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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
Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 12, 2016
Last Updated
March 16, 2016
Sponsor
Ataturk Training and Research Hospital
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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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