Low Back PainBACKSPINNCT04290078

The Kaia Back Pain Intervention for Self-management of Low Back Pain

A study testing Kaia Back Pain Study App in people with Low Back Pain, run by Kaia Health Software at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Low Back Pain
What is being tested?: Kaia Back Pain Study App
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 1 Aug 2021
Phase: Interventional
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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital /Physiatry, Spine & Pain Management
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: The Kaia Back Pain Intervention for Self-management of Low Back Pain - a Randomized Controlled Study

Read the 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.

Conditions: Low Back Pain
Being tested: Kaia Back Pain Study App, Usual Care
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kaia Back Pain Study AppDevice
Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.
Usual CareOther
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

Study groups in NCT04290078
Study group	Role	What they receive
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. Receives: Device: Kaia Back Pain Study App
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. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Numerical Rating Scale
Pain Intensity (NRS-11, 0 no pain to 10 Severe pain)
Measured: Change from baseline NRS at 90 days

Secondary outcomes (9)

Oswestry Disability Index
Measure of Disability in Low Back Pain ( Scale from "0%" no disability no to "100% worst possible disability" )
Measured: baseline (day 0), day 30, day 60 and day 90
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)
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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)
Measured: baseline (day 0), day 30, day 60 and day 90
Change in concomitant medication use
Record of intaken concomitant analgetic medication (number of uses)
Measured: 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
Measured: 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
Measured: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20201 Aug 2021

First posted28 Feb 2020
Study start1 Dec 2020
Primary completion1 Jun 2021 (estimated)
Study completion1 Aug 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: None (open label)
Enrolment: 184 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04290078
Sponsor's protocol ID: KaiaBP001
Acronym: BACKSPIN
Status last verified: Dec 2020
First submitted: 18 Feb 2020
Last updated: 8 Dec 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Kaia Back Pain Intervention for Self-management of Low Back Pain - a Randomized Controlled Study
ClinicalTrials.gov ID: NCT04290078
Acronym / sponsor ID: BACKSPIN / KaiaBP001
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 184 participants (estimated)
Lead sponsor: Kaia Health SoftwareIndustry (pharma, biotech, devices)
Collaborators: Brigham and Women's Hospital
Study start: 1 Dec 2020 (actual)
Primary completion: 1 Jun 2021 (estimated)
Study completion: 1 Aug 2021 (estimated)
First posted: 28 Feb 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Kaia Back Pain Study Intervention	Experimental	Device: Kaia Back Pain Study AppThe 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.
Control Group	Active comparator	Other: Usual CareParticipants 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.

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (10 listed)

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

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
Kaia Back Pain Study AppKaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.	Device	Kaia Back Pain Study Intervention
Usual CareParticipants 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	Other	Control Group

Primary outcome

Numerical Rating Scale
Time frame: Change from baseline NRS at 90 days
Pain Intensity (NRS-11, 0 no pain to 10 Severe pain)

9 secondary outcomes

Oswestry Disability Index
Time frame: baseline (day 0), day 30, day 60 and day 90
Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10)
Time frame: baseline (day 0), day 30, day 60 and day 90
Perceived Treatment Helpfulness
Time frame: baseline (day 0), day 30, day 60 and day 90
Pain Catastrophizing Scale
Time frame: baseline (day 0) and at day 90
Satisfaction and perceived treatment helpfulness
Time frame: Study End at day 90
Health care utilisation
Time frame: baseline (day 0), day 30, day 60 and day 90
Change in concomitant medication use
Time frame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
Number of Adverse Events
Time frame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
Number of Device Deficiencies
Time frame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Not yet recruiting
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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.

Assoc. Prof. Srdjan Nedeljkovic, MD principal investigator

Physiatry, Spine & Pain Management

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Kaia Back Pain Study App in people with Low Back Pain, run by Kaia Health Software 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 10 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. 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?

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?

Numerical Rating Scale (time frame: Change from baseline NRS at 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290078.

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 8 Dec 2020.