NeuromodulationNCT07165379
Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Lower Limb: a Double-blind Randomized Clinical Trial
A study testing Neuromodulation, Physical Exercise and Stretching in people with Neuromodulation and Lower Limb, run by University of Malaga.
Trial summary
This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the lower limb, as well as to determine the difference between two and three sessions per week. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neuromodulation, Lower Limb, Musculoskeletal Disorders
- What is being tested?
- Neuromodulation, Physical Exercise and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Mar 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants in the study will be men and women of working age, diagnosed with musculoskeletal disorders of the lower limb, and who have not yet received physical therapy.
Who cannot join
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients who present muscular atrophy in the lower limb due to a pathology of the latter.
- Medical conditions that are contraindications for neuromodulation therapy
About this study
This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the lower limb, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the nerve root of the lumbosacral plexus, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, lower limb function, and a visual analog scale for pain perception.
- Conditions
- Neuromodulation, Lower Limb, Musculoskeletal Disorders
- Being tested
- Neuromodulation, Physical Exercise, Stretching
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationOther
The application of neuromodulation therapy will be carried out with the support of ultrasound visualization on the anatomical area of the target nerve, seeking a motor and/or sensory response with its stimulation.
Physical ExerciseOther
The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.
StretchingOther
To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation 2 times per week | Experimental | Not described Receives: Other: Neuromodulation; Other: Physical Exercise; Other: Stretching |
| Neuromodulation 3 times per week | Experimental | Not described Receives: Other: Neuromodulation; Other: Physical Exercise; Other: Stretching |
| Non-neuromodulation 2 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching |
| Non-neuromodulation 3 times per week | Experimental | Not described Receives: Other: Physical Exercise; Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
EUROQOL-5D (EQ-5D)
It consists of a generic instrument for measuring health-related quality of life (HRQoL), which consists of two parts: a descriptive system for assessing health status (ranging from 1, meaning "I have no problems" to 3, "many problems") and a visual analogue scale (ranging from 0, which is the worst imaginable health status, to 100, which is the best imaginable health status).
Measured: Baseline and up to one year
SHORT FORM 12 HEALTH SURVEY (SF-12)
The SF-12 questionnaire is composed of a subset of 12 items derived from the SF-36, with the physical and mental components being scored as the only items. Depending on the item, response options range from 3 to 6, with each question receiving a value that is subsequently transformed into a scale of 0 to 100. All scores have a mean of 50, with values above or below 50 indicating better or worse health status, respectively, compared to the reference population.
Measured: Baseline and up to one year
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity) to 4 (no difficulty). The maximum score is 80 (no functional limitations), and the minimum score of 0 indicates extreme limitation. The Spanish adaptation has demonstrated similar values to the English version in the areas of internal consistency, reliability, structure, and error.
Measured: Baseline and up to one year
LOWER LIMB FUNCTIONAL INDEX (LLFI)
This is a 25-item questionnaire that measures lower extremity function. Patients are asked to answer YES if they can perform the action (1 point) and NO if they cannot (0 points). There is also a HALF option (partially able to perform it), which is worth 0.5 points. The score is then obtained by summing the responses and is finally converted into a 100-point percentage scale.
Measured: Baseline and up to one year
International Physical Activity Questionnaire (IPAQ)
An instrument designed to measure physical activity levels in an adult population and serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous activity) to 4 (sedentary).
Measured: Baseline and up to one year
Visual Analogue Scale (VAS)
It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.
Measured: Baseline and up to one year
RANGE OF MOTION
When referring to range of motion, it is understood as the number of degrees through which a joint is capable of moving. To measure the hip, the "Straight Leg Raise Test" (which indirectly measures hamstring extensibility) will be used; hip flexion with the knee flexed (for the gluteus maximus); hip extension using the "Modified Thomas Test" (for the iliopsoas); and hip abduction with the knee extended (for the abductors). At the knee, flexion will be tested with the "Modified Thomas Test," while at the ankle, dorsiflexion will be measured, first with the knee extended using the "Modified Stride Test," and second with the knee flexed using the "Stride Test."
Measured: Baseline and up to one year
MUSCULAR STRENGTH
Isometric muscle strength will be assessed using a dynamometer.
Measured: Baseline and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromodulationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Manuel González-Sánchez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165379
- Sponsor's protocol ID
- 151/2025
- Status last verified
- Jul 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Lower Limb: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07165379
- Acronym / sponsor ID
- 151/2025
- Conditions
- Neuromodulation, Lower Limb, Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 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 project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the lower limb, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the nerve root of the lumbosacral plexus, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, lower limb function, and a visual analog scale for pain perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation 2 times per week | Experimental | Other: Neuromodulation, Other: Physical Exercise, Other: Stretching |
| Neuromodulation 3 times per week | Experimental | Other: Neuromodulation, Other: Physical Exercise, Other: Stretching |
| Non-neuromodulation 2 times per week | Experimental | Other: Physical Exercise, Other: Stretching |
| Non-neuromodulation 3 times per week | Experimental | Other: Physical Exercise, Other: Stretching |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants in the study will be men and women of working age, diagnosed with musculoskeletal disorders of the lower limb, and who have not yet received physical therapy.
Key exclusion criteria (4 listed)
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients who present muscular atrophy in the lower limb due to a pathology of the latter.
- Medical conditions that are contraindications for neuromodulation therapy
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 |
|---|---|---|
| NeuromodulationThe application of neuromodulation therapy will be carried out with the support of ultrasound visualization on the anatomical area of the target nerve, seeking a motor and/or sensory response with its stimulation. | Other | Neuromodulation 2 times per week, Neuromodulation 3 times per week |
| Physical ExerciseThe therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. | Other | Neuromodulation 2 times per week, Neuromodulation 3 times per week, Non-neuromodulation 2 times per week, Non-neuromodulation 3 times per week |
| StretchingTo stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds. | Other | Neuromodulation 2 times per week, Neuromodulation 3 times per week, Non-neuromodulation 2 times per week, Non-neuromodulation 3 times per week |
Primary outcome
EUROQOL-5D (EQ-5D)
Time frame: Baseline and up to one year
It consists of a generic instrument for measuring health-related quality of life (HRQoL), which consists of two parts: a descriptive system for assessing health status (ranging from 1, meaning "I have no problems" to 3, "many problems") and a visual analogue scale (ranging from 0, which is the worst imaginable health status, to 100, which is the best imaginable health status).
SHORT FORM 12 HEALTH SURVEY (SF-12)
Time frame: Baseline and up to one year
The SF-12 questionnaire is composed of a subset of 12 items derived from the SF-36, with the physical and mental components being scored as the only items. Depending on the item, response options range from 3 to 6, with each question receiving a value that is subsequently transformed into a scale of 0 to 100. All scores have a mean of 50, with values above or below 50 indicating better or worse health status, respectively, compared to the reference population.
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
Time frame: Baseline and up to one year
This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity) to 4 (no difficulty). The maximum score is 80 (no functional limitations), and the minimum score of 0 indicates extreme limitation. The Spanish adaptation has demonstrated similar values to the English version in the areas of internal consistency, reliability, structure, and error.
LOWER LIMB FUNCTIONAL INDEX (LLFI)
Time frame: Baseline and up to one year
This is a 25-item questionnaire that measures lower extremity function. Patients are asked to answer YES if they can perform the action (1 point) and NO if they cannot (0 points). There is also a HALF option (partially able to perform it), which is worth 0.5 points. The score is then obtained by summing the responses and is finally converted into a 100-point percentage scale.
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline and up to one year
An instrument designed to measure physical activity levels in an adult population and serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous activity) to 4 (sedentary).
Visual Analogue Scale (VAS)
Time frame: Baseline and up to one year
It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.
RANGE OF MOTION
Time frame: Baseline and up to one year
When referring to range of motion, it is understood as the number of degrees through which a joint is capable of moving. To measure the hip, the "Straight Leg Raise Test" (which indirectly measures hamstring extensibility) will be used; hip flexion with the knee flexed (for the gluteus maximus); hip extension using the "Modified Thomas Test" (for the iliopsoas); and hip abduction with the knee extended (for the abductors). At the knee, flexion will be tested with the "Modified Thomas Test," while at the ankle, dorsiflexion will be measured, first with the knee extended using the "Modified Stride Test," and second with the knee flexed using the "Stride Test."
MUSCULAR STRENGTH
Time frame: Baseline and up to one year
Isometric muscle strength will be assessed using a dynamometer.
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 10 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation, Physical Exercise and Stretching in people with Neuromodulation and Lower Limb, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
EUROQOL-5D (EQ-5D) (time frame: Baseline and up to one year). The study lists 8 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 10 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.