Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

NCT06158568 | Completed DMC

• 1 other identifier: URJC0609202218622
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.

Conditions

Shoulder Pain

Keywords

Neuromodulation; Percutaneous Nerve Stimulation; Exercise

Outcome Measures

Primary Outcomes (1)

• Changes in disability between baseline and follow-up periods

  The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

  Baseline, one week after the last intervention and 1 and 3 months after the intervention

Secondary Outcomes (3)

• Changes in shoulder pain between baseline and follow-up periods

  Baseline, one week after the last intervention and 1 and 3 months after the intervention

• Changes in sleep quality between baseline and follow-up periods

  Baseline, one week after the last intervention and 1 and 3 months after the intervention

• Changes in anxiety/depressive symptoms between baseline and follow-up periods

  Baseline, one week after the last intervention and 1 and 3 months after the intervention

Study Arms (3)

Percutaneous Electrical Nerve Stimulation

EXPERIMENTAL

Participants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks.

Other: Percutaneous Electrical Nerve Stimulation; Other: Exercise

Placebo Percutaneous Nerve Stimulation

PLACEBO COMPARATOR

Participants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks.

Other: Placebo Percutaneous Electrical Nerve Stimulation; Other: Exercise

Exercise

ACTIVE COMPARATOR

Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.

Other: Exercise

Interventions

Percutaneous Electrical Nerve Stimulation OTHER

Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves

Percutaneous Electrical Nerve Stimulation

Placebo Percutaneous Electrical Nerve Stimulation OTHER

Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves

Placebo Percutaneous Nerve Stimulation

Exercise OTHER

Application of three weeks of progressive exercises targeting the shoulder musculature

Exercise; Percutaneous Electrical Nerve Stimulation; Placebo Percutaneous Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)
• Shoulder pain from at least 3 months
• Shoulder pain of more than 3/10 points on a NPRS

You may not qualify if:

• Bilateral shoulder symptoms
• Younger than 18 or older than 65 years
• History of shoulder traumatisms, fractures or dislocation
• Diagnosis of cervical radiculopathy or myelopathy
• Previous interventions with steroid injections in the shoulder area
• Comorbid medical conditions, e.g., fibromyalgia syndrome
• Previous history of shoulder or neck surgery
• Any type of intervention for the neck-shoulder area during the previous year
• Fear to needles

Sponsors & Collaborators

• César Fernández-de-las-Peñas: lead

Study Sites (1)

César Fernández-de-las-Peñas

Madrid, Rest of the World, 28922, Spain

Location

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

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 Officials

• César Fernández-de-las-Peñas, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2023
• Primary Completion: January 25, 2024
• Study Completion: April 27, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

ES (1)