Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment

August 23, 2014 updated by: Bundit Prommanon, Khon Kaen University
This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 3

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

  • Thailand
      • Khon Kaen, Thailand, 40002
        • School of physical therapy,Faculty of associated medical science,Khon Kaen University

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

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females
  • Age 20 - 69 years old.
  • Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day
  • Patients with low back pain who have pain for more than 3 months
  • Patients have pain at lower back without refer to leg
  • Patients have moderate to severe pain of numerical rating scale (pain score ≥ 4)

Exclusion Criteria:

  • Pregnant patients
  • Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery
  • Patients have Quada equine syndrome

  • Patients with nerve root symptoms (neurological deficit)

    1. Patient have refer pain to leg area of same dermatome is problem.
    2. Abnormal reflex of lower extremity.
    3. Muscle weakness of area myotome is problem.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Back care pillow & standard physical therapy treatment
standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks & back care pillow use during the day for 2 weeks
Device: Back care pillow
back care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees
Procedure: standard physical therapy treatment
standard physical therapy treatment are ultrasound therapy and hot pack
Active Comparator: standard physical therapy treatment
standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks
Procedure: standard physical therapy treatment
standard physical therapy treatment are ultrasound therapy and hot pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores on the Numerical rating scale
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Scale of lumbar range of motion measure by Modified - Modified Schober Test
Time Frame: three months
three months

Other Outcome Measures

Outcome Measure
Time Frame
Roland-Morris Disability Questionnaires (RMDQ)
Time Frame: three months
three months

Collaborators and Investigators

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

Sponsor

Khon Kaen University

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, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 30, 2013

First Submitted That Met QC Criteria

July 28, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 23, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRG555S021

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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