What is this trial studying for low back pain?

This trial is studying whether a combined lifestyle intervention delivered by physio/exercise therapists improves physical functioning and activity in overweight or obese patients with persistent low back pain. The research aims to find out if integrating lifestyle changes into standard care can better manage low back pain and reduce healthcare costs over 36 months.

Who may be eligible for this low back pain clinical trial?

Adults aged 18 years or older with persistent low back pain lasting at least 3 months who are overweight or obese and referred back to primary care from the hospital may be eligible. They should have moderate pain and some loss of physical function. Please review eligibility criteria for more details.

Is there any cost to participate in this low back pain clinical trial?

Study-related care, including the study intervention and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06594796

A Combined Lifestyle Intervention Delivered by Physioexercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity a Randomized Controlled Trial with Parallel Economic Evaluation

Led by Willeke Boonstra · Updated on 2025-01-24

318

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain LBP who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physioexercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.

CONDITIONS

Brief Title

A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients with persistent (3 months or more) non-specific low back pain who are referred back from the hospital to primary care
Body mass index (BMI) of 30 or higher OR BMI of 25 or higher with at least one related condition such as osteoarthritis, sleep apnea, cardiovascular risk factors, or type 2 diabetes
Decreased physical functioning with a Roland Morris Disability Questionnaire score of 4 or higher out of 24
Average low back pain intensity of 3 or higher out of 10 over the past week
18 years old or older

You will not qualify if you...

Specific low back pain causes such as tumor or fracture
Back surgery in the past six months
Psychiatric diseases that could interfere with participation
Pregnancy or less than 9 months postpartum

Research Team

Gwendolyne Scholten-Peeters, PhD, PT

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