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

March 16, 2016 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

Assistant Professor

The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06800
        • Atatürk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connective tissue massage group
Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
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.
Active Comparator: Classic massage group
Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
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.
Sham Comparator: Sham massage group
Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in low back pain intensity as measured by Visual Analog Scale
Time Frame: Change from baseline low back pain intensity at 2 weeks
Change from baseline low back pain intensity at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life as assessed by Short Form-36
Time Frame: Change from baseline quality of life at 2 weeks
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 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
Change from baseline psychologic statue at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-11/33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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