Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03588143
Other study ID # 16/044
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date January 2017

Study information

Verified date July 2018
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Mehmet Gürhan KARAKAYA Mugla Sitki Koçman University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). Change of pain intensity from baseline at the end of 30 minutes of each intervention
See also
  Status Clinical Trial Phase
Terminated NCT04093700 - MDR SureLock All-Suture Anchor
Completed NCT04190836 - Self-Management for Persistent Subacromial Pain Phase 1
Completed NCT03547570 - Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study N/A
Recruiting NCT05064033 - Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies N/A
Completed NCT02793401 - Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound Phase 4
Completed NCT00567541 - An Implantable Microstimulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects Phase 2
Recruiting NCT05001581 - Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation N/A
Completed NCT03088085 - The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain N/A
Recruiting NCT04124445 - Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain N/A
Withdrawn NCT03797287 - Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair N/A
Completed NCT03869307 - Shoulder Exercises in Hypermobile Patients With Shoulder Symptoms N/A