Back to resultsThe Kaia Back Pain Intervention for Self-management of Low Back Pain (BACKSPIN)
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kaia Back Pain Study App
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Between 22 and 75 years old
- Able to speak, read, and understand English
- Smartphone user with a compatible device, built-in camera, and internet access at home
- Pain intensity ≥4/10 on Numeric Rating Scale (NRS) for low back pain, on average, in the week prior to screening
- Low back pain diagnosis with duration ≥1 month and <12 months (i.e., non-specific subacute or chronic back pain)
- Willingness and capable of providing Informed Consent to use the Kaia Study app and participate in all assessments associated with this clinical study
Exclusion Criteria:
- Referral or plans for surgery, chiropractic care, acupuncture, injections or other treatment for low back pain in the next 1 month following screening
- Self-reported prior subscription to Kaia app or plans to participate in any other investigational trials or protocols for low back pain within 90 days
- Known pregnancy at screening or plans to become pregnant during study.
- Prior back surgery or current workers compensation case or litigation related to back pain
- Self-reported ongoing use of opioids for conditions other than back pain within 30 days prior to screening
- If taking opioid or NSAID medication for back pain, changes in dosing or type of medications used for analgesic regimen within 30 days prior to screening
- Use of opioids greater than the following daily doses: oxycodone >20 mg per day, morphine > 30 mg per day, hydrocodone > 30 mg per day, or tramadol > 300 mg per day within 30 days prior to screening
- Self-reported history of substance abuse within 1 year
- Diagnosis of specific underlying cause of back pain (e.g., known spinal fracture, spinal tumor, spinal infection, disc herniation, spinal stenosis)
- Severe or unstable medical condition (e.g., unstable cardiac disease, active infection, stroke with residual neuromuscular effects, paralysis, gait imbalance, or history of recent recurrent falls)
Sites / Locations
- Brigham and Women's Hospital /Physiatry, Spine & Pain Management
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kaia Back Pain Study Intervention
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Numerical Rating Scale
Pain Intensity (NRS-11, 0 no pain to 10 Severe pain)
Secondary Outcome Measures
Oswestry Disability Index
Measure of Disability in Low Back Pain ( Scale from "0%" no disability no to "100% worst possible disability" )
Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10)
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)
Perceived Treatment Helpfulness
Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")
Pain Catastrophizing Scale
Quantify individual's pain catastrophizing (scored from 0 "no catastrophizing" to 52 "worst possible catastrophizing")
Satisfaction and perceived treatment helpfulness
Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")
Health care utilisation
Use of services by persons for the purpose of preventing and curing health problems (type and number of times utilized)
Change in concomitant medication use
Record of intaken concomitant analgetic medication (number of uses)
Number of Adverse Events
Absolute number of untoward medical occurrences
Number of Device Deficiencies
Absolute number of untoward technical occurrences
Full Information
NCT ID
NCT04290078
First Posted
February 18, 2020
Last Updated
December 7, 2020
Sponsor
Kaia Health Software
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04290078
Brief Title
The Kaia Back Pain Intervention for Self-management of Low Back Pain
Acronym
BACKSPIN
Official Title
The Kaia Back Pain Intervention for Self-management of Low Back Pain - a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaia Health Software
Collaborators
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kaia Back Pain Study Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kaia Back Pain Study App
Intervention Description
Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Numerical Rating Scale
Description
Pain Intensity (NRS-11, 0 no pain to 10 Severe pain)
Time Frame
Change from baseline NRS at 90 days
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Measure of Disability in Low Back Pain ( Scale from "0%" no disability no to "100% worst possible disability" )
Time Frame
baseline (day 0), day 30, day 60 and day 90
Title
Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10)
Description
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)
Time Frame
baseline (day 0), day 30, day 60 and day 90
Title
Perceived Treatment Helpfulness
Description
Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")
Time Frame
baseline (day 0), day 30, day 60 and day 90
Title
Pain Catastrophizing Scale
Description
Quantify individual's pain catastrophizing (scored from 0 "no catastrophizing" to 52 "worst possible catastrophizing")
Time Frame
baseline (day 0) and at day 90
Title
Satisfaction and perceived treatment helpfulness
Description
Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")
Time Frame
Study End at day 90
Title
Health care utilisation
Description
Use of services by persons for the purpose of preventing and curing health problems (type and number of times utilized)
Time Frame
baseline (day 0), day 30, day 60 and day 90
Title
Change in concomitant medication use
Description
Record of intaken concomitant analgetic medication (number of uses)
Time Frame
baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
Title
Number of Adverse Events
Description
Absolute number of untoward medical occurrences
Time Frame
baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
Title
Number of Device Deficiencies
Description
Absolute number of untoward technical occurrences
Time Frame
baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 22 and 75 years old
Able to speak, read, and understand English
Smartphone user with a compatible device, built-in camera, and internet access at home
Pain intensity ≥4/10 on Numeric Rating Scale (NRS) for low back pain, on average, in the week prior to screening
Low back pain diagnosis with duration ≥1 month and <12 months (i.e., non-specific subacute or chronic back pain)
Willingness and capable of providing Informed Consent to use the Kaia Study app and participate in all assessments associated with this clinical study
Exclusion Criteria:
Referral or plans for surgery, chiropractic care, acupuncture, injections or other treatment for low back pain in the next 1 month following screening
Self-reported prior subscription to Kaia app or plans to participate in any other investigational trials or protocols for low back pain within 90 days
Known pregnancy at screening or plans to become pregnant during study.
Prior back surgery or current workers compensation case or litigation related to back pain
Self-reported ongoing use of opioids for conditions other than back pain within 30 days prior to screening
If taking opioid or NSAID medication for back pain, changes in dosing or type of medications used for analgesic regimen within 30 days prior to screening
Use of opioids greater than the following daily doses: oxycodone >20 mg per day, morphine > 30 mg per day, hydrocodone > 30 mg per day, or tramadol > 300 mg per day within 30 days prior to screening
Self-reported history of substance abuse within 1 year
Diagnosis of specific underlying cause of back pain (e.g., known spinal fracture, spinal tumor, spinal infection, disc herniation, spinal stenosis)
Severe or unstable medical condition (e.g., unstable cardiac disease, active infection, stroke with residual neuromuscular effects, paralysis, gait imbalance, or history of recent recurrent falls)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc. Prof. Srdjan Nedeljkovic, MD
Organizational Affiliation
Physiatry, Spine & Pain Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital /Physiatry, Spine & Pain Management
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Kaia Back Pain Intervention for Self-management of Low Back Pain
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