Digitally Delivered Exercise and Education Treatment for Low Back Pain: 3 Months Follow-up

NCT ID: NCT05226156

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2593 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-27

Study Completion Date

2022-03-16

Brief Summary

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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

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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.

Conditions

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Pain Physical Function

Keywords

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Low back pain Pain Exercise Physiotherapy Telehealth Digital treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Digitally delivered exercise and education treatment Joint Academy

The Joint Academy® (www.jointacademy.com) program for people with LBP consists of video instructed and progressively adaptable daily exercises, patient education through text lessons and a continuous asynchronous chat function with a personal reg. physiotherapist who supervises the patient during the full participation period. The program also contains three telephone consultations with a physiotherapist that were compulsory, one at the start, one after six weeks and one after three month.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Joint Academy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leif E Dahlberg, Senior professor

Role: STUDY_DIRECTOR

Arthro Therapeutics /Joint Academy

Locations

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Arthro Therapeutics

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 35727622 (View on PubMed)

Other Identifiers

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Back study 3 months

Identifier Type: -

Identifier Source: org_study_id