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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bundit Prommanon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01911806
First received: March 30, 2013
Last updated: August 23, 2014
Last verified: August 2014
  Purpose
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.

Condition Intervention Phase
Chronic Nonspecific Low Back Pain
Device: Back care pillow
Procedure: standard physical therapy treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Pain Scores on the Numerical rating scale [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scale of lumbar range of motion measure by Modified - Modified Schober Test [ Time Frame: three months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Roland-Morris Disability Questionnaires (RMDQ) [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911806

Locations
Thailand
School of physical therapy,Faculty of associated medical science,Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
  More Information

Responsible Party: Bundit Prommanon, school of physical therapy,Faculty of associated medical science,Khon Kaen University, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01911806     History of Changes
Other Study ID Numbers: MRG555S021 
Study First Received: March 30, 2013
Last Updated: August 23, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Back care pillow
chronic non-specific low back pain
randomized controlled trial

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 21, 2016