Overview

This trial is active, not recruiting.

Condition shoulder pain
Treatments us-guided percutaneous electrolysis, eccentric exercise
Sponsor Universidad Rey Juan Carlos
Start date October 2015
End date May 2016
Trial size 50 participants
Trial identifier NCT02569281, URJC 08-2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
us-guided percutaneous electrolysis
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.
(Active Comparator)
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.
eccentric exercise
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Changes in pain intensity before and after the intervention
time frame: Baseline, one week after the last session, 3 months and 6 months after the last session
Changes in functionality before and after the intervention
time frame: 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
time frame: Baseline, one week after the last session, 3 months and 6 months after the last session
Self-perceived improvement
time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Universidad Rey Juan Carlos.