Plain English Summary
Background and study aims
Chronic low back pain (CLBP) is a global public health problem and a leading cause of disability all over the world. Besides its severe negative impact on health and quality of life, there are substantial societal costs within and outside the healthcare system. Both medical costs for the treatment and management of CLBP and costs for production losses due to absenteeism from work are sizable. Many different treatment options are available for CLBP and both drug and non-drug treatments like physical activity, manipulation and multidisciplinary rehabilitation interventions are widely used. However, the evidence to recommend the use of one treatment over another one is limited and therefore more research is needed to study the effects and cost-effectiveness of treatments for CLBP. The aim of this study is to assess the effects (functional limitation, pain intensity, health, health-related quality of life and working status), costs (medical costs and costs for production losses) and cost-effectiveness of chiropractic care and physiotherapy when added to information and advice for patients with CLBP in Sweden.
Who can participate?
Patients aged 18 to 60 with low back pain for at least 3 months
What does the study involve?
Participants are randomly allocated to one of four groups. In the first group participants are given oral and written information in a booklet on how to manage CLBP and advice about the importance of staying active and avoiding rest. Information and advice is given to all participants in the study (i.e. participants allocated to the other treatment groups are all given information and advice). In the second group participants are treated with physiotherapy, which involves training and exercise, and the duration, number and content of treatment is at the discretion of the physiotherapist. In the third group participants are treated with chiropractic care, which involves spinal manipulation, and the duration, number and content of treatment are at the discretion of the chiropractor. In the fourth group participants are treated with both chiropractic care and physiotherapy, which involves a combination of spinal manipulation, training and exercise, and the duration, number and content of treatment sessions are at the discretion of the chiropractor and physiotherapist who jointly make a treatment plan with the participant. A web-based questionnaire is used to collect data at the start of the study and after 12, 26 and 52 weeks. Data collected include functional limitation, back pain intensity, general health, health-related quality-of-life, working status, direct costs (costs for pharmaceuticals, healthcare visits, clinical examinations, and hospital stay) and indirect costs (costs of changes in productivity).
What are the possible benefits and risks of participating?
The results from the study will increase knowledge of the effects, costs and cost-effectiveness of chiropractic care and physiotherapy for CLBP, which will improve clinical decision making. Potential risks of participating in the study are likely to be small, but minor pain and discomfort is usual after chiropractic care and physiotherapy. These mild symptoms should disappear after about 3 days.
Where is the study run from?
1. Haninge Rehab, Handens vårdcentral (Sweden)
2. Värmdö Rehab, Gustavsbergs vårdcentral (Sweden)
3. Sundbybergskliniken Primärvårdsrehab (Sweden)
4. Måbra hälsa Orminge (Sweden)
5. Måbra hälsa Saltsjöbaden (Sweden)
6. Rehab Nordost Täby (Sweden)
7. Nacka Rehabcentrum (Sweden)
When is the study starting and how long is it expected to run for?
March 2015 to December 2020
Who is funding the study?
1. Karolinska Institutet (Sweden)
2. Scandinavian of College of Chiropractic (Skandinaviska Kiropraktorhögskolan) (Sweden)
Who is the main contact?
Dr Niklas Zethraeus
Trial website
Contact information
Type
Scientific
Primary contact
Dr Niklas Zethraeus
ORCID ID
http://orcid.org/0000-0003-4036-6966
Contact details
Tomtebodavägen 18A
Stockholm
SE-17177
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Costs and effectiveness of chiropractic care and physiotherapy, compared with information and advice in the treatment of non-specific chronic low back pain: a pragmatic randomized study
Acronym
Study hypothesis
Research questions:
1. Do chiropractic care and physiotherapy, chiropractic care, or physiotherapy improve outcomes (back pain-related functional limitation, back pain intensity, general health, health-related quality of life, and working status) when added to information and advice?
2. What are the effectiveness (quality adjusted life years) and costs (medical costs and costs for production losses) of chiropractic care and physiotherapy, chiropractic care, and physiotherapy, when added to information and advice?
3. From a societal perspective, which (if any) of chiropractic care and physiotherapy, chiropractic care, or physiotherapy is a cost-effective treatment strategy compared with information and advice?
Ethics approval
Regionala etikprövningsnämnden, Stockholm (the regional ethics board in Stockholm), 21/11/2016, ref: 2016/1318-31-31
Study design
Multicentre pragmatic open randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Non-specific chronic low back pain
Intervention
Participants are randomised to one of four treatment groups:
1. Information and advice: Participants are given oral and written information in a booklet on how to manage non-specific chronic low back pain (CLBP) and advice about the importance of staying active and avoiding rest. Information and advice is given to all participants in the study (i.e. also participants allocated to the other treatment groups are given information and advice).
2. Physiotherapy: The treatment primarily involves training and exercise. The duration, number and content of treatment is at the discretion of the physiotherapist.
3. Chiropractic care: The treatment primarily involves spinal manipulation. The duration, number and content of treatment are at the discretion of the chiropractor.
4. Chiropractic care and physiotherapy: The treatment primarily involves a combination of spinal manipulation and training and exercise. The duration, number and content of treatment sessions are at the discretion of the chiropractor and physiotherapist who jointly with the patient make a treatment plan.
A computer generated block randomisation list will be produced to allocate participants to the treatment groups. The sequence will be concealed from the researchers involved in enrolling and assessing participants by using sequentially numbered, opaque, and sealed envelopes.
A patient self-reported web-based questionnaire is used to collect data on the outcome measures at baseline, 12, 26 and 52 weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Back pain-related functional limitation, measured using the Oswestry Disability Index (ODI) at baseline, 12, 26 and 52 weeks after baseline. The 26-week outcome measure is used as the primary endpoint and all other time-points are defined as secondary.
Secondary outcome measures
1. Back pain intensity, measured using the Numeric Rating Scale (NRS)
2. General health, measured using a self-rated health (SRH) question
3. Health-related quality-of-life, measured using the EQ-5D
4. Working status, defined as the percentage of full time work
Measured at baseline, 12, 26 and 52 weeks
Exploratory outcomes:
1. Costs: Direct (costs for pharmaceuticals, health care visits, clinical examinations, and hospital stay) and indirect costs (costs of changes in productivity) estimated during 12 months after randomization. The resource quantities collected at baseline, 12, 26 and 52 weeks after baseline
2. Effectiveness: Quality adjusted life years (QALYs) during 12 months after baseline, estimated using the quality of life weights based on EQ-5D (measured at baseline, 12, 26 and 52 weeks after baseline)
Overall trial start date
10/03/2015
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study includes individuals willing to participate in any of the included treatment groups; either in chiropractic care and physiotherapy, chiropractic care, physiotherapy or information and advice. The inclusion criteria are:
1. Pain below located costal margin and above the inferior gluteal folds
2. Reoccurring low back pain for at least 3 months
3. Age between 18 to 60 years
4. Can stand or walk independently
5. Swedish speaking and literate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
Current participant exclusion criteria (as of 22/12/2017):
1. Pain attributable to a known specific pathology
2. Lack of written informed consent
3. Pregnancy or less than 6 months postpartum or post weaning
4. Had any of the treatments defined in the chiropractic care and physiotherapy in the previous 1 month
5. Not showing up at baseline after randomisation
Previous participant exclusion criteria:
1. Pain attributable to a known specific pathology
2. Lack of written informed consent
3. Patient planning for surgery for low back pain during the study period or had surgery 3 month before
4. Pregnancy or less than 6 months postpartum or post weaning
5. Had any of the treatments defined in the chiropractic care and physiotherapy in the previous 1 month
6. Not showing up at baseline after randomisation
Recruitment start date
27/02/2017
Recruitment end date
31/12/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Haninge Rehab, Handens vårdcentral
Stockholm
136 25
Sweden
Trial participating centre
Värmdö Rehab, Gustavsbergs vårdcentral
Stockholm
134 40
Sweden
Trial participating centre
Sundbybergskliniken Primärvårdsrehab
Stockholm
172 66
Sweden
Trial participating centre
Rehab Nordost Täby
Stockholm
183 34
Sweden
Trial participating centre
Nacka Rehabcentrum
Stockholm
131 45
Sweden
Trial participating centre
Vallentuna Rehab
Stockholm
186 36
Sweden
Trial participating centre
AktivaRe Åkersberga Rehab
Stockholm
184 35
Sweden
Sponsor information
Organisation
Karolinska Institutet
Sponsor details
Tomtebodavägen 18A
Stockholm
SE-17177
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Karolinska Institutet
Alternative name(s)
Karolinska Institute, KI
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Funder name
Scandinavian College of Chiropractics (Skandinaviska Kiropraktorhögskolan) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The plan is to publish in high impact peer review journals.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Filip Gedin (Filip.Gedin@ki.se).
Intention to publish date
31/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29273083