Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

NCT ID: NCT02793401

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Shoulder Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HILT group

71 of the patients were in the HILT group

Group Type: ACTIVE_COMPARATOR

Hıgh İntensity Laser (HILT)

Intervention Type: DEVICE

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.

Hotpack

Intervention Type: DEVICE

All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

All patients had the same physical therapy (PT) protocol includingTENS (Fizyotens 4000, Fizyomed Medical Devices Ltd,Turkey) (50-100 Hz) for 20 min/session,

Therapeutic exercises

Intervention Type: OTHER

All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles

Balneotherapy

Intervention Type: OTHER

All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.

US Group

70 of the patients were in the US group.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

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.

Hotpack

Intervention Type: DEVICE

All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

All patients had the same physical therapy (PT) protocol includingTENS (Fizyotens 4000, Fizyomed Medical Devices Ltd,Turkey) (50-100 Hz) for 20 min/session,

Therapeutic exercises

Intervention Type: OTHER

All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles

Balneotherapy

Intervention Type: OTHER

All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Hotpack

All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,

Intervention Type: 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,

Intervention Type: DEVICE

Therapeutic exercises

All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles

Intervention Type: OTHER

Balneotherapy

All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.

Intervention Type: OTHER

Other Intervention Names

TENS

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Burcu Metin Ökmen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu Metin Ökmen, MD

Role: STUDY_DIRECTOR

Bursa Yuksek Ihtisas Education and Research Hospital

Korgün Ökmen, MD

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Education and Research Hospital

Kağan Özkuk, MD

Role: STUDY_CHAIR

Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Bilal Uysal, MD

Role: STUDY_CHAIR

Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Refia Sezer, MD

Role: STUDY_CHAIR

Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Engin Koyuncu, MD

Role: STUDY_CHAIR

Ankara Physical Therapy and Rehabilitation Education and Research Hospital

Locations

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BursaYIERH

Identifier Type: -

Identifier Source: org_study_id