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

Primary Purpose

Chronic Low Back Pain

Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
interactive video game
therapeutic exercise
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain, video game, therapeutic effects

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

interactive video game

therapeutic exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Oswestry Disability Questionnaire

Secondary Outcome Measures

range of motion
Hospital Anxiety and Depression Scale
postural stability
postural stability, limits of stability, and fall risk measured by Biodex Stability System
Fear avoidance Behavior Questionnaire
physical activity
timed stairs climbing, 10-m walking, chair-rising time

Full Information

First Posted
April 23, 2014
Last Updated
August 10, 2023
Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02125968
Brief Title
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain
Official Title
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain, video game, therapeutic effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interactive video game
Arm Type
Active Comparator
Arm Description
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.
Arm Title
therapeutic exercise
Arm Type
Sham Comparator
Arm Description
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 Type
Other
Intervention Name(s)
interactive video game
Other Intervention Name(s)
6 sessions of 15-min, for a 2-week duration
Intervention Description
short- and medium-term therapeutic effects
Intervention Type
Other
Intervention Name(s)
therapeutic exercise
Other Intervention Name(s)
6 sessions of 15 min ,for a 2-week duration.
Intervention Description
short- and medium-term therapeutic effects
Primary Outcome Measure Information:
Title
Oswestry Disability Questionnaire
Time Frame
changes from baseline at one and three months after treatment
Secondary Outcome Measure Information:
Title
range of motion
Time Frame
changes from baseline at one and three months after treatment
Title
Hospital Anxiety and Depression Scale
Time Frame
changes from baseline at one and three months after treatment
Title
postural stability
Description
postural stability, limits of stability, and fall risk measured by Biodex Stability System
Time Frame
changes from baseline at one and three months after treatment
Title
Fear avoidance Behavior Questionnaire
Time Frame
changes from baseline at one and three months after treatment
Title
physical activity
Description
timed stairs climbing, 10-m walking, chair-rising time
Time Frame
changes from baseline at one and three months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipie
ZIP/Postal Code
111-01
Country
Taiwan

12. IPD Sharing Statement

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

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