ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 12 for:    Percutaneous electrolysis

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

October 2, 2015
October 6, 2015
October 10, 2017
October 2015
November 2016   (Final data collection date for primary outcome 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 ]
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Same as current
Complete list of historical versions of study NCT02569281 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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 assesed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle
  • 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
Not Provided
Not Provided
 
US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Shoulder Pain
  • 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.
  • 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
  • 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.
    Intervention: Other: US-guided percutaneous electrolysis
  • 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.
    Intervention: Other: Eccentric exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
September 2017
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT02569281
URJC 08-2015
Yes
Not Provided
Not Provided
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Universidad Rey Juan Carlos
Not Provided
Not Provided
Universidad Rey Juan Carlos
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP