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Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714803
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE March 12, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
Change in low back pain intensity as measured by Visual Analog Scale [ Time Frame: Change from baseline low back pain intensity at 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Change in quality of life as assessed by Short Form-36 [ Time Frame: Change from baseline quality of life at 2 weeks ]
  • Change in functional statue as assessed by Oswestry Disability Index [ Time Frame: Change from baseline functional statue at 2 weeks ]
  • Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale [ Time Frame: Change from baseline psychologic statue at 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
Official Title  ICMJE Assistant Professor
Brief Summary The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: "Connective tissue massage" and "Conservative applications"
    Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
  • Behavioral: "Classic massage group" and "Conservative applications"
    Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
  • Behavioral: "Sham massage group" and "Conservative applications"
    Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
Study Arms  ICMJE
  • Experimental: Connective tissue massage group
    Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
    Intervention: Behavioral: "Connective tissue massage" and "Conservative applications"
  • Active Comparator: Classic massage group
    Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
    Intervention: Behavioral: "Classic massage group" and "Conservative applications"
  • Sham Comparator: Sham massage group
    Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
    Intervention: Behavioral: "Sham massage group" and "Conservative applications"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714803
Other Study ID Numbers  ICMJE 2015-11/33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
Study Sponsor  ICMJE Ataturk Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ataturk Training and Research Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP