Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06158568
• Other study ID #: URJC0609202218622
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 27, 2024

Study information

• Verified date: April 2024
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 27, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Percutaneous Electrical Nerve Stimulation
Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves
• Placebo Percutaneous Electrical Nerve Stimulation
Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves
• Exercise
Application of three weeks of progressive exercises targeting the shoulder musculature

Locations

Country	Name	City	State
Spain	César Fernández-de-las-Peñas	Madrid	Rest Of The World

Sponsors (1)

Lead Sponsor	Collaborator
César Fernández-de-las-Peñas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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