Low Back Pain
Conditions
Keywords
Low Back Pain, Lifestyle Intervention
Brief summary
Low back pain (LBP) is the leading cause of disability worldwide and is costly. Lifestyle factors, such as physical inactivity, stress, sleep, excess weight, and an unhealthy diet contribute to the burden of LBP and the associated increasing demand for care. Moreover, approximately 65% of LBP patients who visit the hospital are overweight. This group is considered a complex patient group. Of the LBP patients who visit the hospital, 74% are referred back to primary care as medical specialists cannot offer them high value care. Targeting both lifestyle factors (e.g., physical activity, sleep and stress) and clinical factors related to low back pain (e.g., muscle strength, endurance, mobility) is important in the management of this group of LBP patients to improve important outcomes (e.g., functioning, physical activity) and reduce costs. Addressing lifestyle factors may also offer additional health benefits like decreased risks of diabetes and cardiovascular diseases. The primary objective of this project is to improve the management of this complex group of LBP patients, that is, patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care, and to reduce healthcare and societal costs. The primary research question is: 'Is a combined lifestyle intervention, integrated into standard care for LBP, delivered by physio/exercise therapists effective and cost-effective in improving physical functioning and/or physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care?' It is hypothesized that the combined lifestyle intervention, integrated into standard care for LBP, is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period.
Interventions
BEHAVIORALCombined lifestyle intervention and LBP care (physiotherapy, exercise therapy)
One of five recognized combined lifestyle interventions (BeweegKuur, CooL, SSIB, SLIMMER, X-Fittt) integrated with LBP care.
Sponsors
Willeke Boonstra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with persistent (≥3 months) non-specific LBP who are referred back from the hospital to primary care * Either BMI≥30 OR BMI≥25 with at least one comorbidity (osteoarthritis, sleep apnea, risk factors for cardiovascular diseases or type 2 diabetes) * Decreased physical functioning (RMDQ ≥4 out of 24) * Average LBP intensity of ≥3 out of 10 over the past week (NPRS) * ≥18 years old
Exclusion criteria
* Specific LBP (e.g., tumor or fracture) * Back surgery in the past six months * Psychiatric diseases that could hinder participation * Pregnancy or ≤9 months postpartum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week. | Baseline, 6, 24 and 36 months. Primary outcome 36 months. | The activPAL is a small non-invasive electronic logger designed to quantify free-living daily activities. The activPAL measures physical activity and sedentary behaviour through measuring accelerations and posture of the thigh. |
| Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ). | Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months. | The RMDQ is a reliable tool to measure the impact of LBP on physical functioning. It is a 24-item self-report questionnaire about how low back pain affects functional activities. Each question is worth one point, therefore scores can range from 0 (no disability) to 24 (severe disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ) | Baseline, 6, 12, 24 and 36 months | The FFQ is an adapted version of the Dietary Instrument for Nutrition Education. It consists of 20 food items and has a reference period of one month. |
| Systemic inflammation (TNF-alpha, hsCRP) | Baseline, 12 and 36 months | Three times, one vacutainer (7ml blood) will be extracted using venipuncture and serum will be stored at -80 degrees Celcius untill all data has been collected. Serum inflammatory concentrations (TNF-alpha, hsCRP) will be measured using highly sensitive ELLA by an experience laboratory technician. The choice of inflammatory markers may change before analyses due to new insights. |
| Quality of Life (QALYs) | Baseline, 6, 12, 24 and 36 months | The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures a participants' health state across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". The participants' health states will be converted into utility values using the Dutch tariff, after which Quality Adjusted Life Years (QALYs) will be calculated by multiplying the participants spent in a certain health state by the respective utility value (45). In addition, each subject will rate their own perceived health status on a visual analogue scale (VAS) of 0 to 100. |
| Costs will be measured using a questionnaire based on various iMTA questionnaires. | Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months | Costs will be measured from a societal and a healthcare perspective. From the societal perspective, costs will include the cost of the intervention, other healthcare use (i.e., primary, secondary, and medication), informal care, sports memberships and equipment, as well as the cost of productivity losses from paid (i.e. absenteeism and presenteeism) and unpaid work. From the healthcare perspective, only costs accruing to the formal Dutch healthcare sector will be included. Intervention costs will be micro-costed, meaning that detailed data will be collected regarding the number of resources used and their respective unit prices. For this, data will be gathered from questionnaires filled in by participating physio/exercise therapists. Information on all other kinds of resource use will be collected using cost questionnaires. These questionnaires are based on the various iMTA questionnaires but tailored to the specific patient population and intervention under study. |
| Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7. | 6, 12, 24 and 36 months | Each point on the scale indicates a different level of improvement; 1 representing very much improved, 2 representing much improved, 3 representing minimally improved, 4 representing no change, 5 representing minimally worse, 6 representing much worse and 7 represent very much worse. Participants will be asked to rate their overall status since the start of the study. The participants' responses to the GPE will be dichotomized into Recovered (1 and 2), and Not Recovered (3, 4, 5, 6, and 7). |
| Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS) | Baseline, 6, 12, 24 and 36 months | The NPRS is a 11-point scale consisting of integers from 0 to 10; 0 representing no pain and 10 represents worst possible pain. |
| Weight and BMI | Baseline, 6, 12, 24 and 36 months | Weight will be objectively measured via a standardized procedure using the same scale throughout the study. Weight status will be classified using Body Mass Index by dividing body weight (kg) by height (m²). |
| Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI) | Baseline, 6, 12, 24 and 36 months | The PSQI consists of 19 items that cover seven dimensions, including subjective sleep quality, sleep duration and latency (time it takes to fall asleep), and the frequency and severity of specific sleep-related complaints in the previous month. Scores from each dimension (range: 0-3) are summed to derive a sleep quality score, higher scores indicate worse sleep quality. |
| A process evaluation will be conducted alongside the RCT with a mixed-method approach. | Baseline, 6 and 24 months | The process evaluation will study the implementation and mechanism of impact of the intervention. Both participants and physio/exercise therapists will be asked to fill in questionnaires at baseline, 6 and 24 months. A selection of participants will be invited to join a focus group and a selection of physio/exercise therapists will be invited for a semi-structured interview about their experiences during the intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Socio-economic status | Baseline | Education will be considered as a fundamental indicator of socioeconomic status. |
| Pain beliefs will be assessed using the Brief Illness Perception Questionnaire (B-IPQ) | Baseline | The B-IPQ is a tool used to evaluate cognitive and emotional representations of illness. It is an 8-item questionnaire where each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. Total score can be between 0 and 80, higher scores indicate worse illness perception. Cut-off points for the B-IPQ total score as follows: \<42 indicating low experienced threat, 42-49 indicating moderate experienced threat, and ≥50 indicating high experienced threat in patients. |
| Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ) | Baseline | The PSEQ is developed to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentations. The questionnaire consists of 10 questions scored between 0 (no confidence) and 6 (full confidence). Total score can be between 0 and 60, where a higher score indicates greater levels of confidence in dealing with pain. |
| Kinesiophobia will be assessed using the Tampa scale for kinesiophobia | Baseline | The Tampa scale for kinesiophobia is a 17-item questionnaire which are scored between 1 (low fear of movement) and 4 (high fear of movement). Total score can be between 17 and 68. A score ≤37 is interpreted as absence of fear of movement, a score of \>37 is interpreted as fear of movement. |
Countries
Netherlands
Contacts
Primary ContactGwendolyne Scholten-Peeters, PhD, PT
Outcome results
None listed