Multimodal Intervention to Improve Pain and Health in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Chronic
- Sponsor
- IBS Granada
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Low back pain is one of the most common health problems seen in the primary care. Chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). No previous study has included a multimodal supervised program in patients with NSCLBP. The primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (Intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with NSCLBP.
Investigators
Víctor Segura Jiménez
Principal Investigator
IBS Granada
Eligibility Criteria
Inclusion Criteria
- •Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al
- •Intend to participate in the intervention and perform all the tests included in the study.
- •Able to read and understand informed consent, as well as the objective of the study.
- •Able to walk and move without outside help.
- •Able to communicate without problems.
Exclusion Criteria
- •Be under 20 years or over 65 years old.
- •Having acute or terminal illness.
- •Having medical prescription that prevents the performance of the tests.
- •Having injury or circumstance that makes it impossible to perform the tests correctly.
- •Having other physical or mental illness that prevents participating in the intervention.
Outcomes
Primary Outcomes
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months
Time Frame: Change from baseline at 3.5 months (Posttest minus Pretest)
It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 2 months
Time Frame: Change from baseline at 2 months (Posttest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 3.5 months
Time Frame: Change from baseline at 3.5 months (Posttest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1
Time Frame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months
Time Frame: Change from baseline at 2 months (Posttest minus Pretest)
It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1
Time Frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 5 months
Time Frame: Change from baseline at 5 months (Posttest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
Time Frame: Change from baseline at 2 months (Posttest minus Pretest)
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Secondary Outcomes
- Change from baseline physical activity and sedentary time at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Gait parameters at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Gait parameters at 2 months control and intervention group 1(Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Fat percentage at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Disability due to pain at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Pain intensity at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Disability due to pain at 3.5 months(Change from baseline at 3.5 months (Posttest minus Pretest))
- Change from baseline Pain intensity at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Fat percentage at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Immunology at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Pain intensity at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline physical activity and sedentary time at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Gait parameters at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Fat percentage at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Health-related quality of life at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Depression severity at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Depression severity at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Haemostasis at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Hormones at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Disability due to pain at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Gait parameters at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Health-related quality of life at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Central sensitization at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Pain Catastrophyzing at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Pain Catastrophyzing at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Anxiety state at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline physical activity and sedentary time at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Depression severity at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Sleep duration and quality at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Health-related quality of life at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Central sensitization at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Pain Catastrophyzing at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Anxiety state at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Specific Proteins at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Specific Proteins at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Muscular fitness at 3.5 months control and intervention group 1: cardio-respiratory fitness(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Central sensitization at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Anxiety state at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Haemostasis at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Specific Proteins at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Hormones at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Vitamin D-25OH at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 3.5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Muscular fitness at 5 months control and intervention group 1: upper body strength(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 2 months: lower body endurance(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Sleep duration and quality at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Specific Proteins at 3.5 months(Change from baseline at 3.5 months (Posttest minus Pretest))
- Change from baseline Specific Proteins at 2 months control and intervention group 1(Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Vitamin D-25OH at 2 months(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Immunology at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 5 months control and intervention group 1: cardio-respiratory fitness(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 3.5 months: upper body strength(Change from baseline at 3.5 months (Posttest minus Pretest))
- Change from baseline Sleep duration and quality at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Haemostasis at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Hormones at 5 months control and intervention group 1(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Vitamin D-25OH at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Muscular fitness at 2 months: upper body strength(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Muscular fitness at 3.5 months: lower body endurance(Change from baseline at 3.5 months (Posttest minus Pretest))
- Change from baseline Muscular fitness at 3.5 months: The trunk muscle endurance(Change from baseline at 3.5 months (Posttest minus Pretest))
- Change from baseline Immunology at 3.5 months control and intervention group 1(Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest))
- Change from baseline Muscular fitness at 2 months: isometric and isokinetic trunk flexor and extensor endurance/strength(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Muscular fitness at 2 months: cardio-respiratory fitness(Change from baseline at 2 months (Posttest minus Pretest))
- Change from baseline Muscular fitness at 5 months: The trunk muscle endurance(Change from baseline at 5 months (Retest minus Pretest))
- Change from baseline Muscular fitness at 5 months control and intervention group 1: lower body endurance(Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest))
- Change from baseline Muscular fitness at 2 months: The trunk muscle endurance(Change from baseline at 2 months (Posttest minus Pretest))