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

Chronic Nonspecific Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911806
• Other study ID #: MRG555S021
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 30, 2013
• Last updated: August 23, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Nonspecific Low Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Thailand	School of physical therapy,Faculty of associated medical science,Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Roland-Morris Disability Questionnaires (RMDQ)		three months	No
Primary	Pain Scores on the Numerical rating scale		three months	No
Secondary	Scale of lumbar range of motion measure by Modified - Modified Schober Test		three months	No