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

NCT ID: NCT01911806

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Back care pillow

Intervention Type: 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

standard physical therapy treatment

Intervention Type: PROCEDURE

standard physical therapy treatment are ultrasound therapy and hot pack

standard physical therapy treatment

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

Group Type: ACTIVE_COMPARATOR

standard physical therapy treatment

Intervention Type: PROCEDURE

standard physical therapy treatment are ultrasound therapy and hot pack

Interventions

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

Intervention Type: DEVICE

standard physical therapy treatment

standard physical therapy treatment are ultrasound therapy and hot pack

Intervention Type: PROCEDURE

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)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Bundit Prommanon

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

Other Identifiers

MRG555S021

Identifier Type: -

Identifier Source: org_study_id