Clinical trial NCT03588143: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain Chronic
Keywords: Subacromial pain
Joint range of motion
Electrotherapy
Physiotherapy
Impingement
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
First posted: 2018-07-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of pain-free shoulder range of motion
timeFrame: Change of pain-free shoulder range of motions from baseline at the end of 30 minutes of each intervention
Secondary outcomes:
measure: Change of pain intensity
timeFrame: Change of pain intensity from baseline at the end of 30 minutes of each intervention
Other outcomes:
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