NCT05226156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,593

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

December 15, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

January 26, 2022

Last Update Submit

December 14, 2022

Conditions

Keywords

Low back painPainExercisePhysiotherapyTelehealthDigital treatment

Outcome Measures

Primary Outcomes (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.

    Weekly change from baseline to three months

Secondary Outcomes (3)

  • Oswersty Disability Index (ODI)

    baseline and 3 months

  • PASS

    baseline and 3 months

  • Radicular pain

    baseline and 3 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • \< age 18 years
  • \* Pregnancy
  • Concerns of low back pain due to "red flags" (e. g cancer, fracture, infection, cauda equina syndrome)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthro Therapeutics

Malmo, 21134, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

PainLow Back PainMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainBehavior

Study Officials

  • Leif E Dahlberg, Senior professor

    Arthro Therapeutics /Joint Academy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

April 27, 2021

Primary Completion

March 15, 2022

Study Completion

March 16, 2022

Last Updated

December 15, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Individual participant data can be made available on request: either pseudonymized (coded) or aggregated original data, or of analyses performed.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become available when the paper has been submitted and accepted for publication and up to two years after that.
Access Criteria
Researchers can ask for access through contacting medical director and responsible researcher at Joint Academy.

Locations