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Completed

NCT Number: NCT06158568

Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

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.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

César Fernández-de-las-Peñas

Madrid, Rest of the World, 28922, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Electrical Nerve Stimulation

Other

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

Placebo Percutaneous Electrical Nerve Stimulation

Other

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

Exercise

Other

Application of three weeks of progressive exercises targeting the shoulder musculature

Primary outcomes

  1. 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

  1. Changes in shoulder pain between baseline and follow-up periods

    Time frame: 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.

  2. Changes in sleep quality between baseline and follow-up periods

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

César Fernández-de-las-Peñas

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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