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

Study Overview
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Brief Summary
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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
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Chronic Nonspecific Low Back Pain

Intervention / Treatment
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* Device: Back care pillow
* Procedure: standard physical therapy treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back care pillow & standard physical therapy treatment<br>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<br>* 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<br>Procedure: standard physical therapy treatment<br>* standard physical therapy treatment are ultrasound therapy and hot pack<br>|
| Active Comparator: standard physical therapy treatment<br>standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks | Procedure: standard physical therapy treatment<br>* standard physical therapy treatment are ultrasound therapy and hot pack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Numerical rating scale |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale of lumbar range of motion measure by Modified - Modified Schober Test |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back care pillow, chronic non-specific low back pain, randomized controlled trial