Shoulder Pain Chronic Clinical Trial
Official title:
Immediate Effects of Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Stimulation on Subacromial Pain and Shoulder Movements
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 |
Verified date | July 2018 |
Source | Mugla Sitki Koçman University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mehmet Gürhan KARAKAYA | Mugla Sitki Koçman University |
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 |
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