Chronic Low Back PainPhase 4NCT02125968
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain
A Phase 4 study testing interactive video game and therapeutic exercise in people with Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the video game play therapy in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- interactive video game and therapeutic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail
The purpose of this study is to investigate the video game play therapy in patients with chronic low back pain.
Read the detailed description
Understanding the short- and medium-term therapeutic effects of video game play therapy for patients with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- interactive video game, therapeutic exercise
- Keywords
- chronic low back pain, video game, therapeutic effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive video gameOther
Also called 6 sessions of 15-min, for a 2-week duration
short- and medium-term therapeutic effects
therapeutic exerciseOther
Also called 6 sessions of 15 min ,for a 2-week duration.
short- and medium-term therapeutic effects
| Study group | Role | What they receive |
|---|---|---|
| interactive video game | Active comparator | 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. Receives: Other: interactive video game |
| therapeutic exercise | Sham comparator | 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. Receives: Other: therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Questionnaire
Measured: changes from baseline at one and three months after treatment
Secondary outcomes (5)
range of motion
Measured: changes from baseline at one and three months after treatment
Hospital Anxiety and Depression Scale
Measured: changes from baseline at one and three months after treatment
postural stability
postural stability, limits of stability, and fall risk measured by Biodex Stability System
Measured: changes from baseline at one and three months after treatment
Fear avoidance Behavior Questionnaire
Measured: changes from baseline at one and three months after treatment
physical activity
timed stairs climbing, 10-m walking, chair-rising time
Measured: changes from baseline at one and three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125968
- Sponsor's protocol ID
- SKH-8302-103-DR-36
- Status last verified
- Aug 2023
- First submitted
- 23 Apr 2014
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT02125968
- Acronym / sponsor ID
- SKH-8302-103-DR-36
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, video game, therapeutic effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive video game | Active comparator | Other: interactive video gameParticipants 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. |
| therapeutic exercise | Sham comparator | Other: therapeutic exerciseParticipants 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic low back pain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive video gameAlso: 6 sessions of 15-min, for a 2-week durationshort- and medium-term therapeutic effects | Other | interactive video game |
| therapeutic exerciseAlso: 6 sessions of 15 min ,for a 2-week duration.short- and medium-term therapeutic effects | Other | therapeutic exercise |
Primary outcome
Oswestry Disability Questionnaire
Time frame: changes from baseline at one and three months after treatment
5 secondary outcomes
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Related trials for Chronic Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing interactive video game and therapeutic exercise in people with Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Questionnaire (time frame: changes from baseline at one and three months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.