NCT07165379

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-11-01
• Completion: 2027-03-31
• First posted: 2025-09-10
• Last updated: 2025-09-10