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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569281
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, 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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: US-guided percutaneous electrolysis Other: Eccentric exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Other: 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 Outcome Measures :
  1. 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 ]
    The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain

  3. 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 ]
    Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle

  4. Self-perceived improvement [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569281


Locations
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Spain
Cesar Fernandez-de-Las-Peñas
Alcorcon, Madrid, Spain, 28921
Sponsors and Collaborators
Universidad Rey Juan Carlos
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: César Fernández-de-las-Peñas, Head Division, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02569281    
Other Study ID Numbers: URJC 08-2015
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Keywords provided by César Fernández-de-las-Peñas, Universidad Rey Juan Carlos:
Subacromial pain syndrome
Eccentric exercise
Pressure pain
US-guided percutaneous electrolysis
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations