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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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The study aims to evaluate outcomes of the use of Kaia Study app (software program application for self-management of low-back pain) on back pain among adults with non-specific subacute and chronic low back pain based on change in pain intensity, physical functioning, quality of life (PROMIS-10) based on self-reported information from baseline to study end as compared to a control group.
This is a two-arm, parallel assignment, open-label, randomized control trial comparing back pain outcomes in an intervention group (MPT using the Kaia app) to those of a control group (usual care without restrictions on treatment). It is designed to enroll up to 184 participants. The treatment period will last for 90 days. This includes the randomization assignment and follow-up evaluations at 30 days, 60 days, and 90 days post-randomization. After pre-screening and informed consent activities are completed, the study will be conducted using electronic patient reported outcomes (ePROs); participants can complete all study tasks at home by means of internet-enabled devices. Participants assigned to the intervention group will implement Kaia's exercise regimen using their personal mobile devices. The control group will receive usual care without restrictions and will be provided with internet-based information about treatment of non-specific back pain, including handouts depicting typical home-based exercises as recommended by American Academy of Orthopedic Surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kaia Back Pain Study Intervention | Experimental | The study intervention consists of training sessions conducted daily by the participant via Kaia back pain program. This content combines several approaches that may be effective when used together such as physical exercises, relaxation practices and learning modules. Additionally, there is availability of an electronic motion coach on a set of exercises. Users also receive behavioural health coaching provided by Kaia's coaching staff based on a coaching curriculum. |
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| Control Group | Active Comparator | Participants in the control arm will be provided with online links to educational materials about home exercises and pain management and asked to continue their usual care. On-line resources will include links to Web MD, the National Library of Medicine (Medline), and OnHealth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kaia Back Pain Study App | Device | Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application. |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale | Pain Intensity (NRS-11, 0 no pain to 10 Severe pain) | Change from baseline NRS at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | Measure of Disability in Low Back Pain ( Scale from "0%" no disability no to "100% worst possible disability" ) | baseline (day 0), day 30, day 60 and day 90 |
| Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Assoc. Prof. Srdjan Nedeljkovic, MD | Physiatry, Spine & Pain Management | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital /Physiatry, Spine & Pain Management | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Usual Care | Other | Participants in the control arm will be provided with online links to educational materials about home exercises and pain management and asked to continue their usual care. On-line resources will include links to Web MD, the National Library of Medicine (Medline), and OnHealth |
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Quality of Life and overall Health Status (scores are transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health) |
| baseline (day 0), day 30, day 60 and day 90 |
| Perceived Treatment Helpfulness | Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction") | baseline (day 0), day 30, day 60 and day 90 |
| Pain Catastrophizing Scale | Quantify individual's pain catastrophizing (scored from 0 "no catastrophizing" to 52 "worst possible catastrophizing") | baseline (day 0) and at day 90 |
| Satisfaction and perceived treatment helpfulness | Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction") | Study End at day 90 |
| Health care utilisation | Use of services by persons for the purpose of preventing and curing health problems (type and number of times utilized) | baseline (day 0), day 30, day 60 and day 90 |
| Change in concomitant medication use | Record of intaken concomitant analgetic medication (number of uses) | baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90 |
| Number of Adverse Events | Absolute number of untoward medical occurrences | baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90 |
| Number of Device Deficiencies | Absolute number of untoward technical occurrences | baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |