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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569281
• Other study ID #: URJC 08-2015
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 8, 2017
• Start date: October 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
Spain	Cesar Fernandez-de-Las-Peñas	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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