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Clinical Trials/NCT06158568
NCT06158568CompletedNot Applicable

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

César Fernández-de-las-Peñas2 sites in 1 country59 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
59
Locations
2
Primary Endpoint
Changes in disability between baseline and follow-up periods

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Changes in disability between baseline and follow-up periods

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
César Fernández-de-las-Peñas
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

César Fernández-de-las-Peñas

Clinical Professor

Universidad Rey Juan Carlos

Study Sites (2)

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