Preliminary development of a tool allowing to predict which patients with low back pain who would best benefit from a specific exercise program
| ISRCTN | ISRCTN94152969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94152969 |
| Protocol serial number | 2010-0022 |
| Sponsor | Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) |
| Funder | Occupational Health and Safety Research Institute Robert-Sauvé (Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail) |
- Submission date
- 07/11/2016
- Registration date
- 14/11/2016
- Last edited
- 01/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Lower back pain (LBP) is a common and costly problem, which affects most people at some point in their lives. Around 70% of people suffering from LBP naturally recover within 3-4 weeks, the so-called acute phase of LBP. However, the remaining 30% (non-acute LBP) will account for most of the costs because 10% will develop long-term (chronic) disabling LBP. Physical exercise can reduce pain and disability in patients with non-acute LBP, but these effects are relatively modest on the whole. To enhance the effectiveness of this type of treatment, it is necessary to appropriately match different patient groups to different types of exercise programs, so that patients can obtain maximum benefit. The researchers intend to develop a tool that would make this match for a specific exercise program that is gaining credibility and popularity: lumbar stabilization exercises. This tool is a clinical prediction rule (CPR) that would target, during the initial clinical examination, the patients that would likely best respond to this exercise program. The overall aim of this study is to begin the development of a tool allowing clinicians, at the initial exam, to identify which patients would benefit or not benefit of a lumbar stabilization exercise program, and find out why some patients benefit more than others to this exercise program.
Who can participate?
Sixty adults with low back pain and thirty healthy people of the same age.
What does the study involve?
The 60 patients take part in an 8 week lumbar stabilization exercise program, which is led by trained physiotherapists. This involves taking part in two, 30-minute sessions per week of completing a range of exercises designed to better control and strengthen abdominal and lower back muscles. After the program ends, patients review the exercises they have learned with the physiotherapists and encouraged to continue practicing them at home. At the start of the study, half way through and at the end of the exercise program, as well as six months later, participants complete a number of questionnaires in order to assess different psychological characteristics as well as their disability and pain levels to find out how effective the treatment is. A physical exam is also performed at the start and end of the exercise program. The psychological and physical measures collected at the start of the exercise program will be used to predict who has benefited and who has not benefited from this exercise program. The measures that will show predictive value will then be retained in clinical prediction rules of treatment success and failure. Once these rules will be fully developed, they will be used by the clinicians as decision tools to help them determine if a lumbar stabilization program is likely to benefit (or not) to their patients. The 30 healthy patients are assessed twice (8 weeks apart) in a laboratory setting to evaluate the control of their trunk (torso) muscles with the use of 6 tests. The non-obese patients are also asked to perform the same laboratory assessments.
What are the possible benefits and risks of participating?
Patients may benefit from taking part in the exercise program. The risk of participating to the exercise program is minimal, although it can temporarily make low back pain feel worse. There are no direct benefits or risks to the healthy people taking part.
Where is the study run from?
The study is run from PhysioExtra and the Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (Canada)
When is the study starting and how long is it expected to run for?
July 2012 to August 2016
Who is funding the study?
Occupational Health and Safety Research Institute Robert-Sauvé (Canada)
Who is the main contact?
Dr Christian Lariviere
Contact information
Scientific
Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
505, boulevard De Maisonneuve Ouest
Montreal
H3A 3C2
Canada
| 0000-0003-4299-4755 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-randomised interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Preliminary development of a clinical prediction rule for identifying patients with non-acute low back pain who respond best to a lumbar stabilization exercise program |
| Study objectives | The overall aim of this study is to: 1. Initiate the development of a clinical prediction rule allowing clinicians, at the initial exam, to identify which patients would benefit or not benefit of a lumbar stabilization exercise program 2. Research to understand why some patients benefit more than others to this exercise program |
| Ethics approval(s) | Ethics Committee of the Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), 26/07/2012, ref: CRIR-638-0512 |
| Health condition(s) or problem(s) studied | Low-back pain |
| Intervention | All patients will take part in an 8-week lumbar stabilization exercise program, which consists of two 30 minute sessions per week, in local physiotherapy clinics without any co-intervention allowed. Physiotherapists will be involved in the preliminary identification of patients (inclusion and exclusion criteria will be strictly applied by a research assistant) and will supervise the exercise program. Patients will also be recruited through newspaper advertisements. Six to eight physiotherapists will be trained to deliver this intervention. A two-days training session will be provided by a researcher (JPD) and another expert (physical therapist) trained in this approach. They will perform their own initial clinical assessment, independently of the clinical and laboratory assessments carried out by the research assistant, to apply their clinical judgment (adjustment of the dosage of the exercise program). In order to standardize the information given to the patients about their condition the pamphlet entitled ‘’Back Book’’ will be handed out to the patients as the first visit. The patients will be encouraged to do the exercises at home. The exercise program will focus on motor control of the deep trunk muscles, followed by gradual inclusion of overloading exercises designed to improve endurance and strength of the paraspinal and abdominal muscles. During the last appointment, the physiotherapist will review the home exercise program with the patient to ensure that they know and understand the expected exercise and frequency, so that they can continue the exercises once the treatment ended at 8 weeks. Participants will be followed up at 6 months by a research assistant who will send questionnaires by mail. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Perceived disability is measured using the Oswestry disability questionnaire (OSW) at baseline, 4 weeks, 8 weeks and 6 months |
| Key secondary outcome measure(s) |
Clinical assessment: |
| Completion date | 01/08/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 62 |
| Key inclusion criteria | Patients with low-back pain: 1. Aged between 18 and 65 2. Fluency in either French or English 3. Experiencing LBP for at least four weeks, with or without leg pain 4. Scoring above 12% on the Oswestry disability questionnaire (OSW) [minimum clinically important change is 10 points] Healthy controls: 1. Aged between 18 and 65 2. Fluency in either French or English |
| Key exclusion criteria | Patients with low-back pain: 1. Specific lumbar pathology (fracture, infection or tumor) or scoliosis 2. One positive neurological sign in two test categories (knee and ankle reflexes, myotomes, dermatomes) 3. Having previously undergone back surgery 4. Systemic disease 5. Having begun an exercise program in the last six months and (6) pregnancy. Healthy controls: 1. Back pain in the preceding year or back pain exceeding one week in the years before 2. Surgery of the pelvis or spinal column 3. Systemic disease 4. Having begun an exercise program in the last three months 5. Pregnancy 6. Obesity (body mass index > 30 kg/m2) |
| Date of first enrolment | 17/10/2012 |
| Date of final enrolment | 27/06/2014 |
Locations
Countries of recruitment
- Canada
Study participating centres
Montreal
H2B 1J9
Canada
6300 avenue Darlington
Montréal
H3S 2J4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The participant level data will not be made available for this pilot study. Funding is being sought to pursue the data collection (n = 50 additional patients according to the new sample size estimation) and reach the required sample size (n = 98) to derive robust (stable) clinical prediction rules of success and failure. Then, the complete data set will be made available. All personal information collected during the study will be codified to insure confidentiality. Only the research team members will have access to that information. However, for research projects controls, the study file could be consulted by a mandated person from the ethic committee of the CRIR establishments or the Ethic Unit of the Health and Social Services ministry, which adhere to a strict confidentiality politic. The data will be kept locked in a cabinet (questionnaires and electronic files on a backup support) at the Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Institut de réadaptation Gingras-Lindsay-de-Montréal, Montréal, by the study leader. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/10/2017 | 01/12/2022 | Yes | No | |
| Basic results | 12/12/2016 | 15/12/2016 | No | No | |
| Basic results | 12/12/2016 | 15/12/2016 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN94152969_BasicResults_12Dec16.docx
- Uploaded 15/12/2016
Editorial Notes
01/12/2022: Publication reference and total final enrolment added.
15/12/2016: Results summary uploaded.