Osteo Arthritis KneeNCT07258693
Multimodal Treatment of Knee Osteoarthritis: Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeutic Exercise and Transcutaneous Electrical Nerve Stimulation (TENS) in People Over 60 Years of Age.
A study testing Therapeutic exercise and NESA VS. Therapeutic exercise and TENS in people with Osteo Arthritis Knee, run by University of Jaén at 1 site in Spain.
Trial summary
To analyze the effects of therapeutic exercise combined with noninvasive neuromodulation (NESA) or transcutaneous electrical nerve stimulation (TENS) on improving clinical symptoms such as joint pain and stiffness, as well as its impact on the functionality, mental health, and quality of life of people over 60 years… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Therapeutic exercise and NESA VS. Therapeutic exercise and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2026to 7 Apr 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over 60 years of age.
- Diagnosis of knee osteoarthritis in at least one knee according to the clinical criteria of the American College of Rheumatology.
- Ability to walk independently without the need for assistive devices.
- No medical contraindications to physical exercise or the application of noninvasive neuromodulation (NESA).
- Ability to understand and sign the informed consent form to participate in the study.
Who cannot join
- Present medical contraindications to physical exercise or the application of noninvasive neuromodulation (NSA) (pacemaker, epilepsy, internal bleeding, acute febrile processes, acute thrombophlebitis, and/or phobia of electricity).
- Present active oncological diseases or systemic autoimmune diseases.
- Present severe psychiatric or neurological disorders that limit understanding and collaboration in treatment.
- History of any surgery or fracture of the affected lower limb in the last 3 months.
- Presence of severe gait or balance difficulties that impede the performance of the proposed exercises.
- Simultaneous participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Treatment of Knee Osteoarthritis: Comparison of the Combination of Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeutic Exercise and Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Mental Health in People Over 60 Years of Age.
To analyze the effects of therapeutic exercise combined with noninvasive neuromodulation (NESA) or transcutaneous electrical nerve stimulation (TENS) on improving clinical symptoms such as joint pain and stiffness, as well as its impact on the functionality, mental health, and quality of life of people over 60 years of age with knee osteoarthritis.
Read the detailed description
A single-blind, randomized clinical trial with two intervention groups will be conducted. A pretest-posttest design will be used to evaluate individuals over 60 years of age. Participants will be divided into two groups: one group will receive an 8-week therapeutic exercise program combined with noninvasive neuromodulation (NESA); and the other group will receive the same therapeutic exercise program combined with transcutaneous electrical nerve stimulation (TENS) for 8 weeks. Variables will be measured for both groups using the same validated tools and by the same researchers to avoid information bias and differential misclassification. Assessments will be conducted at the beginning of the intervention and immediately after its completion. The results will be recorded in a database for analysis.
For the independent variables, sociodemographic characteristics will be taken into account. The outcome variables will be divided by domain; pain will be assessed using the Numerical Pain Rating Scale (NPRS), which measures pain intensity. To assess the symptoms and functional capacity associated with knee osteoarthritis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used.
For the physical and functional assessment, the Timed Up and Go Test (TUG) will be used to assess functional mobility, balance, and agility. The Short Physical Performance Battery (SPPB) will be used to evaluate balance, gait, and strength/endurance. Balance and gait will also be assessed using the Tinetti Scale. Knee mobility will be measured with a mobile goniometry/inclinometer in flexion and extension. For strength, a dynamometer will be used to measure isometric strength of major knee movements.
Among the psychosocial factors, catastrophizing will be measured with the PCS (Pain Catastrophizing) and kinesiophobia with the abbreviated version of the TSK-11 (Tampa Scale for Kinesiophobia). Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I).
Quality of life will be measured using the Knee and Hip Osteoarthritis Quality of Life (OAKHQOL) questionnaire. Sleep quality will be measured using the Pittsburgh Index. The Hospital Anxiety and Depression Scale (HADS) will be used for anxiety and depression. Autonomic regulation will be assessed using heart rate variability.
All variables will be measured pre- and post-intervention. As a result, a multimodal treatment is expected to significantly improve clinical symptoms associated with knee osteoarthritis, especially joint pain and stiffness. Additionally, the effectiveness of noninvasive neuromodulation (NESA) will be compared with transcutaneous electrical nerve stimulation (TENS), both in combination with therapeutic exercise. It is also expected to improve functionality, mental health, quality of life, and associated psychosocial factors in people over 60 years of age with knee osteoarthritis. Once the intervention is completed, a final evaluation will be conducted, and the comparative process will determine whether there are significant differences compared to the initial results.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Therapeutic exercise and NESA VS. Therapeutic exercise and TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise and NESA VS. Therapeutic exercise and TENSOther
The study will include two treatment groups over an 8-week intervention. Group 1 will follow a therapeutic exercise program of 24 supervised sessions (three per week, 45-50 minutes each) combined with 24 sessions of non-invasive neuromodulation (NESA). Group 2 will perform the same therapeutic exercise program but combined with 24 sessions of transcutaneous electrical nerve stimulation (TENS), also delivered three times per week for 45 minutes. The exercise program will include strength, power, balance, and proprioception training, with loads individualized according to pain tolerance, physical condition, clinical phase, and symptoms, and progressed gradually by adjusting repetitions, external load, or range of motion. All participants will be assessed before and after the intervention period, with results recorded systematically.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + NESA | Experimental | A treatment group will be enrolled, following an initial assessment and with their consent, in a therapeutic exercise program combined with noninvasive neuromodulation (NESA). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. In addition, 24 noninvasive neuromodulation (NESA) sessions, each lasting 45 minutes, will be delivered three times a week over the course of the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion. Receives: Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS |
| Exercise + TENS | Experimental | A treatment group will receive the same therapeutic exercise program as the experimental group, along with transcutaneous electrical nerve stimulation (TENS). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. Additionally, 24 sessions of transcutaneous electrical nerve stimulation (TENS) will be delivered three times a week, lasting 45 minutes, distributed over the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion. Receives: Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score - Numeric Rating Scale for Pain (0-10)
Pain intensity will be assessed using the Numeric Rating Scale for Pain, which ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. A reduction of ≥2 points is considered clinically significant.
Measured: Up to eight weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Knee osteoarthritis symptoms will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which evaluates pain, stiffness, and physical function. Higher scores indicate worse symptoms.
Measured: Up to eight weeks
Knee Range of Motion - Goniometer
Knee joint range of motion will be evaluated using a goniometer. Lower values indicate reduced mobility, commonly associated with disease severity.
Measured: Up to eight weeks
Strength Tests - Hand-held Dynamometry
Isometric muscle strength of the quadriceps, hamstrings, and handgrip will be measured using a hand-held dynamometer, expressed in kilograms (kg) or newtons (N). Lower scores indicate muscle weakness, often linked to osteoarthritis progression.
Measured: Up to eight weeks
Timed Up and Go (TUG) Performance
Functional mobility will be assessed using the Timed Up and Go test, measured in seconds (standing up, walking 3 m, turning, and sitting down). Values >12 seconds indicate an increased risk of falls.
Measured: Up to eight weeks
Short Physical Performance Battery - Global Score
Physical performance will be assessed through balance tests, gait speed, and sit-to-stand tasks. Scores ≤9 indicate functional limitation.
Measured: Up to eight weeks
Tinetti Balance and Gait Score
Balance and gait will be evaluated using the Tinetti Assessment Tool, ranging from 0 to 28, where scores <19 indicate a high risk of falls.
Measured: Up to eight weeks
Pain Catastrophizing Scale.
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale, ranging from 0 to 52. Scores ≥30 indicate clinically relevant catastrophizing.
Measured: Up to eight weeks
Total TSK-11 Score - Tampa Scale for Kinesiophobia
Kinesiophobia will be measured using the 11-item Tampa Scale for Kinesiophobia, with scores ranging from 11 to 44. Scores ≥23 indicate high fear of movement.
Measured: Up to eight weeks
Falls Efficacy Scale-International
Fear of falling will be assessed using the FES-I, ranging from 16 to 64. Scores >23 indicate concern, and >28 indicate high concern about falling.
Measured: Up to eight weeks
Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which ranges from 0 to 21, with scores >5 indicating poor sleep quality.
Measured: Up to eight weeks
Osteoarthritis Knee and Hip Quality of Life Questionnaire
Quality of life will be evaluated using the Osteoarthritis Knee and Hip Quality of Life Questionnaire, covering physical, mental, and social domains. Higher scores reflect greater impairment.
Measured: Up to eight weeks
Hospital Anxiety and Depression Scale
Anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale, with each subscale ranging from 0 to 21. Scores ≥11 indicate clinically significant symptoms.
Measured: Up to eight weeks
Heart Rate Variability Parameters
Autonomic regulation will be assessed through heart rate variability parameters (SDNN, RMSSD, LF/HF ratio) using ECG or a validated wearable device. Lower HRV indicates poorer autonomic regulation.
Measured: Up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start7 Jan 2026
- Primary completion12 Jan 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258693
- Sponsor's protocol ID
- -UUJA
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Treatment of Knee Osteoarthritis: Comparison of the Combination of Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeutic Exercise and Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Mental Health in People Over 60 Years of Age.
- ClinicalTrials.gov ID
- NCT07258693
- Acronym / sponsor ID
- -UUJA
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 2 Dec 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.
To analyze the effects of therapeutic exercise combined with noninvasive neuromodulation (NESA) or transcutaneous electrical nerve stimulation (TENS) on improving clinical symptoms such as joint pain and stiffness, as well as its impact on the functionality, mental health, and quality of life of people over 60 years of age with knee osteoarthritis.
Detailed description
A single-blind, randomized clinical trial with two intervention groups will be conducted. A pretest-posttest design will be used to evaluate individuals over 60 years of age. Participants will be divided into two groups: one group will receive an 8-week therapeutic exercise program combined with noninvasive neuromodulation (NESA); and the other group will receive the same therapeutic exercise program combined with transcutaneous electrical nerve stimulation (TENS) for 8 weeks. Variables will be measured for both groups using the same validated tools and by the same researchers to avoid information bias and differential misclassification. Assessments will be conducted at the beginning of the intervention and immediately after its completion. The results will be recorded in a database for analysis.
For the independent variables, sociodemographic characteristics will be taken into account. The outcome variables will be divided by domain; pain will be assessed using the Numerical Pain Rating Scale (NPRS), which measures pain intensity. To assess the symptoms and functional capacity associated with knee osteoarthritis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used.
For the physical and functional assessment, the Timed Up and Go Test (TUG) will be used to assess functional mobility, balance, and agility. The Short Physical Performance Battery (SPPB) will be used to evaluate balance, gait, and strength/endurance. Balance and gait will also be assessed using the Tinetti Scale. Knee mobility will be measured with a mobile goniometry/inclinometer in flexion and extension. For strength, a dynamometer will be used to measure isometric strength of major knee movements.
Among the psychosocial factors, catastrophizing will be measured with the PCS (Pain Catastrophizing) and kinesiophobia with the abbreviated version of the TSK-11 (Tampa Scale for Kinesiophobia). Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I).
Quality of life will be measured using the Knee and Hip Osteoarthritis Quality of Life (OAKHQOL) questionnaire. Sleep quality will be measured using the Pittsburgh Index. The Hospital Anxiety and Depression Scale (HADS) will be used for anxiety and depression. Autonomic regulation will be assessed using heart rate variability.
All variables will be measured pre- and post-intervention. As a result, a multimodal treatment is expected to significantly improve clinical symptoms associated with knee osteoarthritis, especially joint pain and stiffness. Additionally, the effectiveness of noninvasive neuromodulation (NESA) will be compared with transcutaneous electrical nerve stimulation (TENS), both in combination with therapeutic exercise. It is also expected to improve functionality, mental health, quality of life, and associated psychosocial factors in people over 60 years of age with knee osteoarthritis. Once the intervention is completed, a final evaluation will be conducted, and the comparative process will determine whether there are significant differences compared to the initial results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + NESA | Experimental | Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENSA treatment group will be enrolled, following an initial assessment and with their consent, in a therapeutic exercise program combined with noninvasive neuromodulation (NESA). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. In addition, 24 noninvasive neuromodulation (NESA) sessions, each lasting 45 minutes, will be delivered three times a week over the course of the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion. |
| Exercise + TENS | Experimental | Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENSA treatment group will receive the same therapeutic exercise program as the experimental group, along with transcutaneous electrical nerve stimulation (TENS). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. Additionally, 24 sessions of transcutaneous electrical nerve stimulation (TENS) will be delivered three times a week, lasting 45 minutes, distributed over the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals over 60 years of age.
- Diagnosis of knee osteoarthritis in at least one knee according to the clinical criteria of the American College of Rheumatology.
- Ability to walk independently without the need for assistive devices.
- No medical contraindications to physical exercise or the application of noninvasive neuromodulation (NESA).
- Ability to understand and sign the informed consent form to participate in the study.
Key exclusion criteria (6 listed)
- Present medical contraindications to physical exercise or the application of noninvasive neuromodulation (NSA) (pacemaker, epilepsy, internal bleeding, acute febrile processes, acute thrombophlebitis, and/or phobia of electricity).
- Present active oncological diseases or systemic autoimmune diseases.
- Present severe psychiatric or neurological disorders that limit understanding and collaboration in treatment.
- History of any surgery or fracture of the affected lower limb in the last 3 months.
- Presence of severe gait or balance difficulties that impede the performance of the proposed exercises.
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 |
|---|---|---|
| Therapeutic exercise and NESA VS. Therapeutic exercise and TENSThe study will include two treatment groups over an 8-week intervention. Group 1 will follow a therapeutic exercise program of 24 supervised sessions (three per week, 45-50 minutes each) combined with 24 sessions of non-invasive neuromodulation (NESA). Group 2 will perform the same therapeutic exercise program but combined with 24 sessions of transcutaneous electrical nerve stimulation (TENS), also delivered three times per week for 45 minutes. The exercise program will include strength, power, balance, and proprioception training, with loads individualized according to pain tolerance, physical condition, clinical phase, and symptoms, and progressed gradually by adjusting repetitions, external load, or range of motion. All participants will be assessed before and after the intervention period, with results recorded systematically. | Other | Exercise + NESA, Exercise + TENS |
Primary outcome
Pain Score - Numeric Rating Scale for Pain (0-10)
Time frame: Up to eight weeks
Pain intensity will be assessed using the Numeric Rating Scale for Pain, which ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. A reduction of ≥2 points is considered clinically significant.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Up to eight weeks
Knee osteoarthritis symptoms will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which evaluates pain, stiffness, and physical function. Higher scores indicate worse symptoms.
Knee Range of Motion - Goniometer
Time frame: Up to eight weeks
Knee joint range of motion will be evaluated using a goniometer. Lower values indicate reduced mobility, commonly associated with disease severity.
Strength Tests - Hand-held Dynamometry
Time frame: Up to eight weeks
Isometric muscle strength of the quadriceps, hamstrings, and handgrip will be measured using a hand-held dynamometer, expressed in kilograms (kg) or newtons (N). Lower scores indicate muscle weakness, often linked to osteoarthritis progression.
Timed Up and Go (TUG) Performance
Time frame: Up to eight weeks
Functional mobility will be assessed using the Timed Up and Go test, measured in seconds (standing up, walking 3 m, turning, and sitting down). Values >12 seconds indicate an increased risk of falls.
Short Physical Performance Battery - Global Score
Time frame: Up to eight weeks
Physical performance will be assessed through balance tests, gait speed, and sit-to-stand tasks. Scores ≤9 indicate functional limitation.
Tinetti Balance and Gait Score
Time frame: Up to eight weeks
Balance and gait will be evaluated using the Tinetti Assessment Tool, ranging from 0 to 28, where scores <19 indicate a high risk of falls.
Pain Catastrophizing Scale.
Time frame: Up to eight weeks
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale, ranging from 0 to 52. Scores ≥30 indicate clinically relevant catastrophizing.
Total TSK-11 Score - Tampa Scale for Kinesiophobia
Time frame: Up to eight weeks
Kinesiophobia will be measured using the 11-item Tampa Scale for Kinesiophobia, with scores ranging from 11 to 44. Scores ≥23 indicate high fear of movement.
Falls Efficacy Scale-International
Time frame: Up to eight weeks
Fear of falling will be assessed using the FES-I, ranging from 16 to 64. Scores >23 indicate concern, and >28 indicate high concern about falling.
Pittsburgh Sleep Quality Index
Time frame: Up to eight weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which ranges from 0 to 21, with scores >5 indicating poor sleep quality.
Osteoarthritis Knee and Hip Quality of Life Questionnaire
Time frame: Up to eight weeks
Quality of life will be evaluated using the Osteoarthritis Knee and Hip Quality of Life Questionnaire, covering physical, mental, and social domains. Higher scores reflect greater impairment.
Hospital Anxiety and Depression Scale
Time frame: Up to eight weeks
Anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale, with each subscale ranging from 0 to 21. Scores ≥11 indicate clinically significant symptoms.
Heart Rate Variability Parameters
Time frame: Up to eight weeks
Autonomic regulation will be assessed through heart rate variability parameters (SDNN, RMSSD, LF/HF ratio) using ECG or a validated wearable device. Lower HRV indicates poorer autonomic regulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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 Therapeutic exercise and NESA VS. Therapeutic exercise and TENS in people with Osteo Arthritis Knee, run by University of Jaén 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 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score - Numeric Rating Scale for Pain (0-10) (time frame: Up to eight weeks). The study lists 14 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 21 Jul 2026.