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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Malaga

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Neuromodulation

    Other intervention

    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

    Other intervention

    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

    Other intervention

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

Treatment groups

64 Participants
are divided into 4 treatment groups
Group A: Neuromodulation 2 times per weekExperimental treatment 3 interventions
Group B: Neuromodulation 3 times per weekExperimental treatment 3 interventions
Group C: Non-neuromodulation 2 times per weekExperimental treatment 2 interventions
Group D: Non-neuromodulation 3 times per weekExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and up to one year
2

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.

Time frame
Baseline and up to one year
3

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.

Time frame
Baseline and up to one year
4

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.

Time frame
Baseline and up to one year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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