Weight Reduction in CLBP

Chronic Low-back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824248
• Other study ID #: B.U.N. 1432021000411
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Vrije Universiteit Brussel
• Contact: Anneleen Malfliet, PhD
• Phone: 003224774503
• Email: anneleen.malfliet[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 online and will be a combination of online education material and face-to-face video calls 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Overweight
• Overweight or Obesity
• Weight Loss

Intervention

Behavioral:
• Pain Neuroscience Education
Increase pain coping skills and educating the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms.
• Cognition-targeted exercise therapy
Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.
• Behavioral weight reduction program
Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	Change from baseline to 6 months (T3) after therapy completion
Primary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	Difference between groups at 6 months (T3) after therapy completion
Secondary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	Baseline assessment (T0)
Secondary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Secondary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	T2-assessment 3 months after therapy completion
Secondary	Brief Pain inventory (BPI)	Questionnaire for assessing clinical pain	T3-assessment 6 months after therapy completion
Secondary	Central sensitization inventory (CSI)	Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.	Baseline Assessment (T0)
Secondary	Central sensitization inventory (CSI)	Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	Central sensitization inventory (CSI)	Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.	T2-assessment 3 months after therapy completion
Secondary	Central sensitization inventory (CSI)	Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.	T3-assessment 6 months after therapy completion
Secondary	TANITA Bio-electrical Impedance Analyzer	Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)	Baseline assessment (T0)
Secondary	TANITA Bio-electrical Impedance Analyzer	Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	TANITA Bio-electrical Impedance Analyzer	Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)	T3-assessment 6 months after therapy completion
Secondary	SECA wall-fixed SECA wall-fixed stadiometer	Body height measurement used to calculate BMI (= weight[kg] / height[m]²)	Baseline measurement
Secondary	SECA wall-fixed SECA wall-fixed stadiometer	Body height measurement used to calculate BMI (= weight[kg] / height[m]²)	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	SECA wall-fixed SECA wall-fixed stadiometer	Body height measurement used to calculate BMI (= weight[kg] / height[m]²)	T3-assessment 6 months after therapy completion
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat	Body composition measurement - body fat	Baseline
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat	Body composition measurement - body fat	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat	Body composition measurement - body fat	T3-assessment 6 months after therapy completion
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass	Body composition measurement - fat free mass	Baseline
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass	Body composition measurement - fat free mass	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass	Body composition measurement - fat free mass	T3-assessment 6 months after therapy completion
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status	Body composition measurement - hydration status	Baseline
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status	Body composition measurement - hydration status	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status	Body composition measurement - hydration status	T3-assessment 6 months after therapy completion
Secondary	Food Frequency Questionnaire	Self report questionnaire to asses dietary intake	Baseline
Secondary	Food Frequency Questionnaire	Self report questionnaire to asses dietary intake	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	Food Frequency Questionnaire	Self report questionnaire to asses dietary intake	T2-assessment 3 months after therapy completion
Secondary	Food Frequency Questionnaire	Self report questionnaire to asses dietary intake	T3-assessment 6 months after therapy completion
Secondary	International Physical Activity Questionnaire (IPAQ)	Self report questionnaire to asses physical activity	Baseline
Secondary	International Physical Activity Questionnaire (IPAQ)	Self report questionnaire to asses physical activity	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	International Physical Activity Questionnaire (IPAQ)	Self report questionnaire to asses physical activity	T2-assessment 3 months after therapy completion
Secondary	International Physical Activity Questionnaire (IPAQ)	Self report questionnaire to asses physical activity	T3-assessment 6 months after therapy completion
Secondary	Sedentary Behavior Questionnaire of Busschaert et a	Self report questionnaire to asses sedentary behavior	Baseline
Secondary	Sedentary Behavior Questionnaire of Busschaert et a	Self report questionnaire to asses sedentary behavior	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	Sedentary Behavior Questionnaire of Busschaert et a	Self report questionnaire to asses sedentary behavior	T2-assessment 3 months after therapy completion
Secondary	Sedentary Behavior Questionnaire of Busschaert et a	Self report questionnaire to asses sedentary behavior	T3-assessment 6 months after therapy completion
Secondary	The Short Form Health Survey-36 items (SF-36)	Self report questionnaire to evaluate functional status and well-being or quality of life	Baseline
Secondary	The Short Form Health Survey-36 items (SF-36)	Self report questionnaire to evaluate functional status and well-being or quality of life	T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Secondary	The Short Form Health Survey-36 items (SF-36)	Self report questionnaire to evaluate functional status and well-being or quality of life	T2-assessment 3 months after therapy completion
Secondary	The Short Form Health Survey-36 items (SF-36)	Self report questionnaire to evaluate functional status and well-being or quality of life	T3-assessment 6 months after therapy completion