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

MUSCULAR STRENGTH

时间窗: Baseline and up to one year

Isometric muscle strength will be assessed using a dynamometer.

LOWER LIMB FUNCTIONAL INDEX (LLFI)

时间窗: 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.

Visual Analogue Scale (VAS)

时间窗: 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.

EUROQOL-5D (EQ-5D)

时间窗: 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)

时间窗: 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)

时间窗: 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.

International Physical Activity Questionnaire (IPAQ)

时间窗: 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).

RANGE OF MOTION

时间窗: 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."