Clinical trial NCT02569281: US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
Official title: Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Subacromial pain syndrome
Eccentric exercise
Pressure pain
US-guided percutaneous electrolysis
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in disability before and after the intervention
timeFrame: Baseline, one week after the last session, 3 months and 6 months after the last session
Secondary outcomes:
measure: Changes in pain intensity before and after the intervention
timeFrame: Baseline, one week after the last session, 3 months and 6 months after the last session
measure: Changes in functionality before and after the intervention
timeFrame: Baseline, one week after the last session, 3 months and 6 months after the last session
measure: Changes in pressure pain sensitivity before and after the intervention
timeFrame: Baseline, one week after the last session, 3 months and 6 months after the last session
measure: Self-perceived improvement
timeFrame: Baseline, one week after the last session, 3 months and 6 months after the last session
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Cesar Fernandez-de-Las-Peñas
state: Madrid
Study officials:
References:
citation: de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16.