Low Back PainBack2HealthNCT06594796
A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
A study testing Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy) in people with Low Back Pain, run by Willeke Boonstra at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jan 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Vrije Universiteit Amsterdam
Amsterdam
Boonstra, 31 657315059, w.boonstra2@vu.nl
About this study
Official title: A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity: a Randomized Controlled Trial with Parallel Economic Evaluation
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.
- Conditions
- Low Back Pain
- Being tested
- Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)
- Keywords
- Low Back Pain, Lifestyle Intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)Behavioural
One of five recognized combined lifestyle interventions (BeweegKuur, CooL, SSIB, SLIMMER, X-Fittt) integrated with LBP care.
| Study group | Role | What they receive |
|---|---|---|
| Combined lifestyle intervention with LBP care | Experimental | A combined lifestyle intervention (GLI) integrated into standard care for LBP according to clinical guidelines of the Dutch physiotherapy (KNGF) and delivered by GLI certified physio/exercise therapists. A GLI aims to increase physical activity, improve diet and sleep, change health behavior, and are effective in reducing weight amongst overweight and obese adults. The intervention is tailored to the patient's lifestyle risk and clinical LBP factors using shared decision-making. Patients define their own treatment goals and remain in charge of the treatment procedures. The intervention has a duration of two years of which the first six months focus on behavioral change, the latter 18 months focus on maintenance of newly set behaviors. Participants are guided using group and individual sessions where evidence-based behavioral change techniques will be employed such as motivational interviewing, self-monitoring and action and coping planning. Receives: Behavioral: Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy) |
| Usual care | No intervention | Usual care as prescribed by the medical specialist. This can vary from a watchful waiting strategy to referral to physiotherapy, exercise therapy, or general practitioner care according to the Dutch physiotherapy (KNGF) and general practice (NHG) guidelines for LBP; e.g. education, exercise therapy and pain medication. It may also involve re-entry to the hospital after failed treatment in primary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week.
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.
Measured: Baseline, 6, 24 and 36 months. Primary outcome 36 months.
Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ).
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).
Measured: Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months.
Secondary outcomes (9)
Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS)
The NPRS is a 11-point scale consisting of integers from 0 to 10; 0 representing "no pain" and 10 represents "worst possible pain".
Measured: Baseline, 6, 12, 24 and 36 months
Weight and BMI
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).
Measured: Baseline, 6, 12, 24 and 36 months
Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI)
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.
Measured: Baseline, 6, 12, 24 and 36 months
Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ)
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.
Measured: Baseline, 6, 12, 24 and 36 months
A process evaluation will be conducted alongside the RCT with a mixed-method approach.
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.
Measured: Baseline, 6 and 24 months
Systemic inflammation (TNF-alpha, hsCRP)
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.
Measured: Baseline, 12 and 36 months
Quality of Life (QALYs)
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.
Measured: Baseline, 6, 12, 24 and 36 months
Costs will be measured using a questionnaire based on various iMTA questionnaires.
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.
Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months
Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7.
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).
Measured: 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Jan 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Willeke Boonstra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Willeke Boonstra, VU University of Amsterdam
- Investigators
- Gwendolyne Scholten-Peeters, PhD, PT, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594796
- Sponsor's protocol ID
- NL85373.028.23
- Acronym
- Back2Health
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boonstra W, van Dongen JM, Ostelo RWJG, van der Ploeg HP, Kempen DHR, van Nassau F, Schipholt IJL; Back2Health Consortium; Scholten-Peeters GGM. (Cost-)effectiveness of a combined lifestyle intervention integrated into standard care for low back pain compared to usual care for people with persistent non-specific low back pain who are overweight or obese: Protocol for a randomised controlled trial with parallel economic and process evaluations (Back2Health). Contemp Clin Trials Commun. 2026 Aug 1;53:101676. doi: 10.1016/j.conctc.2026.101676. eCollection 2026 Oct.
PubMed 42602955
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity: a Randomized Controlled Trial with Parallel Economic Evaluation
- ClinicalTrials.gov ID
- NCT06594796
- Acronym / sponsor ID
- Back2Health / NL85373.028.23
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Willeke BoonstraUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined lifestyle intervention with LBP care | Experimental | Behavioral: Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)A combined lifestyle intervention (GLI) integrated into standard care for LBP according to clinical guidelines of the Dutch physiotherapy (KNGF) and delivered by GLI certified physio/exercise therapists. A GLI aims to increase physical activity, improve diet and sleep, change health behavior, and are effective in reducing weight amongst overweight and obese adults. The intervention is tailored to the patient's lifestyle risk and clinical LBP factors using shared decision-making. Patients define their own treatment goals and remain in charge of the treatment procedures. The intervention has a duration of two years of which the first six months focus on behavioral change, the latter 18 months focus on maintenance of newly set behaviors. Participants are guided using group and individual sessions where evidence-based behavioral change techniques will be employed such as motivational interviewing, self-monitoring and action and coping planning. |
| Usual care | No intervention | –Usual care as prescribed by the medical specialist. This can vary from a watchful waiting strategy to referral to physiotherapy, exercise therapy, or general practitioner care according to the Dutch physiotherapy (KNGF) and general practice (NHG) guidelines for LBP; e.g. education, exercise therapy and pain medication. It may also involve re-entry to the hospital after failed treatment in primary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined 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. | Behavioural | Combined lifestyle intervention with LBP care |
Primary outcome
Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week.
Time frame: 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).
Time frame: 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).
9 secondary outcomes
Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 6, 12, 24 and 36 months
Weight and BMI
Time frame: Baseline, 6, 12, 24 and 36 months
Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline, 6, 12, 24 and 36 months
Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ)
Time frame: Baseline, 6, 12, 24 and 36 months
A process evaluation will be conducted alongside the RCT with a mixed-method approach.
Time frame: Baseline, 6 and 24 months
Systemic inflammation (TNF-alpha, hsCRP)
Time frame: Baseline, 12 and 36 months
Quality of Life (QALYs)
Time frame: Baseline, 6, 12, 24 and 36 months
Costs will be measured using a questionnaire based on various iMTA questionnaires.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months
Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7.
Time frame: 6, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 42602955Boonstra W, van Dongen JM, Ostelo RWJG, van der Ploeg HP, Kempen DHR, van Nassau F, Schipholt IJL; Back2Health Consortium; Scholten-Peeters GGM. (Cost-)effectiveness of a combined lifestyle intervention integrated into standard care for low back pain compared to usual care for people with persistent non-specific low back pain who are overweight or obese: Protocol for a randomised controlled trial with parallel economic and process evaluations (Back2Health). Contemp Clin Trials Commun. 2026 Aug 1;53:101676. doi: 10.1016/j.conctc.2026.101676. eCollection 2026 Oct.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwendolyne Scholten-Peeters, PhD, PT principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy) in people with Low Back Pain, run by Willeke Boonstra at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwendolyne Scholten-Peeters, PhD, PT (31 205988557, g.g.m.scholten-peeters@vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week. (time frame: Baseline, 6, 24 and 36 months. Primary outcome 36 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.