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Completed

NCT Number: NCT01911806

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

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.

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Key information

Conditions

Chronic Nonspecific Low Back Pain

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Physical Therapy Treatment

Procedure

standard physical therapy treatment are ultrasound therapy and hot pack

Primary outcomes

  1. Pain Scores on the Numerical rating scale

    Time frame: three months

Secondary outcomes

  1. Scale of lumbar range of motion measure by Modified - Modified Schober Test

    Time frame: three months

Other outcomes

  1. Roland-Morris Disability Questionnaires (RMDQ)

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2013
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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