Condition category
Musculoskeletal Diseases
Date applied
16/02/2017
Date assigned
20/02/2017
Last edited
15/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

http://ki.se/mmc

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

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29273083

Publication citations

Additional files

Editorial Notes

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.