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NCT Number: NCT07165392

Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Upper Limb: a Double-blind Randomized Clinical Trial

This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the upper 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 brachial plexus nerve root, 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, upper limb function, and a visual analog scale for pain perception.

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Key information

Conditions

Neuromodulation Musculoskeletal Diseases Musculoskeletal Disorders Upper Limb

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in the study will be men and women of working age, diagnosed with musculoskeletal disorders of the upper 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 upper limb due to a pathology of the latter.
  • Medical conditions that are contraindications for neuromodulation therapy

Treatment and study plan

Neuromodulation

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

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

Other

To stretch the muscles involved, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds.

Primary outcomes

  1. EUROQOL-5D (EQ-5D)

    Time frame: 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).

  2. SHORT FORM 12 HEALTH SURVEY (SF-12)

    Time frame: 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.

  3. DISABILITIES OF ARM, SHOULDER AND HAND (DASH)

    Time frame: Baseline and up to one year

    It consists of a self-administered questionnaire that assesses the upper limb as a functional unit and allows for the quantification and comparison of the impact of the different processes affecting different regions of the limb. It consists of a core of 30 items and two optional modules with four items each. Each item is scored from 1 to 5, with higher scores corresponding to greater symptom intensity. The final score can range from 30 to 150 points, with a scale of 0 (best possible score) to 100 (worst possible score). The optional modules are scored separately.

  4. UPPER LIMB FUNCTIONAL INDEX (ULFI)

    Time frame: Baseline and up to one year

    This is a 25-item questionnaire that measures upper limb function. Patients are asked to answer YES if they can perform the action (1 point) and NO if they cannot perform it (0 points). There is also a HALF option (partially 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.

  5. International Physical Activity Questionnaire (IPAQ)

    Time frame: 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).

  6. Visual Analogue Scale (VAS)

    Time frame: 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.

  7. RANGE OF MOTION

    Time frame: Baseline and up to one year

    Range of motion refers to the number of degrees through which a joint is capable of moving. To measure the elbow's flexion-extension range, the flexion and extension movements are recorded with the arms at the sides and the elbows fully extended. For the forearm, supination and pronation movements are measured with the arm relaxed. For the shoulder, the degrees of flexion, extension, abduction, adduction, and internal and external rotation are measured with the patient in a seated position. Finally, to measure flexion, extension, and radial and ulnar deviations at the wrist, the hand is placed on a flat surface. Measurements are taken with an electronic goniometer, and the patient will be asked to cooperate in determining the pain limit.

  8. MUSCULAR STRENGTH

    Time frame: Baseline and up to one year

    Isometric muscle strength will be assessed using a dynamometer.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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