HeLP
Trial question
What is the effect of healthy lifestyle program in patients with chronic low back pain disability?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 344
344 patients (190 female, 154 male).
Inclusion criteria: patients with activity-limiting chronic low back pain and at least one lifestyle risk factor, such as overweight, poor diet, physical inactivity, and/or smoking.
Key exclusion criteria: unable to use telephone; currently undertaking weight management or smoking cessation programs; planned surgery in the next 6 months; pregnancy or planning pregnancy; comorbidity precluding understanding or participation in study procedures.
Interventions
N=172 healthy lifestyle program (guideline-based care with lifestyle education, resources, and behavior change self-management support).
N=172 guideline-based care (guideline-recommended advice and exercise).
Primary outcome
Mean low back pain disability score at 26 weeks
11.4 points
12.5 points
12.5 points
9.4 points
6.3 points
3.1 points
0.0 points
Healthy lifestyle
program
Guideline-based
care
Significant
decrease ▼
Significant decrease in mean low back pain disability score at 26 weeks (11.4 points vs. 12.5 points; MD -1.3, 95% CI -2.5 to -0.2).
Secondary outcomes
No significant difference in mean pain intensity score at 26 weeks (5.4 points vs. 5.6 points; MD -0.3, 95% CI -0.8 to 0.2).
Significantly greater reduction in mean self-reported weight at 26 weeks (0.1 kg vs. -1.8 kg; MD 1.6, 95% CI 0 to 3.2).
Significantly greater improvement in mean QoL-physical component score at week 26 (3.9 points vs. 2 points; MD 1.8, 95% CI 0.1 to 3.4).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with activity-limiting chronic low back pain and at least one lifestyle risk factor, such as overweight, poor diet, physical inactivity, and/or smoking, healthy lifestyle program was superior to guideline-based care with respect to mean low back pain disability score at 26 weeks.
Reference
Emma Mudd, Simon R E Davidson, Steven J Kamper et al. Healthy Lifestyle Care vs Guideline-Based Care for Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2453807.
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