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

NCT02569281 | Completed DMC

• 1 other identifier: URJC 08-2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Subacromial pain syndrome; Eccentric exercise; Pressure pain; US-guided percutaneous electrolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 functionality 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

• Self-perceived improvement

  Baseline, one week after the last session, 3 months and 6 months after the last session

Study Arms (2)

US-guided percutaneous electrolysis

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.

Other: US-guided percutaneous electrolysis

Eccentric exercise

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.

Other: Eccentric exercise

Interventions

US-guided percutaneous electrolysis OTHER

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.

US-guided percutaneous electrolysis

Eccentric exercise OTHER

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

Eccentric exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Location

Related Publications (1)

• 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.

  PMID: 29777953 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

ES (1)