Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound
NCT02793401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2016-06-08
Summary
The investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy (HILT) and Ultrasound (US) treatment in chronic shoulder pain. It's a prospective, randomized, controlled, single blind study.141 patients were randomized into two groups, as HILT (n=71) and US (n=70) groups. HILT or US treatment was applied to the patients in addition to 14 sessions of Hotpack (Hp) + Balneotherapy + Exercise treatment. Pre-treatment (Pre-T), Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T 30th day) were recorded using the visual analog scale (VAS) and shoulder pain and disability index (SPADI) scoring.
Conditions
- Shoulder Pain Chronic
Interventions
- DEVICE
-
Hıgh İntensity Laser (HILT)
HILT was performed using a BTL-6000 High Intensity Laser, 12 W(watt), 1064 nm device was a hot laser with Nd: YAG LASER source. In HILT group, the investigators applied the device on the shoulder area in two phases: phase I - analgesia, and phase II - biostimulation.
- DEVICE
-
Ultrasound
BTL 4710 US device was applied at 3 MHz frequency, and 1.5watt/cm2 intensity over 25 cm2 surface area. Headpiece area of the device was 5 cm2, and the application was performed as the head of device was positioned at 90º (perpendicular) at full contact for 5 minutes by using gel, and performing continuous circular motions.
- DEVICE
-
Hotpack
All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,
- DEVICE
-
Transcutaneous electrical nerve stimulation
All patients had the same physical therapy (PT) protocol includingTENS (Fizyotens 4000, Fizyomed Medical Devices Ltd,Turkey) (50-100 Hz) for 20 min/session,
- OTHER
-
Therapeutic exercises
All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles
- OTHER
-
Balneotherapy
All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.
Sponsors & Collaborators
-
Bursa Yuksek Ihtisas Training and Research Hospital
lead OTHER_GOV
Principal Investigators
-
Burcu Metin Ökmen, MD · Bursa Yuksek Ihtisas Education and Research Hospital
-
Korgün Ökmen, MD · Bursa Yuksek Ihtisas Education and Research Hospital
-
Kağan Özkuk, MD · Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
-
Bilal Uysal, MD · Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
-
Refia Sezer, MD · Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
-
Engin Koyuncu, MD · Ankara Physical Therapy and Rehabilitation Education and Research Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-09-30
Countries
- Turkey (Türkiye)
Study Locations
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