection 2026.
PubMed 42005904
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06924112
- Acronym / sponsor ID
- P-5.2025
- Conditions
- Rotator Cuff Injury, Rotator Cuff Tear, Rotator Cuff Repair
- Keywords
- blood flow restriction therapy, blood flow restriction training, exercise-induced hypoalgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Apr 2025 (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 crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH.
Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric exercises with BFR (Intervention A) | Experimental | Other: Isometric exercises, Device: Isometric exercises with BFRParticipants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR |
| Isometric exercises alone (Intervention B) | Active comparator | Other: Isometric exercisesParticipants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40-65 years.
- Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging.
- Undergoing arthroscopic rotator cuff repair
- Be able to read and understand Spanish.
Key exclusion criteria (8 listed)
- Massive irreparable RC tears, concomitant fracture, labral or nerve injury.
- Suspicion of developing/diagnosis a frozen shoulder.
- Revision surgery after RC repair.
- Previous corticosteroid injection (< 1 year).
- Recent surgery (< 1 year) in the contralateral shoulder.
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 |
|---|---|---|
| Isometric exercisesThe three isometric exercises were performed without the addition of BFR following the best evidence recommendations. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the maximal voluntary isometric contraction (MVIC), rest period after each exercise of 2 minutes, and pain level below 5 on the verbal Numeric Pain Rating Scale (NPRS). | Other | Isometric exercises alone (Intervention B), Isometric exercises with BFR (Intervention A) |
| Isometric exercises with BFRParticipants will perform three isometric exercises with BFR. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. The session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 60% of the maximum occlusion pressure. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the MVIC, rest period after each exercise of 2 minutes with cuff deflated (reperfusion), and pain level below 5 on the NPRS. | Device | Isometric exercises with BFR (Intervention A) |
Primary outcome
Pressure pain threshold (PPT)
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Pressure pain threshold will be taken bilaterally on the deltoid muscle and the upper trapezius muscle using a Wagner FPX25 pressure algometer (kg/cm2/sec)
Condicionated pain modulation (CPM)
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Condicionated pain modulation will be measured with a conditioning stimulus of inmersion of the hand contralateral to the operated shoulder in cold water (10°C). The bilateral deltoid and trapezius muscles before and after the conditioning stimulus will be measured using a Wagner FPX25 pressure algometer (kg/cm2/sec)
4 secondary outcomes
Pain intensity and distribution
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Kinesiophobia
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Self-reported upper extremity disability
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Self-reported quality of life
Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 32105522Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.
- Background: PubMed 26815250Kuppens K, Struyf F, Nijs J, Cras P, Fransen E, Hermans L, Meeus M, Roussel N. Exercise- and Stress-Induced Hypoalgesia in Musicians with and without Shoulder Pain: A Randomized Controlled Crossover Study. Pain Physician. 2016 Feb;19(2):59-68.
- Background: PubMed 31156448Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
- Background: PubMed 37796567Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Suso-Marti L, Lopez-Bueno R, Nunez-Cortes R, Cruz-Montecinos C, Perez-Alenda S, Casana J, Gargallo P, Calatayud J. Exercise-induced hypoalgesia with end-stage knee osteoarthritis during different blood flow restriction levels: Sham-controlled crossover study. PM R. 2023 Dec;15(12):1565-1573. doi: 10.1002/pmrj.13076. Epub 2023 Dec 8.
- Background: PubMed 29879638Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
- Background: PubMed 30904519Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.
- Background: PubMed 33062901Vaegter HB, Jones MD. Exercise-induced hypoalgesia after acute and regular exercise: experimental and clinical manifestations and possible mechanisms in individuals with and without pain. Pain Rep. 2020 Sep 23;5(5):e823. doi: 10.1097/PR9.0000000000000823. eCollection 2020 Sep-Oct.
- Background: PubMed 32599154Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26.
- Background: PubMed 33471547Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
- Derived from this study: PubMed 42005904Ponce-Fuentes F, Cuyul-Vasquez I, Salazar-Mendez J, Lluch E, Suso-Marti L, Cook C, Struyf F, Casana JG, Calatayud J. Exercise-Induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: A Randomized Crossover Clinical Trial. Transl Sports Med. 2026 Apr 16;2026:4698970. doi: 10.1155/tsm2/4698970. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Felipe Ponce-Fuentes, MSc principal investigator
Universidad Mayor
Jose Casaña, PhD study director
University of Valencia
Joaquin Calatayud, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercises and Isometric exercises with BFR in people with Rotator Cuff Injury and Rotator Cuff Tear, run by University of Valencia at 1 site in Chile.
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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Casaña, PhD (+34656437371, jose.casana@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) (time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)). 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?
On the ClinicalTrials.gov record for NCT06924112, which also lists 10 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 11 Apr 2025.