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

Overview

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.

Interventions

• 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, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds.

Primary outcome measures

• EUROQOL-5D (EQ-5D) [Time frame: Baseline and up to one year]
• SHORT FORM 12 HEALTH SURVEY (SF-12) [Time frame: Baseline and up to one year]
• DISABILITIES OF ARM, SHOULDER AND HAND (DASH) [Time frame: Baseline and up to one year]
• UPPER LIMB FUNCTIONAL INDEX (ULFI) [Time frame: Baseline and up to one year]
• International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline and up to one year]
• Visual Analogue Scale (VAS) [Time frame: Baseline and up to one year]
• RANGE OF MOTION [Time frame: Baseline and up to one year]
• MUSCULAR STRENGTH [Time frame: Baseline and up to one year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07165392 · 152/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗