Clinical trial NCT02793401: Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound
Official title: A Comparison of the Efficacy of High Intensity Laser and Ultrasound Therapies in Patients With Chronic Shoulder Pain: A Randomized Controlled Single Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Pain Chronic
Keywords: High Intensity Laser
Ultrasound
Chronic Shoulder Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-06-08
Enrollment: 141
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic shoulder pain, which negatively affects the quality of life due to pain and loss of functions, is the third most common painful condition of the musculoskeletal system\[1\] The aim of the study was to determine more effective conventional physical treatment method (HILT or US) for pain and daily activities of patients with chronic shoulder pain which was difficult to treat, and had unfavorable effects on patient life quality. This prospective, randomized, controlled, single blind study was conducted at the Physical Treatment and Rehabilitation Training and Research Hospital and ethics board approval was obtained.A total of 210 patients, who presented to the hospital with chronic shoulder pain, were evaluated for inclusion in the study. Patients to be included in the study were divided into two groups by the investigating physician, using simple randomization, and their treatment was organized. Forms detailing the patients' (demographics, VAS scores and SPADI) were completed by another investigating physician who was blind to the type of treatment the patients would receive. The same investigating physician completed Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T 30th day) forms and recorded the data. Patients who were randomly divided into two groups received treatment for two weeks (14 days) are shown below:

* Group 1: Hotpack (HP)+ Balneotherapy+ Exercise + HILT
* Group 2: Hotpack (HP)+ Balneotherapy+ Exercise + US

Patients in both groups received HP to the affected shoulder region for 20 minutes and balneotherapy, in mineral water pool at 38-400C for 20 minutes, for seven consecutive days. ROM exercises and Codman exercises, in a level not to increase the severity of the pain of the patient, were given and stretching and strengthening exercises were taught to the patients.The patients performed these exercises daily in two sets with five repeats in each set.

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. 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. Patients were evaluated using VAS and SPADI in pre-treatment (Pre-T), Post-T1st day and Post-T 30th day.

Eligibility criteria: Inclusion Criteria:

* The presence of shoulder pain for more than 3 months patients.

Exclusion Criteria:

* Limitation in the shoulder movements of more than 20%,
* Receiving physical therapy and injection treatment to the same shoulder region in the previous year,
* Malignancy,
* The presence of radicular pain and cervical myofascial pain syndrome,
* A history of acute trauma,
* A prior history of fracture in the shoulder to be treated,
* A prior history of surgical intervention and implantation of a metal implant to the affected shoulder,
* Inflammatory rheumatoid disease.

Primary outcomes:
measure: VAS
timeFrame: Change from Baseline in VAS scores at 15 days and 45 days
measure: SPADI
timeFrame: Change from Baseline in SPADI scores at 15 days and 45 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Yuksek Ihtisas Education and Research Hospital
name: Burcu Metin Ökmen, MD
role: STUDY_DIRECTOR
affiliation: Bursa Yuksek Ihtisas Education and Research Hospital
name: Korgün Ökmen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
name: Kağan Özkuk, MD
role: STUDY_CHAIR
affiliation: Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
name: Bilal Uysal, MD
role: STUDY_CHAIR
affiliation: Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
name: Refia Sezer, MD
role: STUDY_CHAIR
affiliation: Ankara Physical Therapy and Rehabilitation Education and Research Hospital
name: Engin Koyuncu, MD
role: STUDY_CHAIR
References: