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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
Mehmet Gürhan KARAKAYA
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    January 17, 2018
    Last Updated
    July 20, 2018
    Sponsor
    Mehmet Gürhan KARAKAYA
    Collaborators
    Muğla Sıtkı Koçman University
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    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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