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N/A Completed N=140 Randomized Single-blind Treatment

Digital Care Program for Chronic Low Back Pain

Low Back Pain
Source: ClinicalTrials.gov NCT04808141 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Oswestry Disability Index Score (ODI) — 24.84; 25.34; 17.94; 18.99 units on a scale — p=0.412

Summary

New ways of delivering care are much needed to address chronic low back pain. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care program to address these needs. This study aims to assess the clinical outcomes of this rehabilitation program versus conventional physical therapy.

Outcome Measures

OutcomeResultp-value
PRIMARY
Oswestry Disability Index Score (ODI)		 24.84; 25.34; 17.94; 18.99; -6.90; -6.35 0.412
SECONDARY
Pain Level		 5.40; 5.49; 3.59; 3.38; -1.81; -2.11 0.666
SECONDARY
Work Productivity and Activity Impairment (WPAI) Overall		 25.61; 23.79; 16.87; 17.67; -8.74; -6.12 0.122
SECONDARY
Interest in Undergoing Surgery		 6.43; 9.76; 0.06; 0.06; -6.37; -9.69 0.788
SECONDARY
Medication Consumption		 9; 7 0.081
SECONDARY
Fear Avoidance Beliefs - Physical Activity (FABQ-PA)		 14.41; 13.99; 12.48; 12.48; -1.92; -1.50 0.871
SECONDARY
Anxiety		 3.79; 4.22; 2.51; 2.51; -1.28; -1.70 0.360
SECONDARY
Patient Satisfaction With Intervention		 8.4; 8.4 0.837
SECONDARY
Physical Activity Levels		 17; 14; 19; 16; 21; 15 0.886
SECONDARY
Depression		 4.09; 4.67; 3.22; 2.48; -0.87; -2.19 0.095
SECONDARY
Retention Rate		 57; 45 —
SECONDARY
Treatment Intensity		 451.78; 385.98 0.662
SECONDARY
Work Productivity and Activity Impairment (WPAI) Work		 23.52; 22.51; 15.33; 16.29; -8.19; -6.22 0.246
SECONDARY
Work Productivity and Activity Impairment (WPAI) Time		 3.35; 2.63; 0.00; 0.00; -3.36; -2.63 0.408
SECONDARY
Work Productivity and Activity Impairment (WPAI) Activity		 35.59; 36.73; 22.66; 23.45; -12.93; -13.28 0.650
SECONDARY
Dropout Rate		 11; 24 0.019 sig
SECONDARY
Total Sessions		 22.32; 12.42 —
SECONDARY
Frequency of Sessions Per Week		 2.79; 1.55 —

Eligibility Criteria

Inclusion Criteria

  • Subjects aged between 18 and 80 years of age at enrolment
  • Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
  • Ability to understand complex motor tasks

Exclusion Criteria

  • Known pregnancy
  • Submitted to spinal surgery less than 3 months ago
  • Symptoms and/or signs indicative of possible infectious disorder
  • Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome)
  • Cancer diagnosis or undergoing treatment for cancer
  • Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
  • Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson's disease)
  • Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
  • Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04808141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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