Clinical trial NCT05226156: Digitally Delivered Exercise and Education Treatment for Low Back Pain: 3 Months Follow-up
Official title: Digitally Delivered Exercise and Education Treatment for Low Back Pain: 3 Months Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Physical Function
Keywords: Low back pain
Pain
Exercise
Physiotherapy
Telehealth
Digital treatment
Lead sponsor: Joint Academy
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2022-02-07
Enrollment: 2593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that have taken part of the digitally delivered treatment program for low back pain are reqruited from the Joint Academy database.

Persons joined the program through recommendation by their local physiotherapist or via online advertisements and campaigns placed on search engines and social networks, or through their insurance company.

A majority of included participants had a clinical diagnosis of non-specific LBP (diagnose code ICD-10 M54.5) from a PT or physician. Individuals without a prior diagnosis had a clinical diagnosis confirmed by a PT via telephone or videocall, or if deemed necessary be recommended to seek face-to-face care before inclusion in the programme.

Brief summary: Exercise and education is recommended as the first-line treatment by evidence-based, international guidelines for low back pain (LBP). Despite consensus regarding treatment, there is a gap between guidelines and what is offered to patients and less than half of the patients with nonspecific low back pain receive proper first-line care.

The aim of this study was to examine the short-term effect in pain and function in people with nonspecific LBP, participating in the digitally delivered treatment program Joint Academy.

Detailed description: Low back pain (LBP) is the 4th leading cause of Disability Adjusted Life Years (DALYs) among adults aged 25-49.. According to evidence-based clinical guidelines, exercise and education constitute the first-line intervention. In an attempt to support the implementation of the guidelines, the BetterBack Modell of Care (MoC), a face-to-face concept including exercise and education, was developed and tested in primary care clinics in Sweden since 2017.

The BetterBack (MoC) is a package of education and training that includes structured assessment by a physiotherapist, information on cause and prognosis for LBP and individualised exercise. BetterBack has so far shown that physiotherapists experience increased self-efficacy for assessing and treating patients with LBP and that patients experience improved knowledge for self-care. Despite clinical guidelines for LBP, there is a gap between guidelines and what is offered to patients with LBP, and valuable health resources are still used for examinations and treatments that are proven ineffective or even harmful.

Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telehealth, defined as the 'delivery of healthcare at a distance using information and communication technology' (ICT) could be a solution to many access barriers and has been rapidly adopted by many healthcare professions and accelerating even more throughout the COVID-19 pandemic.

Literature investigating the use of telehealth for the management of musculoskeletal pain is growing. Systematic reviews have demonstrated that telehealth can provide improvements in pain, physical function and disability that are similar to that of usual face-to-face care for individuals with musculoskeletal conditions such as osteoarthritis and non-specific low back pain. The use of telehealth also seems to increase exercise adherence for a variety of musculoskeletal conditions. However, there is a vast heterogeneity between studies included in these systematic reviews with respect to the intervention (type of exercise and education) and the ICT strategy provided, highlighting the need for further evidence-based digital programs to strengthen these findings.

Joint Academy® (JA), a digitally delivered treatment program with exercise and education was developed to increase access to and facilitate implementation of guideline derived and evidence-based treatment for musculoskeletal pain. The first JA program was introduced in 2016 for persons with hip- and knee OA and showed reduced pain and improved function. A recent randomized controlled trial on patients with knee OA showed that the digital program was superior to usual care. During 2021, a similar programme for persons with LBP, inspired by the Swedish face-to-face Better Back MoC was introduced.

The purpose of this study was to evaluate 3-months changes in pain and function during participation in the digitally delivered Joint Academy® (JA) exercise and education treatment program for patients with low back pain. A second aim was to examine the association of sociodemographis, health-related and treatment-related factors with outcome.

Eligibility criteria: Absolute exclusion criteria

* \< age 18 years

  \* Pregnancy
* Concerns of low back pain due to "red flags" (e. g cancer, fracture, infection, cauda equina syndrome)

Relative (to be further examined before inclusion)

* Radiculopati
* Previous or current cancer or unvoluntary weight loss
* Opioid demanding pain or pain in rest (cancer?, fracture?, infection?)
* Inflammatory back pain (atypical pain)
* Older patients (\>75 years) with multiple disease
* Structural deformities (atypical pain)

Primary outcomes:
measure: Pain Numeric Rating Scale (NRS)
timeFrame: Weekly change from baseline to three months
Secondary outcomes:
measure: Oswersty Disability Index (ODI)
timeFrame: baseline and 3 months
measure: PASS
timeFrame: baseline and 3 months
measure: Radicular pain
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Arthro Therapeutics
Study officials:
affiliation: Arthro Therapeutics /Joint Academy
name: Leif E Dahlberg, Senior professor
role: STUDY_DIRECTOR
References:
citation: Horder H, Nero H, Misini Ignjatovic M, Kiadaliri A, Lohmander LS, Dahlberg LE, Abbott A. Digitally Delivered Exercise and Education Treatment Program for Low Back Pain: Longitudinal Observational Cohort Study. JMIR Rehabil Assist Technol. 2022 Jun 21;9(2):e38084. doi: 10.2196/38084.