Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements

Mehmet Gürhan KARAKAYA

Status: Completed

Conditions: Shoulder Pain Chronic

Treatments: Device: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03588143

16/044

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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106 participants in 3 patient groups, including a placebo group

Electrical stimulation with TENS

Active Comparator group

Description:

TENS with 100 Hz frequency, 65 microseconds pulse duration, in continuous pattern

Treatment:

Device: Electrical stimulation

Electrical stimulation with HVPS

Experimental group

Description:

HVPS with twin spiked monophasic current at 100 pps frequency, in continuous pattern

Treatment:

Device: Electrical stimulation

Placebo electrical stimulation

Placebo Comparator group

Description:

same electrode placement with other interventions, using the same electrotherapy device, without activating the device except its time unit.

Treatment:

Device: Electrical stimulation