Non-specific Chronic Low Back PainNCT02503410
An Interactive Gaming-based Intervention for Back Pain
A study testing Interactive gaming in people with Non-specific Chronic Low Back Pain, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- Interactive gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Back pain subject-rated > 3 on an 11 point visual-analog scale (0-10), with pain reported for a time > 6 months
- Able to commit to all study visits
- Low back pain attributable to mechanical etiology as opposed to infectious, neoplastic, or inflammatory causes.
- BMI ≤ 40
- Familiar with tablet use
Who cannot join
- Vision or mobility impairment interfering with the performance of the interactive games
- Current or anticipated receipt of payments from Worker's Compensation or other insurance for disability attributed to low back pain
- Additional treatment for back pain during the period of the study, such as acupuncture
- Unresolved musculoskeletal pathology of the lower limbs
- Severe radiculopathic pain
- Alcohol or substance abuse
Show all 20Show fewer
- Prior discectomy or implantation of rods, screws or plates (bulging disc without radicular pain is not exclusionary; hip or shoulder replacement is not exclusionary)
- Current medication with coumadin or prednisone, chronic use of steroid medications, daily use of narcotic analgesics, or estrogen supplementation, tricyclic anti-depressants (if not on a regular steady dose at least one month prior to enrollment), or any substance that could impair balance.
- Current diagnosis of:
- Balance problems due to vestibular or other neurological impairments.
- Osteoporosis (Osteopenia is not an exclusionary condition)
- Fibromyalgia
- Severe or progressive neurological deficits, including neuromotor impairment
- Any hypercoagulation condition
- Eczema, Psoriasis, or skin infections, and deep vein thrombosis
- Burns or other acute trauma including unhealed bone fractures or open wounds
- Psychiatric illness not well controlled, or current episode of exacerbated major depressive disorder
- Rheumatoid arthritis
- Any other major medical condition that would impair the subject's ability to complete the study visits
- Any other major medical condition that has not been stabilized, or that would impair the subject's ability to complete the activities required by the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
Official title: Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting
This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy.
Read the detailed description
The study relies upon the Valedo system by Hocoma AG to implement an interactive gaming-based intervention (i.e. subjects receive part of their physical therapy by playing interactive video games). The system is similar to consumer electronics products for interactive gaming that track the subject's movements using body-worn sensors. The FDA has determined that the Valedo system is a 510(K) exempt device under the product code ION (i.e. exerciser, non-measuring device for Physical Medicine). In the study, subjects with non-specific chronic low back pain are randomized using a block design to one of two groups: group 1 receives usual care alone; group 2 receives an exercise-based rehabilitation intervention using interactive gaming in addition to usual care. Clinical assessments are performed at baseline and again 4 weeks and 8 weeks after baseline measures are gathered.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- Usual care, Interactive gaming
- Keywords
- lower back, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.
Interactive gamingBehavioural
Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Subjects receive physical therapy for low back pain as typically prescribed in the clinic. Receives: Behavioral: Usual care |
| Interactive gaming | Experimental | Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. Receives: Behavioral: Interactive gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Scale at 4 Weeks
Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).
Measured: Change from baseline in Visual Analogue Pain Scale score at 4 weeks
Visual Analogue Pain Scale at 8 Weeks
Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).
Measured: Change from baseline in VAS score at 8 weeks
Pain Frequency at 4 Weeks
Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
Measured: Change in pain frequency at 4 weeks
Pain Frequency at 8 Weeks
Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
Measured: Change in pain frequency at 8 weeks
Secondary outcomes (4)
Oswestry Low Back Pain Disability Questionnaire at 4 Weeks
Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound.
Measured: Change in disability score at 4 weeks
Oswestry Low Back Pain Disability Questionnaire at 8 Weeks
Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound.
Measured: Change in disability score at 8 weeks
SF36 at 4 Weeks
The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100.
Measured: Change in clinical score at 4 weeks
SF36 at 8 Weeks
The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100
Measured: Change in clinical score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Lack of funding to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503410
- Sponsor's protocol ID
- 2015-P-000663
- Status last verified
- May 2019
- First submitted
- 10 Jul 2015
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting
- ClinicalTrials.gov ID
- NCT02503410
- Acronym / sponsor ID
- 2015-P-000663
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- lower back, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to continue the study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 28 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy.
Detailed description
The study relies upon the Valedo system by Hocoma AG to implement an interactive gaming-based intervention (i.e. subjects receive part of their physical therapy by playing interactive video games). The system is similar to consumer electronics products for interactive gaming that track the subject's movements using body-worn sensors. The FDA has determined that the Valedo system is a 510(K) exempt device under the product code ION (i.e. exerciser, non-measuring device for Physical Medicine). In the study, subjects with non-specific chronic low back pain are randomized using a block design to one of two groups: group 1 receives usual care alone; group 2 receives an exercise-based rehabilitation intervention using interactive gaming in addition to usual care. Clinical assessments are performed at baseline and again 4 weeks and 8 weeks after baseline measures are gathered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual careSubjects receive physical therapy for low back pain as typically prescribed in the clinic. |
| Interactive gaming | Experimental | Behavioral: Interactive gamingSubjects participate in an intervention combining usual care and home-based exercises using the Valedo system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking
- Back pain subject-rated > 3 on an 11 point visual-analog scale (0-10), with pain reported for a time > 6 months
- Able to commit to all study visits
- Low back pain attributable to mechanical etiology as opposed to infectious, neoplastic, or inflammatory causes.
- BMI ≤ 40
Key exclusion criteria (20 listed)
- Vision or mobility impairment interfering with the performance of the interactive games
- Current or anticipated receipt of payments from Worker's Compensation or other insurance for disability attributed to low back pain
- Additional treatment for back pain during the period of the study, such as acupuncture
- Unresolved musculoskeletal pathology of the lower limbs
- Severe radiculopathic pain
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 |
|---|---|---|
| Usual careSubjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist. | Behavioural | Usual care |
| Interactive gamingSubjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system. | Behavioural | Interactive gaming |
Primary outcome
Visual Analogue Pain Scale at 4 Weeks
Time frame: Change from baseline in Visual Analogue Pain Scale score at 4 weeks
Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).
Visual Analogue Pain Scale at 8 Weeks
Time frame: Change from baseline in VAS score at 8 weeks
Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).
Pain Frequency at 4 Weeks
Time frame: Change in pain frequency at 4 weeks
Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
Pain Frequency at 8 Weeks
Time frame: Change in pain frequency at 8 weeks
Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
4 secondary outcomes
Oswestry Low Back Pain Disability Questionnaire at 4 Weeks
Time frame: Change in disability score at 4 weeks
Oswestry Low Back Pain Disability Questionnaire at 8 Weeks
Time frame: Change in disability score at 8 weeks
SF36 at 4 Weeks
Time frame: Change in clinical score at 4 weeks
SF36 at 8 Weeks
Time frame: Change in clinical score at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive gaming in people with Non-specific Chronic Low Back Pain, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 6 inclusion and 20 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 28 May 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Pain Scale at 4 Weeks (time frame: Change from baseline in Visual Analogue Pain Scale score at 4 weeks). The study lists 4 primary outcomes in all. 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 28 May 2019.