Neck Pain Clinical Trial
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
NCT number | NCT04463043 |
Other study ID # | 64084 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2020 |
Est. completion date | December 3, 2021 |
Verified date | September 2022 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 294 |
Est. completion date | December 3, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fear avoidance belief | 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 | Change from baseline to 3 months | |
Other | Stress symptoms | The Perceived Stress Scale (PSS) is used to evaluate stress levels. 10 items scored 0 - 4. | Change from baseline to 3 months | |
Other | Depressive symptoms | The Patient Health Questionnaire-2 (PHQ-2) is used to evaluate patients' depressive symptoms. 2 items scored 0 - 3. | Change from baseline to 3 months | |
Other | Functional change | 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. | Change from baseline to 3 months | |
Other | Self-reported physical activity | The modernised Saltin-Grimby Physical Activity Level Scale is used to evaluate self-reported leisure time physical activity. 1 item (4 options). | Change from baseline to 3 months | |
Other | Self-reported sleep | 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. | Change from baseline to 3 months | |
Other | Work ability | 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'). | Change from baseline to 3 months | |
Other | Satisfaction with intervention | 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) | 3 months | |
Other | Perceived effect | Patient's Global Perceived Effect is used to investigate participants' perception of effect from the intervention they received. 1 item scored -5 to 5 | 3 months | |
Other | Health care consumption | Objective registry based data linked to social security number in Norway are used to investigate health care consumption. | 1 year | |
Other | Sickness absence | Objective registry based data linked to social security number in Norway are used to investigate sickness absence. | 1 year | |
Primary | 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. | Change from baseline to 3 months | |
Secondary | 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. | Change from baseline to 3 months | |
Secondary | 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. | Change from baseline to 3 months | |
Secondary | 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'. | Change from baseline to 3 months | |
Secondary | 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'. | Change from baseline to 3 months | |
Secondary | 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. | Change from baseline to 3 months | |
Secondary | 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. | Change from baseline to 3 months | |
Secondary | Illness perception | The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10. | Change from baseline to 3 months |
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