Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

Effects of Percutaneous Electrical Nerve Stimulation and Exercise for Patients With Subacromial Pain Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Percutaneous Electrical Nerve Stimulation; Other: Exercise; Other: Placebo Percutaneous Electrical Nerve Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Rest Of The World
    • Madrid, Rest Of The World, Spain, 28922
      • César Fernández-de-las-Peñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Electrical Nerve Stimulation; 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; Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves; Other: Exercise; Application of three weeks of progressive exercises targeting the shoulder musculature
Placebo Comparator: Placebo Percutaneous Nerve Stimulation; 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: Exercise; Application of three weeks of progressive exercises targeting the shoulder musculature; Other: Placebo Percutaneous Electrical Nerve Stimulation; Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves
Active Comparator: Exercise; Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.	Other: Exercise; Application of three weeks of progressive exercises targeting the shoulder musculature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in shoulder pain between baseline and follow-up periods	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' mean level of shoulder pain experienced in the preceding week in the shoulder area.	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	The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the quality of sleep	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	The Hospital Anxiety and Depression Scale (HADS, A: Anxiety; D: Depression) will be used to evaluate the presence of anxiety/depressive symptoms	Baseline, one week after the last intervention and 1 and 3 months after the intervention

Collaborators and Investigators

• Sponsor: César Fernández-de-las-Peñas
• Investigators: Principal Investigator: César Fernández-de-las-Peñas, PhD, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): April 27, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Neuromodulation; Percutaneous Nerve Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: URJC0609202218622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No