Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes in disability before and after the intervention
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
US-guided percutaneous electrolysis
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.
Intervention: US-guided percutaneous electrolysis (Other)
Eccentric exercise
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.
Intervention: Eccentric exercise (Other)
Outcomes
Primary Outcomes
Changes in disability before and after the intervention
Time Frame: Baseline, one week after the last session, 3 months and 6 months after the last session
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Secondary Outcomes
- Changes in functionality before and after the intervention(Baseline, one week after the last session, 3 months and 6 months after the last session)
- Self-perceived improvement(Baseline, one week after the last session, 3 months and 6 months after the last session)
- Changes in pain intensity before and after the intervention(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(Baseline, one week after the last session, 3 months and 6 months after the last session)
Investigators
César Fernández-de-las-Peñas
Head Division
Universidad Rey Juan Carlos