Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

NCT02793401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2016-06-08

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793401 on ClinicalTrials.gov