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

NCT ID: NCT07165379

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-03-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neuromodulation 2 times per week

Group Type: EXPERIMENTAL

Neuromodulation

Intervention Type: OTHER

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 Exercise

Intervention Type: OTHER

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.

Stretching

Intervention Type: OTHER

To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Neuromodulation 3 times per week

Group Type: EXPERIMENTAL

Neuromodulation

Intervention Type: OTHER

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 Exercise

Intervention Type: OTHER

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.

Stretching

Intervention Type: OTHER

To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Non-neuromodulation 2 times per week

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: OTHER

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.

Stretching

Intervention Type: OTHER

To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Non-neuromodulation 3 times per week

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: OTHER

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.

Stretching

Intervention Type: OTHER

To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Interventions

Neuromodulation

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.

Intervention Type: OTHER

Physical Exercise

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.

Intervention Type: OTHER

Stretching

To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Manuel González-Sánchez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

151/2025

Identifier Type: -

Identifier Source: org_study_id