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

NCT ID: NCT03588143

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-01-31

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.

Conditions

Shoulder Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Electrical stimulation with TENS

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

Group Type: ACTIVE_COMPARATOR

Electrical stimulation

Intervention Type: DEVICE

Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention

Electrical stimulation with HVPS

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

Group Type: EXPERIMENTAL

Electrical stimulation

Intervention Type: DEVICE

Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention

Placebo electrical stimulation

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

Group Type: PLACEBO_COMPARATOR

Electrical stimulation

Intervention Type: DEVICE

Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention

Interventions

Electrical stimulation

Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention

Intervention Type: DEVICE

Other Intervention Names

TENS; HVPS; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: collaborator

Mehmet Gürhan KARAKAYA

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Gürhan KARAKAYA

Principal investigator, Head of Neurological Rehabilitation Department, PT. PhD. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

16/044

Identifier Type: -

Identifier Source: org_study_id