Immediate Effects of Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Stimulation on Subacromial Pain and Shoulder Movements
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Primary Endpoint
- Change of pain-free shoulder range of motion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Electrical stimulation with TENS
TENS with 100 Hz frequency, 65 microseconds pulse duration, in continuous pattern
Intervention: Electrical stimulation (Device)
Electrical stimulation with HVPS
HVPS with twin spiked monophasic current at 100 pps frequency, in continuous pattern
Intervention: Electrical stimulation (Device)
Placebo electrical stimulation
same electrode placement with other interventions, using the same electrotherapy device, without activating the device except its time unit.
Intervention: Electrical stimulation (Device)
Outcomes
Primary Outcomes
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
- Change of pain intensity(Change of pain intensity from baseline at the end of 30 minutes of each intervention)
Investigators
Mehmet Gürhan KARAKAYA
Principal investigator, Head of Neurological Rehabilitation Department, PT. PhD. Prof.
Muğla Sıtkı Koçman University