- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125968
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Taipie, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- chronic low back pain
Exclusion Criteria:
- low back pain accompanied by specific pathological conditions, such as infection, inflammation, fracture, or tumor
- history of low back surgery with an implant
- pregnancy of plans to become pregnant during the course of study
- having received concurrent treatment for low back pain followed by another health care professional
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
short- and medium-term therapeutic effects
Other Names:
|
|
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. |
short- and medium-term therapeutic effects
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oswestry Disability Questionnaire
Time Frame: changes from baseline at one and three months after treatment
|
changes from baseline at one and three months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
range of motion
Time Frame: changes from baseline at one and three months after treatment
|
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
|
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
|
changes from baseline at one and three months after treatment
|
|
Fear avoidance Behavior Questionnaire
Time Frame: changes from baseline at one and three months after treatment
|
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
|
changes from baseline at one and three months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Oxymetazoline
Other Study ID Numbers
- SKH-8302-103-DR-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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