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

NCT07165392 | Not Yet Recruiting

• 1 other identifier: 152/2025
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuromodulation; Upper Limb; Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (8)

• 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).

  Baseline and up to one year

• 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.

  Baseline and up to one year

• DISABILITIES OF ARM, SHOULDER AND HAND (DASH)

  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.

  Baseline and up to one year

• UPPER LIMB FUNCTIONAL INDEX (ULFI)

  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.

  Baseline and up to one year

• International Physical Activity Questionnaire (IPAQ)

  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).

  Baseline and up to one year

• Visual Analogue Scale (VAS)

  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.

  Baseline and up to one year

• RANGE OF MOTION

  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.

  Baseline and up to one year

• MUSCULAR STRENGTH

  Isometric muscle strength will be assessed using a dynamometer.

  Baseline and up to one year

Study Arms (4)

Neuromodulation 2 times per week

EXPERIMENTAL

Other: Neuromodulation; Other: Physical Exercise; Other: Stretching

Neuromodulation 3 times per week

EXPERIMENTAL

Other: Neuromodulation; Other: Physical Exercise; Other: Stretching

Non-neuromodulation 2 times per week

EXPERIMENTAL

Other: Physical Exercise; Other: Stretching

Non-neuromodulation 3 times per week

EXPERIMENTAL

Other: Physical Exercise; Other: Stretching

Interventions

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.

Neuromodulation 2 times per week; Neuromodulation 3 times per week

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.

Neuromodulation 2 times per week; Neuromodulation 3 times per week; Non-neuromodulation 2 times per week; Non-neuromodulation 3 times per week

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.

Neuromodulation 2 times per week; Neuromodulation 3 times per week; Non-neuromodulation 2 times per week; Non-neuromodulation 3 times per week

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-07