Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain
- Conditions
- Shoulder Pain
- Interventions
- Other: Percutaneous Electrical Nerve StimulationOther: Placebo Percutaneous Electrical Nerve StimulationOther: Exercise
- Registration Number
- NCT06158568
- Lead Sponsor
- César Fernández-de-las-Peñas
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Percutaneous Electrical Nerve Stimulation Percutaneous Electrical Nerve Stimulation 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 Percutaneous Electrical Nerve Stimulation 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. Placebo Percutaneous Nerve Stimulation Exercise 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. Percutaneous Electrical Nerve Stimulation Exercise 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. Exercise Exercise Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.
- Primary Outcome Measures
Name Time Method Changes in disability between baseline and follow-up periods 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 Outcome Measures
Name Time Method 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 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.
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 The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the quality of sleep
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 The Hospital Anxiety and Depression Scale (HADS, A: Anxiety; D: Depression) will be used to evaluate the presence of anxiety/depressive symptoms
Trial Locations
- Locations (1)
César Fernández-de-las-Peñas
🇪🇸Madrid, Rest Of The World, Spain