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Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

Primary Purpose

Shoulder Pain Chronic

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Hıgh İntensity Laser (HILT)
Ultrasound
Hotpack
Transcutaneous electrical nerve stimulation
Therapeutic exercises
Balneotherapy
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain Chronic focused on measuring High Intensity Laser, Ultrasound, Chronic Shoulder Pain

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HILT group

US Group

Arm Description

71 of the patients were in the HILT group

70 of the patients were in the US group.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2016
Last Updated
June 3, 2016
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02793401
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain Chronic
Keywords
High Intensity Laser, Ultrasound, Chronic Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HILT group
Arm Type
Active Comparator
Arm Description
71 of the patients were in the HILT group
Arm Title
US Group
Arm Type
Active Comparator
Arm Description
70 of the patients were in the US group.
Intervention Type
Device
Intervention Name(s)
Hıgh İntensity Laser (HILT)
Intervention Description
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
Intervention Name(s)
Ultrasound
Intervention Description
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
Intervention Name(s)
Hotpack
Intervention Description
All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
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
Other
Intervention Name(s)
Therapeutic exercises
Intervention Description
All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles
Intervention Type
Other
Intervention Name(s)
Balneotherapy
Intervention Description
All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.
Primary Outcome Measure Information:
Title
VAS
Description
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.
Time Frame
Change from Baseline in VAS scores at 15 days and 45 days
Title
SPADI
Description
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.
Time Frame
Change from Baseline in SPADI scores at 15 days and 45 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Metin Ökmen, MD
Organizational Affiliation
Bursa Yuksek Ihtisas Education and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, MD
Organizational Affiliation
Bursa Yuksek Ihtisas Education and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kağan Özkuk, MD
Organizational Affiliation
Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bilal Uysal, MD
Organizational Affiliation
Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Refia Sezer, MD
Organizational Affiliation
Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Engin Koyuncu, MD
Organizational Affiliation
Ankara Physical Therapy and Rehabilitation Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
City
Bursa
ZIP/Postal Code
16320
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

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