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OpenTrials
Completed

NCT Number: NCT03588143

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

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).

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Key information

Conditions

Shoulder Pain Chronic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Stimulation

Device

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

Other names: TENS, HVPS, Placebo

Primary outcomes

  1. Change of pain-free shoulder range of motion

    Time frame: Change of pain-free shoulder range of motions from baseline at the end of 30 minutes of each intervention

    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 outcomes

  1. Change of pain intensity

    Time frame: Change of pain intensity from baseline at the end of 30 minutes of each intervention

    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).

Sponsors and collaborators

Lead sponsor

Mehmet Gürhan KARAKAYA

Other

Collaborators

  • Muğla Sıtkı Koçman University

Registry information

Official study title

Immediate Effects of Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Stimulation on Subacromial Pain and Shoulder Movements

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2018
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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