Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

Shoulder Pain Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793401
• Other study ID #: BursaYIERH
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2016
• Last updated: June 3, 2016
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain
• Shoulder Pain Chronic

Intervention

Device:
• High Intensity 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.
• 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.
• Hotpack
All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,
• 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
• Balneotherapy
All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Patients were evaluated using by visual analog scale(VAS) in pre-treatment (Pre-T), 15th day and 45th day. VAS is a frequently used test worldwide, for which reliability and safety studies have been performed.	Change from Baseline in VAS scores at 15 days and 45 days	Yes
Primary	SPADI	Patients were evaluated using SPADI in pre-treatment (Pre-T), 15th day and 45th day. SPADI was developed to measure shoulder discomfort. Its evaluation includes two parts: pain and disability. Part 1 includes five questions in the pain subgroup and measures the pain experienced by the patient over the previous week using VAS (0 no pain, to 10,most severe pain). Part 2 is the disability subgroup and includes eight questions and measures the degree of difficulty (0 no difficulty, to 10, requires help) in the movements of the patient during the last week. SPADI includes 13 questions, and zero point refers to maximal well-being and 130 points refers to maximal sickness.The investigators evaluated each part of the SPADI (shoulder pain index (SPI), shoulder disability index (SDI) and total SPADI) separately.	Change from Baseline in SPADI scores at 15 days and 45 days.	Yes