Back to resultsUS-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
US-guided percutaneous electrolysis
Eccentric exercise
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Subacromial pain syndrome, Eccentric exercise, Pressure pain, US-guided percutaneous electrolysis
Eligibility 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
Sites / Locations
- Cesar Fernandez-de-Las-Peñas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
US-guided percutaneous electrolysis
Eccentric exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
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
Full Information
NCT ID
NCT02569281
First Posted
October 2, 2015
Last Updated
October 8, 2017
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02569281
Brief Title
US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
Official Title
Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Subacromial pain syndrome, Eccentric exercise, Pressure pain, US-guided percutaneous electrolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
US-guided percutaneous electrolysis
Arm Type
Experimental
Arm Description
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.
Arm Title
Eccentric exercise
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
US-guided percutaneous electrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Intervention Description
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 Measure Information:
Title
Changes in disability before and after the intervention
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Time Frame
Baseline, one week after the last session, 3 months and 6 months after the last session
Secondary Outcome Measure Information:
Title
Changes in pain intensity before and after the intervention
Description
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.
Time Frame
Baseline, one week after the last session, 3 months and 6 months after the last session
Title
Changes in functionality before and after the intervention
Description
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
Time Frame
Baseline, one week after the last session, 3 months and 6 months after the last session
Title
Changes in pressure pain sensitivity before and after the intervention
Description
Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle
Time Frame
Baseline, one week after the last session, 3 months and 6 months after the last session
Title
Self-perceived improvement
Description
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
Time Frame
Baseline, one week after the last session, 3 months and 6 months after the last session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cesar Fernandez-de-Las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28921
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29777953
Citation
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.
Results Reference
derived
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US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
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