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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Electrical Nerve Stimulation | Experimental | 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. |
|
| Placebo Percutaneous Nerve Stimulation | Placebo Comparator | 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. |
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| Exercise | Active Comparator | Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Electrical Nerve Stimulation | Other | Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| César Fernández-de-las-Peñas, PhD | Universidad Rey Juan Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| César Fernández-de-las-Peñas | Madrid | Rest of the World | 28922 | Spain |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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 |
|
| 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |