Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
"Connective tissue massage" and "Conservative applications"
"Classic massage group" and "Conservative applications"
"Sham massage group" and "Conservative applications"
Sponsored by

About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
- Willing to participate
Exclusion Criteria:
- Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
- neurological disease;
- psychiatric disease;
- serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
- pregnant during the study
Sites / Locations
- Ataturk Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Connective tissue massage group
Classic massage group
Sham massage group
Arm Description
Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Outcomes
Primary Outcome Measures
Change in low back pain intensity as measured by Visual Analog Scale
Secondary Outcome Measures
Change in quality of life as assessed by Short Form-36
Change in functional statue as assessed by Oswestry Disability Index
Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale
Full Information
NCT ID
NCT02714803
First Posted
March 12, 2016
Last Updated
March 16, 2016
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02714803
Brief Title
Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
Official Title
Assistant Professor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue massage group
Arm Type
Experimental
Arm Description
Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Arm Title
Classic massage group
Arm Type
Active Comparator
Arm Description
Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Arm Title
Sham massage group
Arm Type
Sham Comparator
Arm Description
Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
Intervention Type
Behavioral
Intervention Name(s)
"Connective tissue massage" and "Conservative applications"
Intervention Description
Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
"Classic massage group" and "Conservative applications"
Intervention Description
Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
"Sham massage group" and "Conservative applications"
Intervention Description
Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
Primary Outcome Measure Information:
Title
Change in low back pain intensity as measured by Visual Analog Scale
Time Frame
Change from baseline low back pain intensity at 2 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life as assessed by Short Form-36
Time Frame
Change from baseline quality of life at 2 weeks
Title
Change in functional statue as assessed by Oswestry Disability Index
Time Frame
Change from baseline functional statue at 2 weeks
Title
Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale
Time Frame
Change from baseline psychologic statue at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
Willing to participate
Exclusion Criteria:
Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
neurological disease;
psychiatric disease;
serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
pregnant during the study
Facility Information:
Facility Name
Ataturk Training and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06800
Country
Turkey
12. IPD Sharing Statement
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Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
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