Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements
Primary Purpose
Shoulder Pain Chronic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain Chronic focused on measuring Subacromial pain, Joint range of motion, Electrotherapy, Physiotherapy, Impingement
Eligibility Criteria
Inclusion Criteria:
- 18-65 years-old
- Pain with active shoulder movements
- Subacromial pain for 2 weeks-2 months
- Positive Hawkins-Kennedy and painful arc tests, infraspinatus weakness; in addition to these, for patients with partial rotator cuff tear, a negative drop-arm test
- Neer stage 1-2
Exclusion Criteria:
- Radiologically confirmed malignity
- Acromial/acromioclavicular arthritis
- History of fracture or surgery in the affected shoulder-arm complex
- Clinically confirmed polyarthritis, rheumatoid arthritis, fibromyalgia, adhesive capsulitis or osteoarthritis of glenohumeral joint or subacromial region
- Cervical/thoracal spinal problem• Neurological problems which may affect upper extremity movements or pain perception (stroke, peripheral neuropathy, brachial plexus lesion, etc.)
- Neer stage 3 and indication for surgery
- Usage of analgesic medication
- Obesity (Body mass ≥30 kg/m2)
- Contraindications for TENS or HVPS
- Previous experience with electrophysical agents or physiotherapy
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Electrical stimulation with TENS
Electrical stimulation with HVPS
Placebo electrical stimulation
Arm Description
TENS with 100 Hz frequency, 65 microseconds pulse duration, in continuous pattern
HVPS with twin spiked monophasic current at 100 pps frequency, in continuous pattern
same electrode placement with other interventions, using the same electrotherapy device, without activating the device except its time unit.
Outcomes
Primary Outcome Measures
Change of pain-free shoulder range of motion
Pain-free ranges of active shoulder flexion, abduction, internal and external rotation were measured by a digital inclinometer (Baseline Digital Inclinometer, 2008 New York-USA), which was calibrated on a flat surface before each measurement. All evaluations were performed before and after each modality application. All of the measurements were performed by a physiotherapist blinded to the modalities applied (placebo/TENS/HVPS).
Secondary Outcome Measures
Change of pain intensity
The participants were asked to mark their resting pain intensity on a 0-10 cm visual analogue scale (VAS), where 0 cm indicated no pain and 10 cm indicated unbearable pain. The distance of the marked point from zero point was recorded as the intensity of pain. All evaluations were performed before and after each modality application. All of the measurements were performed by a physiotherapist blinded to the modalities applied (placebo/TENS/HVPS).
Full Information
NCT ID
NCT03588143
First Posted
January 17, 2018
Last Updated
July 20, 2018
Sponsor
Mehmet Gürhan KARAKAYA
Collaborators
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT03588143
Brief Title
Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements
Official Title
Immediate Effects of Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Stimulation on Subacromial Pain and Shoulder Movements
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mehmet Gürhan KARAKAYA
Collaborators
Muğla Sıtkı Koçman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was performed to investigate the immediate effects of transcutaneous electrical nerve stimulation (TENS) and high voltage pulsed stimulation (HVPS) on resting pain and pain-free range of shoulder motion (pfROM) in patients with subacromial pain syndrome (SAPS).
Detailed Description
Transcutaneous electrical stimulation (TENS) and high voltage pulsed current/stimulation (HVPS) are both electrotherapeutic agents which can be used for pain relief in musculoskeletal conditions. Standard TENS devices usually deliver biphasic pulsed currents with a pulse duration between 50 μs and 1000 μs and pulse frequencies between 1 and 250 pps. HVPS devices are TENS-like devices which deliver direct current with twin monophasic spiked pulses of 10-500 V (500-ohm load) with a short pulse duration (microseconds). In both conventional TENS technique and HVPS for pain relief, the aim is to activate spinal gating mechanism by selectively stimulating large diameter Aβ fibers. Theoretically, high-frequency (~10-250 pps), low-intensity (nonpainful) currents are most efficient in selectively activating Aβ fibers, which is practically recognized by the user reporting 'strong but comfortable' nonpainful electrical paresthesia beneath the electrodes. There is no available evidence for the efficacy of TENS in patients with subacromial pain. Also, there has been little experimental work on the effects of HVPS on pain relief in the literature, as well as no known study for its efficacy in SAPS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain Chronic
Keywords
Subacromial pain, Joint range of motion, Electrotherapy, Physiotherapy, Impingement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical stimulation with TENS
Arm Type
Active Comparator
Arm Description
TENS with 100 Hz frequency, 65 microseconds pulse duration, in continuous pattern
Arm Title
Electrical stimulation with HVPS
Arm Type
Experimental
Arm Description
HVPS with twin spiked monophasic current at 100 pps frequency, in continuous pattern
Arm Title
Placebo electrical stimulation
Arm Type
Placebo Comparator
Arm Description
same electrode placement with other interventions, using the same electrotherapy device, without activating the device except its time unit.
Intervention Type
Device
Intervention Name(s)
Electrical stimulation
Other Intervention Name(s)
TENS, HVPS, Placebo
Intervention Description
Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention
Primary Outcome Measure Information:
Title
Change of pain-free shoulder range of motion
Description
Pain-free ranges of active shoulder flexion, abduction, internal and external rotation were measured by a digital inclinometer (Baseline Digital Inclinometer, 2008 New York-USA), which was calibrated on a flat surface before each measurement. All evaluations were performed before and after each modality application. All of the measurements were performed by a physiotherapist blinded to the modalities applied (placebo/TENS/HVPS).
Time Frame
Change of pain-free shoulder range of motions from baseline at the end of 30 minutes of each intervention
Secondary Outcome Measure Information:
Title
Change of pain intensity
Description
The participants were asked to mark their resting pain intensity on a 0-10 cm visual analogue scale (VAS), where 0 cm indicated no pain and 10 cm indicated unbearable pain. The distance of the marked point from zero point was recorded as the intensity of pain. All evaluations were performed before and after each modality application. All of the measurements were performed by a physiotherapist blinded to the modalities applied (placebo/TENS/HVPS).
Time Frame
Change of pain intensity from baseline at the end of 30 minutes of each intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years-old
Pain with active shoulder movements
Subacromial pain for 2 weeks-2 months
Positive Hawkins-Kennedy and painful arc tests, infraspinatus weakness; in addition to these, for patients with partial rotator cuff tear, a negative drop-arm test
Neer stage 1-2
Exclusion Criteria:
Radiologically confirmed malignity
Acromial/acromioclavicular arthritis
History of fracture or surgery in the affected shoulder-arm complex
Clinically confirmed polyarthritis, rheumatoid arthritis, fibromyalgia, adhesive capsulitis or osteoarthritis of glenohumeral joint or subacromial region
Cervical/thoracal spinal problem• Neurological problems which may affect upper extremity movements or pain perception (stroke, peripheral neuropathy, brachial plexus lesion, etc.)
Neer stage 3 and indication for surgery
Usage of analgesic medication
Obesity (Body mass ≥30 kg/m2)
Contraindications for TENS or HVPS
Previous experience with electrophysical agents or physiotherapy
Pregnancy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements
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