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

NCT01911806 | Completed Phase 2 DMC

• 1 other identifier: MRG555S021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Back care pillow; chronic non-specific low back pain; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Numerical rating scale

  three months

Secondary Outcomes (1)

• Scale of lumbar range of motion measure by Modified - Modified Schober Test

  three months

Other Outcomes (1)

• Roland-Morris Disability Questionnaires (RMDQ)

  three months

Study Arms (2)

Back care pillow & standard physical therapy treatment

EXPERIMENTAL

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; Procedure: standard physical therapy treatment

standard physical therapy treatment

ACTIVE COMPARATOR

standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks

Procedure: standard physical therapy treatment

Interventions

Back care pillow DEVICE

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

Back care pillow & standard physical therapy treatment

standard physical therapy treatment PROCEDURE

standard physical therapy treatment are ultrasound therapy and hot pack

Back care pillow & standard physical therapy treatment; standard physical therapy treatment

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

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

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: school of physical therapy,Faculty of associated medical science,Khon Kaen University

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: July 30, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

TH (1)