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

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Other: US-guided percutaneous electrolysis; Other: Eccentric exercise

• Registration Number: NCT02569281
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Primary Completion: 2016-11
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-08
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-guided percutaneous electrolysis	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.
Eccentric exercise	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.

Primary Outcome Measures

Name	Time	Method
Changes in disability before and after the intervention	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 Outcome Measures

Name	Time	Method
Changes in functionality before and after the intervention	Baseline, one week after the last session, 3 months and 6 months after the last session	The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
Self-perceived improvement	Baseline, one week after the last session, 3 months and 6 months after the last session	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
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	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.
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	Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle

Trial Locations

Locations (1)

Cesar Fernandez-de-Las-Peñas; 🇪🇸 Alcorcon, Madrid, Spain