US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain

Study Overview
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Brief Summary
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Scientific evidence of conservative management of subacromial pain syndrome is conflicting. There is evidence that eccentric exercise programs are effective at medium term for this pain condition. The inclusion of other therapeutic modalities is still controversial. A recent study suggests that the inclusion of US-guided percutaneous electrolysis combined with eccentric exercises can be effective at short-term for this condition. The objective of this randomized clinical trial is to determine the effectiveness at short- and long-term of the inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol for the management of patients with subacromial pain syndrome for pain, function, disability and pressure pain sensitivity.

Official Title
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Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: US-guided percutaneous electrolysis
* Other: Eccentric exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral shoulder complaints with duration of at least 3 months; an intensity of at least 4 on an 11-point numerical pain rating scale (NPRS) during arm elevation; a positive painful arc test during abduction at least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test Exclusion Criteria: bilateral shoulder symptoms younger than 18 or older than 65 years history of shoulder fractures or dislocation cervical radiculopathy previous interventions with steroid injections fibromyalgia syndrome previous history of shoulder or neck surgery any type of intervention for the neck-shoulder area during the previous year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: US-guided percutaneous electrolysis<br>Patients will receive one weekly session for 5 weeks including best-evidence manual therapy and an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles. The exercise program will be asked to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, they will receive one session of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon. | Other: US-guided percutaneous electrolysis<br>* US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.<br>|
| Active Comparator: Eccentric exercise<br>Patients will receive one weekly session for 5 weeks including best-evidence manual therapy and an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles. The exercise program will be asked to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. | Other: Eccentric exercise<br>* An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in disability before and after the intervention | 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 session, 3 months and 6 months after the last session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain intensity before and after the intervention | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. | Baseline, one week after the last session, 3 months and 6 months after the last session | 
| Changes in functionality before and after the intervention | The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain | Baseline, one week after the last session, 3 months and 6 months after the last session | 
| Changes in pressure pain sensitivity before and after the intervention | Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle | Baseline, one week after the last session, 3 months and 6 months after the last session | 
| Self-perceived improvement | A Global Rating of Change (GROC) from -7 (a very great deal worse) to +7 (a very great deal better) will be used to assess self-perceived improvement | Baseline, one week after the last session, 3 months and 6 months after the last session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacromial pain syndrome, Eccentric exercise, Pressure pain, US-guided percutaneous electrolysis