Costs and effectiveness of chiropractic care and physiotherapy in the treatment of chronic low back pain
| ISRCTN | ISRCTN15830360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15830360 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/02/2017
- Registration date
- 20/02/2017
- Last edited
- 26/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Tomtebodavägen 18A
Stockholm
SE-17177
Sweden
 ORCID ID |
0000-0003-4036-6966 |
|---|
Study information
| Study design | Multicentre pragmatic open randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Regionala etikprövningsnämnden, Stockholm (the regional ethics board in Stockholm), 21/11/2016, ref: 2016/1318-31-31 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/03/2015 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 95 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/02/2017 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centres
136 25
Sweden
134 40
Sweden
172 66
Sweden
183 34
Sweden
131 45
Sweden
186 36
Sweden
184 35
Sweden
Sponsor information
University/education
Tomtebodavägen 18A
Stockholm
SE-17177
Sweden
| Website | http://ki.se/mmc |
|---|---|
"ROR" |
https://ror.org/04hmgwg30 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/12/2017 | Yes | No | |
| Results article | 25/02/2025 | 26/02/2025 | Yes | No |
Editorial Notes
26/02/2025: Publication reference added.
13/01/2020: The final enrolment number has been added.
15/02/2018: Publication reference added.
22/12/2017: The following changes were made:
1. The recruitment end date was changed from 25/02/2018 to 31/12/2019.
2. The overall trial end date has been changed from 13/02/2020 to 31/12/2020.
3. Participant exclusion criteria and trial participating centres were updated.
