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PainBack3monthsNCT05226156

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

An observational study of Pain and Physical Function, run by Joint Academy at 1 site in Sweden.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Physical Function
What is being tested?
Digitally delivered exercise and education treatment Joint Academy
How many people
2,593 participants
Where
1 siteSweden
Study dates
27 Apr 2021to 16 Mar 2022
Phase
Observational
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

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.

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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Arthro Therapeutics

    Malmö, 21134

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Digitally delivered exercise and education treatment Joint Academy
Keywords
Low back pain, Pain, Exercise, Physiotherapy, Telehealth, Digital treatment
Medical subject headings
Pain, Low Back Pain, Motor Activity

What participants receive

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

  • Digitally delivered exercise and education treatment Joint AcademyBehavioural

    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.

What is being measured

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

  1. Pain Numeric Rating Scale (NRS)

    Pain was assessed weekly using the Numerical Rating Scale (NRS), with the instruction "Mark on this scale how much pain you had the last week in your hip/knee", followed by a 0-10 scale where 0 indicates No pain and 10 indicates Maximum pain.

    Measured: Weekly change from baseline to three months

Secondary outcomes (3)

  1. Oswersty Disability Index (ODI)

    The ODI is divided into ten sections to assess the level of pain and interference with several activities including; sleep, self-care, sex life, social life and travelling. Each question has six possible responses which are scored from 0 to 5 (good to bad). The score for each section is added and divided by the total possible score (50 if all sections are completed), and the resulting score is multiplied by one hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.

    Measured: baseline and 3 months

  2. PASS

    Patient Acceptable Symtom State, descriptive, not link to other patient-reported outcome measures. PASS was assessed at follow-up with the question: "Considering your lower back function, do you feel that your current state is satisfactory? (yes/no). The PASS is a treatment-response criterion developed to determine the clinical relevance of a treatment effect. Answering no is referred to as PASS(-), yes is referred to as PASS (+), and changing from no at baseline to yes at 3 months as PASS(-to+).

    Measured: baseline and 3 months

  3. Radicular pain

    Radicular pain assessed with Numerical Rating Scale (NRS), with the instruction "Mark on this scale how much pain you had the last week in your hip/knee", followed by a 0-10 scale where 0 indicates No pain and 10 indicates Maximum pain.

    Measured: baseline and 3 months

Timeline

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

  1. First posted7 Feb 2022
  2. Study start27 Apr 2021
  3. Primary completion15 Mar 2022
  4. Study completion16 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,593 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226156
Sponsor's protocol ID
Back study 3 months
Acronym
Back3months
Status last verified
May 2022
First submitted
26 Jan 2022
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data can be made available on request: either pseudonymized (coded) or aggregated original data, or of analyses performed.

Publications

  • 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.

    PubMed 35727622

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Physical Function, run by Joint Academy at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 15 Dec 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 Sweden. 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?

Pain Numeric Rating Scale (NRS) (time frame: Weekly change from baseline to three 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 NCT05226156, which also lists 1 linked publication.

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 15 Dec 2022.

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