Knee OsteoarthritisHIPEMF-OAKNCT07198750
"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"
A study testing HI-PEMF - Knee (Chronic Pain Protocol), HI-PEMF - Quadriceps (Muscle Strengthening Protocol) and Home-Based Exercise Program in people with Knee Osteoarthritis and Osteoarthritis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
This randomized, double-blind clinical trial aims to evaluate the effect of high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied either exclusively on the knee joint or bimodally on the knee and quadriceps, in older adults with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis, Osteo Arthritis of the Knee
- What is being tested?
- HI-PEMF - Knee (Chronic Pain Protocol), HI-PEMF - Quadriceps (Muscle Strengthening Protocol) and Home-Based Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2025to 15 Apr 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60
- Clinical and radiological diagnosis of knee OA grade I-IV
- Pain ≥ 3 on Numeric Analog Scale for >6 months
- Can walk (with/without aid)
- Cognitive ability to follow instructions
- Signed informed consent
Show all 23Show fewer
- Availability for 9 treatment sessions and home exercise Exclusion Criteria
- Prior total knee arthroplasty (unilateral or bilateral)
- Neurological disorders affecting motor function or cognition (e.g., Parkinson's disease, stroke, moderate to severe dementia)
- Active inflammatory rheumatic diseases (e.g., rheumatoid arthritis, lupus)
- Presence of pacemakers, implantable defibrillators, or metallic implants near the treatment area
- Current use of other physical therapy modalities for pain (e.g., electrotherapy, ultrasound, TENS) outside the study protocol
- Participation in another clinical trial within the past 3 months
- Current use of NSAIDs or systemic/local corticosteroids (including intra-articular injections)
- Open wounds or active infections at the treatment site
- Decompensated cardiac conditions or medical contraindication to exercise
- Vestibular disorders that affect balance and interfere with functional assessments
- Uncorrected visual impairment interfering with gait or balance (visual acuity worse than 20/60 in the better eye, assessed by Snellen chart)
- Withdrawal Criteria:
- Participants who complete fewer than 7 out of the 9 planned intervention sessions (i.e., less than 80% adherence)
- Occurrence of serious adverse events related to the intervention that contraindicate continuation
- Repeated non-compliance with the home exercise program, documented in at least two consecutive weekly follow-up reports
- Voluntary withdrawal of consent at any time during the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
Ana L Villagrana Rodríguez, MD, +523324261190, alvillagrana@hcg.gob.mx
Ileana Díaz Solís, MD, +523328184251, inforehabilitacion.ids@gmail.com
About this study
Official title: Effect of High-Intensity Pulsed Electromagnetic Field Therapy as a Bimodal Intervention for Analgesia and Strengthening in Older Adults With Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial
This randomized, double-blind clinical trial aims to evaluate the effect of high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied either exclusively on the knee joint or bimodally on the knee and quadriceps, in older adults with knee osteoarthritis. Both groups will also receive a structured home-based exercise program. The primary outcome is pain reduction, and secondary outcomes include functional performance.
Read the detailed description
Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults. It often coexists with quadriceps muscle weakness, sarcopenia, and frailty, all of which contribute to pain, functional decline, and loss of independence. Pulsed electromagnetic field therapy (PEMF) has emerged as a non-invasive alternative for pain relief in OA, with growing interest in its application at both articular and muscular levels.
High-intensity pulsed electromagnetic field (HI-PEMF) therapy-also known as the super inductive system-generates magnetic fields up to 2.5 Tesla, capable of stimulating both joint structures and skeletal muscle via deep tissue electric induction. HI-PEMF has shown promising results for pain reduction, anti-inflammatory modulation, and muscle bioactivation, particularly when applied over the quadriceps.
This randomized, double-blind, parallel-assignment clinical trial aims to compare the effects of two HI-PEMF treatment modalities in older adults with moderate to severe knee OA (Kellgren-Lawrence grade II-IV):
- Group A: HI-PEMF applied exclusively over the symptomatic knee.
- Group 2: HI-PEMF applied both over the knee and the quadriceps (bimodal). Both groups will also perform a standardized home-based strengthening and mobility exercise program.
A total of 64 participants (32 per group) will receive 9 sessions of HI-PEMF (2 per week for 5 weeks), using the BTL-6000 Super Inductive System. Outcomes will be assessed at baseline and post-intervention. The primary outcome is change in pain intensity using the Numeric Analog Scale (NAS). Secondary outcomes include functional tests (Timed Up and Go and 5-times Sit-to-Stand), and paracetamol use. Exploratory subgroup analyses will assess associations with frailty status (FRAIL), probable sarcopenia (SARC-F), and radiological OA grade.
This study seeks to generate evidence on the potential synergistic benefits of combining articular and muscular HI-PEMF therapy in geriatric rehabilitation. It is designed for implementation in a public hospital setting in Mexico, with minimal risk and high feasibility. All procedures follow ethical guidelines and have received institutional review board approval.
- Being tested
- HI-PEMF - Knee (Chronic Pain Protocol), HI-PEMF - Quadriceps (Muscle Strengthening Protocol), Home-Based Exercise Program
- Keywords
- High-Intensity Pulsed Electromagnetic Fields, HI-PEMF, Super Inductive System, Knee Osteoarthritis, Gonarthrosis, Geriatric Rehabilitation, Chronic Pain, Functional Mobility
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HI-PEMF - Knee (Chronic Pain Protocol)Device
High-intensity pulsed electromagnetic field (HI-PEMF) therapy applied to the symptomatic knee using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System, 10-minute duration per session, applied twice per week over 5 weeks (total of 9 sessions). The applicator is positioned 2-3 cm above the patella, without skin contact, with the patient seated or in supine position.
HI-PEMF - Quadriceps (Muscle Strengthening Protocol)Device
HI-PEMF therapy will be applied to both the symptomatic knee and the quadriceps muscle (rectus femoris). The knee application will follow the same procedure as in Group A, using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. In addition, the quadriceps will be treated using the "Muscle Strengthening" protocol. Each site will receive 10 minutes of therapy per session, twice per week over 5 weeks (total of 9 sessions). The applicator for the quadriceps will be positioned perpendicular to the muscle belly, without skin contact, with the patient lying supine and a cushion under the knee for slight flexion.
Home-Based Exercise ProgramBehavioural
Standardized home-based exercise program prescribed to both groups. It includes five exercises: isometric quadriceps contractions, straight leg raises, seated knee extensions, sit-to-stand from chair, and stationary marching. Participants are instructed to perform the exercises three times per week during the 5-week intervention. Printed instructions and a video guide are provided. Adherence is reinforced via weekly follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Unimodal HI-PEMF | Experimental | Participants in Group A will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied exclusively to the symptomatic knee (femorotibial joint) for 10 minutes per session, twice a week over 5 weeks, completing a total of 9 sessions. The intervention will use the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants. Receives: Device: HI-PEMF - Knee (Chronic Pain Protocol); Behavioral: Home-Based Exercise Program |
| Group B - Bimodal HI-PEMF | Experimental | Participants in Group B will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied to both the symptomatic knee (femorotibial joint) and the quadriceps muscle (rectus femoris), with 10 minutes per site, twice a week over 5 weeks, completing a total of 9 sessions. The knee application will follow the "Chronic Pain" protocol, and the quadriceps application will follow the "Muscle Strengthening" protocol, both using the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants. Receives: Device: HI-PEMF - Quadriceps (Muscle Strengthening Protocol); Behavioral: Home-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by the Numeric Analog Scale (NAS)
Pain intensity will be assessed using the 11-point Numeric Analog Scale (0 = no pain, 10 = worst possible pain), reported by the patient at rest and related to the most symptomatic knee. The primary endpoint is the change in NAS score from baseline to end of the 5-week intervention and at 2-month follow-up (approximately week 13). This will allow evaluation of both immediate and sustained effects of the intervention.
Measured: Baseline, end of intervention (week 5), and 2-month follow-up
Secondary outcomes (2)
Change in functional mobility measured by the Timed Up and Go (TUG) test
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants are instructed to stand up from a chair, walk 3 meters, turn around, return, and sit down. The total time (in seconds) will be recorded using a stopwatch. The outcome measure is the change in time from baseline to the end of the 5-week intervention and at 2-month follow-up. This assesses both short-term and sustained improvements in functional mobility.
Measured: Baseline, end of intervention (week 5), and 2-month follow-up
Change in lower-limb functional strength measured by the 5-times Sit-to-Stand (5STS) test
Lower-limb functional strength will be assessed using the 5-times Sit-to-Stand (5STS) test. Participants will be instructed to rise from a standard chair and sit back down five times as quickly as possible without using their arms. The total time (in seconds) to complete the task will be recorded using a stopwatch. The outcome measure is the change in time from baseline to the end of the 5-week intervention and at 2-month follow-up. This evaluates improvements in functional lower-limb strength and endurance over time.
Measured: Baseline, end of intervention (week 5), and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start15 Sep 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- Two-arm parallel design: Group A receives HI-PEMF applied to the knee only (unimodal), while Group B receives HI-PEMF applied to both the knee and quadriceps (bimodal). Both groups also perform the same home-based exercise program.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Lilia Villagrana Rodríguez, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198750
- Sponsor's protocol ID
- CEI-151-25
- Acronym
- HIPEMF-OAK
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because the study is conducted within a public hospital setting without external funding, and there is no current plan or infrastructure to support secondary data sharing. Data will be used exclusively for the primary objectives outlined in the approved protocol.
Publications
Iannitti T, Fistetto G, Esposito A, Rottigni V, Palmieri B. Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly. Clin Interv Aging. 2013;8:1289-93. doi: 10.2147/CIA.S35926. Epub 2013 Sep 26.
PubMed 24106421Ong MT, Man GC, Lau LC, He X, Qiu J, Wang Q, Chow MC, Choi BC, Yu M, Yung PS. Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial. Trials. 2022 Sep 12;23(1):771. doi: 10.1186/s13063-022-06674-2.
PubMed 36096886Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.
PubMed 26705327
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Pulsed Electromagnetic Field Therapy as a Bimodal Intervention for Analgesia and Strengthening in Older Adults With Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07198750
- Acronym / sponsor ID
- HIPEMF-OAK / CEI-151-25
- Keywords
- High-Intensity Pulsed Electromagnetic Fields, HI-PEMF, Super Inductive System, Knee Osteoarthritis, Gonarthrosis, Geriatric Rehabilitation, Chronic Pain, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 30 Sep 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.
This randomized, double-blind clinical trial aims to evaluate the effect of high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied either exclusively on the knee joint or bimodally on the knee and quadriceps, in older adults with knee osteoarthritis. Both groups will also receive a structured home-based exercise program. The primary outcome is pain reduction, and secondary outcomes include functional performance.
Detailed description
Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults. It often coexists with quadriceps muscle weakness, sarcopenia, and frailty, all of which contribute to pain, functional decline, and loss of independence. Pulsed electromagnetic field therapy (PEMF) has emerged as a non-invasive alternative for pain relief in OA, with growing interest in its application at both articular and muscular levels.
High-intensity pulsed electromagnetic field (HI-PEMF) therapy-also known as the super inductive system-generates magnetic fields up to 2.5 Tesla, capable of stimulating both joint structures and skeletal muscle via deep tissue electric induction. HI-PEMF has shown promising results for pain reduction, anti-inflammatory modulation, and muscle bioactivation, particularly when applied over the quadriceps.
This randomized, double-blind, parallel-assignment clinical trial aims to compare the effects of two HI-PEMF treatment modalities in older adults with moderate to severe knee OA (Kellgren-Lawrence grade II-IV):
- Group A: HI-PEMF applied exclusively over the symptomatic knee.
- Group 2: HI-PEMF applied both over the knee and the quadriceps (bimodal). Both groups will also perform a standardized home-based strengthening and mobility exercise program.
A total of 64 participants (32 per group) will receive 9 sessions of HI-PEMF (2 per week for 5 weeks), using the BTL-6000 Super Inductive System. Outcomes will be assessed at baseline and post-intervention. The primary outcome is change in pain intensity using the Numeric Analog Scale (NAS). Secondary outcomes include functional tests (Timed Up and Go and 5-times Sit-to-Stand), and paracetamol use. Exploratory subgroup analyses will assess associations with frailty status (FRAIL), probable sarcopenia (SARC-F), and radiological OA grade.
This study seeks to generate evidence on the potential synergistic benefits of combining articular and muscular HI-PEMF therapy in geriatric rehabilitation. It is designed for implementation in a public hospital setting in Mexico, with minimal risk and high feasibility. All procedures follow ethical guidelines and have received institutional review board approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel design: Group A receives HI-PEMF applied to the knee only (unimodal), while Group B receives HI-PEMF applied to both the knee and quadriceps (bimodal). Both groups also perform the same home-based exercise program.
| Arm | Type | Receives |
|---|---|---|
| Group A - Unimodal HI-PEMF | Experimental | Device: HI-PEMF - Knee (Chronic Pain Protocol), Behavioral: Home-Based Exercise ProgramParticipants in Group A will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied exclusively to the symptomatic knee (femorotibial joint) for 10 minutes per session, twice a week over 5 weeks, completing a total of 9 sessions. The intervention will use the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants. |
| Group B - Bimodal HI-PEMF | Experimental | Device: HI-PEMF - Quadriceps (Muscle Strengthening Protocol), Behavioral: Home-Based Exercise ProgramParticipants in Group B will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied to both the symptomatic knee (femorotibial joint) and the quadriceps muscle (rectus femoris), with 10 minutes per site, twice a week over 5 weeks, completing a total of 9 sessions. The knee application will follow the "Chronic Pain" protocol, and the quadriceps application will follow the "Muscle Strengthening" protocol, both using the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥ 60
- Clinical and radiological diagnosis of knee OA grade I-IV
- Pain ≥ 3 on Numeric Analog Scale for >6 months
- Can walk (with/without aid)
- Cognitive ability to follow instructions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HI-PEMF - Knee (Chronic Pain Protocol)High-intensity pulsed electromagnetic field (HI-PEMF) therapy applied to the symptomatic knee using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System, 10-minute duration per session, applied twice per week over 5 weeks (total of 9 sessions). The applicator is positioned 2-3 cm above the patella, without skin contact, with the patient seated or in supine position. | Device | Group A - Unimodal HI-PEMF |
| HI-PEMF - Quadriceps (Muscle Strengthening Protocol)HI-PEMF therapy will be applied to both the symptomatic knee and the quadriceps muscle (rectus femoris). The knee application will follow the same procedure as in Group A, using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. In addition, the quadriceps will be treated using the "Muscle Strengthening" protocol. Each site will receive 10 minutes of therapy per session, twice per week over 5 weeks (total of 9 sessions). The applicator for the quadriceps will be positioned perpendicular to the muscle belly, without skin contact, with the patient lying supine and a cushion under the knee for slight flexion. | Device | Group B - Bimodal HI-PEMF |
| Home-Based Exercise ProgramStandardized home-based exercise program prescribed to both groups. It includes five exercises: isometric quadriceps contractions, straight leg raises, seated knee extensions, sit-to-stand from chair, and stationary marching. Participants are instructed to perform the exercises three times per week during the 5-week intervention. Printed instructions and a video guide are provided. Adherence is reinforced via weekly follow-up. | Behavioural | Group A - Unimodal HI-PEMF, Group B - Bimodal HI-PEMF |
Primary outcome
Change in pain intensity measured by the Numeric Analog Scale (NAS)
Time frame: Baseline, end of intervention (week 5), and 2-month follow-up
Pain intensity will be assessed using the 11-point Numeric Analog Scale (0 = no pain, 10 = worst possible pain), reported by the patient at rest and related to the most symptomatic knee. The primary endpoint is the change in NAS score from baseline to end of the 5-week intervention and at 2-month follow-up (approximately week 13). This will allow evaluation of both immediate and sustained effects of the intervention.
2 secondary outcomes
Change in functional mobility measured by the Timed Up and Go (TUG) test
Time frame: Baseline, end of intervention (week 5), and 2-month follow-up
Change in lower-limb functional strength measured by the 5-times Sit-to-Stand (5STS) test
Time frame: Baseline, end of intervention (week 5), and 2-month follow-up
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 30 Sep 2025.
- Background: PubMed 24106421Iannitti T, Fistetto G, Esposito A, Rottigni V, Palmieri B. Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly. Clin Interv Aging. 2013;8:1289-93. doi: 10.2147/CIA.S35926. Epub 2013 Sep 26.
- Background: PubMed 36096886Ong MT, Man GC, Lau LC, He X, Qiu J, Wang Q, Chow MC, Choi BC, Yu M, Yung PS. Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial. Trials. 2022 Sep 12;23(1):771. doi: 10.1186/s13063-022-06674-2.
- Background: PubMed 26705327Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because the study is conducted within a public hospital setting without external funding, and there is no current plan or infrastructure to support secondary data sharing. Data will be used exclusively for the primary objectives outlined in the approved protocol.
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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.
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HI-PEMF - Knee (Chronic Pain Protocol), HI-PEMF - Quadriceps (Muscle Strengthening Protocol) and Home-Based Exercise Program in people with Knee Osteoarthritis and Osteoarthritis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 23 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 30 Sep 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 Mexico. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by the Numeric Analog Scale (NAS) (time frame: Baseline, end of intervention (week 5), and 2-month follow-up). 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 NCT07198750, which also lists 3 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 30 Sep 2025.