Back PainNCT04463043

An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation

A study testing SelfBACK app and e-Help webpage in people with Back Pain and Neck Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effectiveness of an individually tailored self-management intervention, the selfBACK app, in improving health status in patients on a waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a non-tailored web-based self-management solution… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Back Pain, Neck Pain
What is being tested?: SelfBACK app and e-Help webpage
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 294 participants
Where: 1 siteNorway
Study dates: 9 Jul 2020to 3 Dec 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

On waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway due to low back pain and/or neck pain
Own and use a smartphone with internet access to download the mobile application
Able to provide informed consent

Who cannot join

Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients prioritized for urgent treatment/examination)
Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
Unable to speak and/or read Norwegian
Unable to complete the baseline questionnaire

Trial locations and contacts

1 site in 1 country.

Norway1 site

Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital
Trondheim

Other trials in Norway

About this study

Official title: The Effectiveness of an App-based (selfBACK) Versus a Web-based (e-Help) Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation: a Three Arm Randomised Controlled Trial

Read the detailed description

Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway, due to low back and/or neck pain are the target group for this study. The average waiting time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial approach to support self-management during the waiting period. Therefore, the effectiveness of these tools in this patients group needs to be evaluated.

A total of 279 participants will be recruited and randomly allocated to one of the three groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to usual care; and 3) usual care only. Participants who receive either the selfBACK app and the e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.

Self-reported outcome measures will be collected through web-based questionnaires at three follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In addition, participants receiving the selfBACK app will be asked a set of weekly tailoring questions to individualize self-management plans. Objective registry based data linked to social security number in Norway will be used to investigate health care consumption and sickness absence at 1 year (and up to 5 years).

Conditions: Back Pain, Neck Pain
Being tested: SelfBACK app, e-Help webpage, Usual care
Keywords: self-management, rehabilitation, mHealth, eHealth
Medical subject headings: Back Pain, Neck Pain

What participants receive

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

SelfBACK appDevice
The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
e-Help webpageOther
The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
Usual careOther
Usual care refers to seeking care or receiving treatments or help as usual.

Study groups in NCT04463043
Study group	Role	What they receive
SelfBACK app	Experimental	The selfBACK app in addition to usual care Receives: Device: SelfBACK app; Other: Usual care
e-Help webpage	Active comparator	The e-Help webpage in addition to usual care Receives: Other: e-Help webpage; Other: Usual care
Usual care	Active comparator	Usual care only Receives: Other: Usual care

What is being measured

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

Musculoskeletal Health Questionnaire (MSK-HQ)
The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.
Measured: Change from baseline to 3 months

Secondary outcomes (7)

Pain-related disability for low back pain
Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.
Measured: Change from baseline to 3 months
Pain-related disability for neck pain
Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.
Measured: Change from baseline to 3 months
Average pain intensity
The average pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
Measured: Change from baseline to 3 months
Worst pain intensity
The worst pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
Measured: Change from baseline to 3 months
Health related quality of life
The EuroQoL 5-dimension (EQ-5D) questionnaire is used to assess health-related quality of life. 5 items scored 0 - 5 plus visual analogue scale scored 0- 100.
Measured: Change from baseline to 3 months
Pain self-efficacy
The Pain Self-Efficacy Questionnaire (PSEQ) is used to assess participants' level of confidence in carrying out specific activities despite their pain. 10 items scored 0 - 6.
Measured: Change from baseline to 3 months
Illness perception
The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.
Measured: Change from baseline to 3 months

Timeline

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

9 Jul 20203 Dec 2021

First posted9 Jul 2020
Study start9 Jul 2020
Primary completion1 Aug 2021
Study completion3 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for 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: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04463043
Sponsor's protocol ID: 64084
Status last verified: Sep 2022
First submitted: 18 Jun 2020
Last updated: 23 Sep 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data will be available, including data dictionaries. Data available to share include individual participant data collected during the trial, after deidentification.

Publications

Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.
PubMed 34518253
Marcuzzi A, Klevanger NE, Aasdahl L, Gismervik S, Bach K, Mork PJ, Nordstoga AL. An Artificial Intelligence-Based App for Self-Management of Low Back and Neck Pain in Specialist Care: Process Evaluation From a Randomized Clinical Trial. JMIR Hum Factors. 2024 Jul 9;11:e55716. doi: 10.2196/55716.
PubMed 38980710
Marcuzzi A, Nordstoga AL, Bach K, Aasdahl L, Nilsen TIL, Bardal EM, Boldermo NO, Falkener Bertheussen G, Marchand GH, Gismervik S, Mork PJ. Effect of an Artificial Intelligence-Based Self-Management App on Musculoskeletal Health in Patients With Neck and/or Low Back Pain Referred to Specialist Care: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320400. doi: 10.1001/jamanetworkopen.2023.20400.
PubMed 37368401

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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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of an App-based (selfBACK) Versus a Web-based (e-Help) Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation: a Three Arm Randomised Controlled Trial
ClinicalTrials.gov ID: NCT04463043
Acronym / sponsor ID: 64084
Conditions: Back Pain, Neck Pain
Keywords: self-management, rehabilitation, mHealth, eHealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Norwegian University of Science and TechnologyUniversity, hospital or other
Collaborators: St. Olavs Hospital
Study start: 9 Jul 2020 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 3 Dec 2021 (actual)
First posted: 9 Jul 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: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SelfBACK app	Experimental	Device: SelfBACK app, Other: Usual careThe selfBACK app in addition to usual care
e-Help webpage	Active comparator	Other: e-Help webpage, Other: Usual careThe e-Help webpage in addition to usual care
Usual care	Active comparator	Other: Usual careUsual care only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

On waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway due to low back pain and/or neck pain
Own and use a smartphone with internet access to download the mobile application
Able to provide informed consent

Key exclusion criteria (4 listed)

Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients prioritized for urgent treatment/examination)
Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
Unable to speak and/or read Norwegian
Unable to complete the baseline questionnaire

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
SelfBACK appThe selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.	Device	SelfBACK app
e-Help webpageThe e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.	Other	e-Help webpage
Usual careUsual care refers to seeking care or receiving treatments or help as usual.	Other	SelfBACK app, Usual care, e-Help webpage

Primary outcome

Musculoskeletal Health Questionnaire (MSK-HQ)
Time frame: Change from baseline to 3 months
The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.

7 secondary outcomes

Pain-related disability for low back pain
Time frame: Change from baseline to 3 months
Pain-related disability for neck pain
Time frame: Change from baseline to 3 months
Average pain intensity
Time frame: Change from baseline to 3 months
Worst pain intensity
Time frame: Change from baseline to 3 months
Health related quality of life
Time frame: Change from baseline to 3 months
Pain self-efficacy
Time frame: Change from baseline to 3 months
Illness perception
Time frame: Change from baseline to 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
Background: PubMed 34518253Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.
Derived from this study: PubMed 38980710Marcuzzi A, Klevanger NE, Aasdahl L, Gismervik S, Bach K, Mork PJ, Nordstoga AL. An Artificial Intelligence-Based App for Self-Management of Low Back and Neck Pain in Specialist Care: Process Evaluation From a Randomized Clinical Trial. JMIR Hum Factors. 2024 Jul 9;11:e55716. doi: 10.2196/55716.
Derived from this study: PubMed 37368401Marcuzzi A, Nordstoga AL, Bach K, Aasdahl L, Nilsen TIL, Bardal EM, Boldermo NO, Falkener Bertheussen G, Marchand GH, Gismervik S, Mork PJ. Effect of an Artificial Intelligence-Based Self-Management App on Musculoskeletal Health in Patients With Neck and/or Low Back Pain Referred to Specialist Care: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320400. doi: 10.1001/jamanetworkopen.2023.20400.
Individual participant dataSharing planned: Yes. Individual participant data will be available, including data dictionaries. Data available to share include individual participant data collected during the trial, after deidentification.

Related trials for Back Pain

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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.

Siri Forsmo, phd prof study director

Norwegian University of Science and Technology

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

Questions about this trial

What is this clinical trial studying?

A study testing SelfBACK app and e-Help webpage in people with Back Pain and Neck Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

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 3 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: finished, as of the sponsor's last update on 23 Sep 2022. 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 Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Musculoskeletal Health Questionnaire (MSK-HQ) (time frame: Change from baseline to 3 months). 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 NCT04463043, which also lists 3 linked publications.

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 23 Sep 2022.