Back to resultsEffectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
Primary Purpose
Chronic Nonspecific Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Back care pillow
standard physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring Back care pillow, chronic non-specific low back pain, randomized controlled trial
Eligibility Criteria
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)
- Patient have refer pain to leg area of same dermatome is problem.
- Abnormal reflex of lower extremity.
- Muscle weakness of area myotome is problem.
Sites / Locations
- School of physical therapy,Faculty of associated medical science,Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Back care pillow & standard physical therapy treatment
standard physical therapy treatment
Arm Description
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
standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks
Outcomes
Primary Outcome Measures
Pain Scores on the Numerical rating scale
Secondary Outcome Measures
Scale of lumbar range of motion measure by Modified - Modified Schober Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01911806
Brief Title
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
Back care pillow, chronic non-specific low back pain, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Back care pillow & standard physical therapy treatment
Arm Type
Experimental
Arm Description
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
Arm Title
standard physical therapy treatment
Arm Type
Active Comparator
Arm Description
standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks
Intervention Type
Device
Intervention Name(s)
Back care pillow
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
standard physical therapy treatment
Intervention Description
standard physical therapy treatment are ultrasound therapy and hot pack
Primary Outcome Measure Information:
Title
Pain Scores on the Numerical rating scale
Time Frame
three months
Secondary Outcome Measure Information:
Title
Scale of lumbar range of motion measure by Modified - Modified Schober Test
Time Frame
three months
Other Pre-specified Outcome Measures:
Title
Roland-Morris Disability Questionnaires (RMDQ)
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Patient have refer pain to leg area of same dermatome is problem.
Abnormal reflex of lower extremity.
Muscle weakness of area myotome is problem.
Facility Information:
Facility Name
School of physical therapy,Faculty of associated medical science,Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
We'll reach out to this number within 24 hrs