Clinical trial NCT04824248: Weight Reduction in CLBP
Official title: The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Overweight or Obesity
Keywords: chronic low back pain
chronic pain
physiotherapy
physical therapy
weight reduction
pain management
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Rotterdam University of Applied Sciences
First posted: 2021-04-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Primary purpose: TREATMENT

Brief summary: We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.


Eligibility criteria: Inclusion Criteria:

* Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain
* Non-specific low back pain for at least 3 months' duration
* Currently seeking care for low back pain
* Native Dutch speaker
* Access to internet and computer/tablet/smartphone

Exclusion Criteria:

* Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
* Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
* Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
* BMI ≥ 40 kg/m2
* Being pregnant or given birth in the preceding year
* Currently receiving dietary or exercise interventions

Primary outcomes:
measure: Brief Pain inventory (BPI)
timeFrame: Change from baseline to 6 months (T3) after therapy completion
measure: Brief Pain inventory (BPI)
timeFrame: Difference between groups at 6 months (T3) after therapy completion
Secondary outcomes:
measure: Brief Pain inventory (BPI)
timeFrame: Baseline assessment (T0)
measure: Brief Pain inventory (BPI)
timeFrame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)
measure: Brief Pain inventory (BPI)
timeFrame: T2-assessment 3 months after therapy completion
measure: Brief Pain inventory (BPI)
timeFrame: T3-assessment 6 months after therapy completion
measure: Central sensitization inventory (CSI)
timeFrame: Baseline Assessment (T0)
measure: Central sensitization inventory (CSI)
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: Central sensitization inventory (CSI)
timeFrame: T2-assessment 3 months after therapy completion
measure: Central sensitization inventory (CSI)
timeFrame: T3-assessment 6 months after therapy completion
measure: TANITA Bio-electrical Impedance Analyzer
timeFrame: Baseline assessment (T0)
measure: TANITA Bio-electrical Impedance Analyzer
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: TANITA Bio-electrical Impedance Analyzer
timeFrame: T3-assessment 6 months after therapy completion
measure: SECA wall-fixed SECA wall-fixed stadiometer
timeFrame: Baseline measurement
measure: SECA wall-fixed SECA wall-fixed stadiometer
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: SECA wall-fixed SECA wall-fixed stadiometer
timeFrame: T3-assessment 6 months after therapy completion
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
timeFrame: Baseline
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
timeFrame: T3-assessment 6 months after therapy completion
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
timeFrame: Baseline
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
timeFrame: T3-assessment 6 months after therapy completion
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
timeFrame: Baseline
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
timeFrame: T3-assessment 6 months after therapy completion
measure: Food Frequency Questionnaire
timeFrame: Baseline
measure: Food Frequency Questionnaire
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: Food Frequency Questionnaire
timeFrame: T2-assessment 3 months after therapy completion
measure: Food Frequency Questionnaire
timeFrame: T3-assessment 6 months after therapy completion
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: T2-assessment 3 months after therapy completion
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: T3-assessment 6 months after therapy completion
measure: Sedentary Behavior Questionnaire of Busschaert et a
timeFrame: Baseline
measure: Sedentary Behavior Questionnaire of Busschaert et a
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: Sedentary Behavior Questionnaire of Busschaert et a
timeFrame: T2-assessment 3 months after therapy completion
measure: Sedentary Behavior Questionnaire of Busschaert et a
timeFrame: T3-assessment 6 months after therapy completion
measure: The Short Form Health Survey-36 items (SF-36)
timeFrame: Baseline
measure: The Short Form Health Survey-36 items (SF-36)
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: The Short Form Health Survey-36 items (SF-36)
timeFrame: T2-assessment 3 months after therapy completion
measure: The Short Form Health Survey-36 items (SF-36)
timeFrame: T3-assessment 6 months after therapy completion
measure: Fear avoidance Beliefs Questionnaire
timeFrame: Baseline
measure: Fear avoidance Beliefs Questionnaire
timeFrame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
measure: Fear avoidance Beliefs Questionnaire
timeFrame: T2-assessment 3 months after therapy completion
measure: Fear avoidance Beliefs Questionnaire
timeFrame: T3-assessment 6 months after therapy completion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
city: Rotterdam
country: Netherlands
facility: Rotterdam University of Applied Sciences
Study officials:
References: