Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

Not Applicable

Completed

• Conditions: Shoulder Pain

• Registration Number: NCT06158568
• Lead Sponsor: César Fernández-de-las-Peñas

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.

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 Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Study Start: 2023-12-01
• Study First Posted: 2023-12-06
• Primary Completion: 2024-01-25
• Status Verified: 2024-04
• Study Completion: 2024-04-27
• Last Update Submitted: 2024-04-27
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in disability between baseline and follow-up periods	Baseline, one week after the last intervention and 1 and 3 months after the intervention	The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

Secondary Outcome Measures

Name	Time	Method
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	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.
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	The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the quality of sleep
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	The Hospital Anxiety and Depression Scale (HADS, A: Anxiety; D: Depression) will be used to evaluate the presence of anxiety/depressive symptoms

Trial Locations

Locations (1)

César Fernández-de-las-Peñas; 🇪🇸 Madrid, Rest Of The World, Spain