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Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02125968
Recruitment Status : Unknown
Verified April 2014 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Recruiting
First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborator:
Shin Kong Wu Ho-Su Memorial Hospital
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

Tracking Information
First Submitted Date  ICMJE April 23, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 29, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2014)
Oswestry Disability Questionnaire [ Time Frame: changes from baseline at one and three months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2014)
  • range of motion [ Time Frame: changes from baseline at one and three months after treatment ]
  • Hospital Anxiety and Depression Scale [ Time Frame: changes from baseline at one and three months after treatment ]
  • postural stability [ Time Frame: changes from baseline at one and three months after treatment ]
    postural stability, limits of stability, and fall risk measured by Biodex Stability System
  • Fear avoidance Behavior Questionnaire [ Time Frame: changes from baseline at one and three months after treatment ]
  • physical activity [ Time Frame: changes from baseline at one and three months after treatment ]
    timed stairs climbing, 10-m walking, chair-rising time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain
Official Title  ICMJE Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail
Brief Summary The purpose of this study is to investigate the video game play therapy in patients with chronic low back pain.
Detailed Description Understanding the short- and medium-term therapeutic effects of video game play therapy for patients with chronic low back pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Other: interactive video game
    short- and medium-term therapeutic effects
    Other Name: 6 sessions of 15-min, for a 2-week duration
  • Other: therapeutic exercise
    short- and medium-term therapeutic effects
    Other Name: 6 sessions of 15 min ,for a 2-week duration.
Study Arms  ICMJE
  • Active Comparator: interactive video game

    Participants in interactive video game group receive six 20-min sessions of hot pack therapy combined 20-min of diathermy therapy over the low back followed by 15-min interactive video game intervention, for 3 times per week for a 2-week duration.

    Short- and medium-term therapeutic effects of interactive video game intervention for patients with chronic low back pain will be assessed.

    Intervention: Other: interactive video game
  • Sham Comparator: therapeutic exercise

    Participants received six 20-min sessions of hot pack therapy combined 20-min of diathermy therapy over the low back followed by 15-min supervised therapeutic exercise,for 3 times per week for a 2-week duration.

    short- and medium-term therapeutic effects of video game play therapy for patients with chronic low back pain will be evaluated.

    Intervention: Other: therapeutic exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 26, 2014)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • chronic low back pain

Exclusion Criteria:

  1. low back pain accompanied by specific pathological conditions, such as infection, inflammation, fracture, or tumor
  2. history of low back surgery with an implant
  3. pregnancy of plans to become pregnant during the course of study
  4. having received concurrent treatment for low back pain followed by another health care professional
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02125968
Other Study ID Numbers  ICMJE SKH-8302-103-DR-36
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ru-Lan Hsieh, Taipei Medical University
Study Sponsor  ICMJE Taipei Medical University
Collaborators  ICMJE Shin Kong Wu Ho-Su Memorial Hospital
Investigators  ICMJE
Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital
PRS Account Taipei Medical University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP