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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04463043
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 279
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 22.7
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief 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 (e-Help) and usual care only.

Condition or Disease	Intervention/Treatment	Phase
Back Pain; Neck Pain	Device: SelfBACK app; Other: e-Help webpage; Other: Usual care	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 279 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: This study is a single-blinded trial. Participants and health personnel at the clinic will not be blinded to group allocation, whereas researchers performing the analysis and the interpretation of the results will be blinded to group allocation. Once the study is completed, the data will be extracted from the database in anonymized form for statistical analyses, i.e. all personal information that may identify specific participants or group allocation will be removed and the intervention and control groups will be randomly labelled as A, B and C.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 9, 2020
• Actual Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SelfBACK app The selfBACK app in addition to usual care	Device: SelfBACK app; 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.; Other: Usual care; Usual care refers to seeking care or receiving treatments or help as usual.
Active Comparator: e-Help webpage The e-Help webpage in addition to usual care	Other: e-Help webpage; 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.; Other: Usual care; Usual care refers to seeking care or receiving treatments or help as usual.
Active Comparator: Usual care Usual care only	Other: Usual care; Usual care refers to seeking care or receiving treatments or help as usual.

Outcome Measures

Primary Outcome Measures

1. Musculoskeletal Health Questionnaire (MSK-HQ) [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.

Secondary Outcome Measures

1. Pain-related disability for low back pain [Change from baseline to 3 months]

   Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.

2. Pain-related disability for neck pain [Change from baseline to 3 months]

   Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.

3. Average pain intensity [Change from baseline to 3 months]

   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'.

4. Worst pain intensity [Change from baseline to 3 months]

   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'.

5. Health related quality of life [Change from baseline to 3 months]

   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.

6. Pain self-efficacy [Change from baseline to 3 months]

   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.

7. Illness perception [Change from baseline to 3 months]

   The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.

Other Outcome Measures

1. Fear avoidance belief [Change from baseline to 3 months]

   The Fear-Avoidance Belief Questionnaire (FABQ) - physical activity subscale is used to measure participant's beliefs about how physical activity affect their low back and/or neck pain. 5 items scored 0 - 6

2. Stress symptoms [Change from baseline to 3 months]

   The Perceived Stress Scale (PSS) is used to evaluate stress levels. 10 items scored 0 - 4.

3. Depressive symptoms [Change from baseline to 3 months]

   The Patient Health Questionnaire-2 (PHQ-2) is used to evaluate patients' depressive symptoms. 2 items scored 0 - 3.

4. Functional change [Change from baseline to 3 months]

   The Patient Specific Functional Scale (PSFS) is used to evaluate changes in participant's ability to perform up to two self-selected activities regarded as important by them. Ability levels scored 0 - 10.

5. Self-reported physical activity [Change from baseline to 3 months]

   The modernised Saltin-Grimby Physical Activity Level Scale is used to evaluate self-reported leisure time physical activity. 1 item (4 options).

6. Self-reported sleep [Change from baseline to 3 months]

   Sleep problems are assessed by four self-report items which provide information needed to diagnose insomnia according to the DSM-V criteria. 4 items scored 0 - 2.

7. Work ability [Change from baseline to 3 months]

   Work ability index (WAI) is used to assess work ability. 1-item rated on an 11-point numeric rating scale (0='completely unable to work' to 10='work ability at its best').

8. Satisfaction with intervention [3 months]

   Patient Acceptable Symptom State (PASS) is used to determine if patients consider themselves well and, as such, are satisfied with the treatment. 1 item (yes/no)

9. Perceived effect [3 months]

   Patient's Global Perceived Effect is used to investigate participants' perception of effect from the intervention they received. 1 item scored -5 to 5

10. Health care consumption [1 year]

    Objective registry based data linked to social security number in Norway are used to investigate health care consumption.

11. Sickness absence [1 year]

    Objective registry based data linked to social security number in Norway are used to investigate sickness absence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital

Investigators

• Study Director: Siri Forsmo, phd prof, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NØ, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Børke 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.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04463043
• Other Study ID Numbers: 64084
• First Posted: Jul 9, 2020
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: self-management; rehabilitation; mHealth; eHealth
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of Nov 3, 2021