NCT03588143

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

January 17, 2018

Last Update Submit

July 20, 2018

Conditions

Shoulder Pain Chronic

Keywords

Subacromial painJoint range of motionElectrotherapyPhysiotherapyImpingement

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (1)

  • Change of pain intensity

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

Study Arms (3)

Electrical stimulation with TENS

ACTIVE COMPARATOR

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

Device: Electrical stimulation

Electrical stimulation with HVPS

EXPERIMENTAL

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

Device: Electrical stimulation

Placebo electrical stimulation

PLACEBO COMPARATOR

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

Device: Electrical stimulation

Interventions

Electrical stimulationDEVICE

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

Also known as: TENS, HVPS, Placebo
Electrical stimulation with HVPSElectrical stimulation with TENSPlacebo electrical stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Electric StimulationTranscutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesElectric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, Head of Neurological Rehabilitation Department, PT. PhD. Prof.

Study Record Dates

First Submitted

January 17, 2018

First Posted

July 17, 2018

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 24, 2018

Record last verified: 2018-07