Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Percutaneous Electrical Nerve Stimulation
* Other: Placebo Percutaneous Electrical Nerve Stimulation
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral non-traumatic shoulder pain Shoulder pain from at least 3 months Shoulder pain of more than 3 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, Percutaneous Nerve Stimulation, Exercise