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

University of Malaga

Status: Not yet enrolling

Conditions: Musculoskeletal Disorders; Lower Limb; Neuromodulation

Treatments: Other: Stretching; Other: Neuromodulation; Other: Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07165379

151/2025

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups

Neuromodulation 2 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Neuromodulation

Other: Stretching

Neuromodulation 3 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Neuromodulation

Other: Stretching

Non-neuromodulation 2 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Stretching

Non-neuromodulation 3 times per week

Experimental group

Treatment:

Other: Physical Exercise

Other: Stretching