No registrations found.
ID
Source
Brief title
Health condition
Low back pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
This ambitious pan European project would provide the necessary data to fill the gap in knowledge on older people with low-back pain and improve standards of chiropractic care for this patient population.
1. Examine the duration, severity, and clinical course of low-back pain in older people who visit a chiropractor for a new episode of low-back pain;
2. Identify prognostic factors which may influence this course;
3. Determine effects (e.g. functional disability, quality of life) as well as associated costs and safety of care in older people visiting the chiropractor for low-back pain.
Secondary outcome
Identify barriers and facilitators which can influence access to chiropractic care.
Background summary
Background. Low-back pain is the most important non-fatal disease in Europe and is associated with increasing healthcare costs. These costs are likely to become greater as the population becomes older. Low-back pain, particularly in older people, results in reduced quality of life, reduced social participation and increased isolation, as well as being associated with comorbidities. One conservative treatment for the treatment of low-back pain which is safe and effective is spinal manipulative therapy. In contrast to their younger counterparts, relatively little investigation has been conducted amongst older people with low-back pain in a chiropractic setting. Aim. This study would provide the necessary knowledge to improve our understanding for this patient population in order to provide safer and more effective care.
Study design and population. A prospective, multi-center practice-based cohort study will be used to collect data from older patients (>55 years of age) with low-back pain who visit a chiropractor with a new episode of low-back pain. Participants are to be recruited from the private practices of chiropractors in The Netherlands, Sweden, and the UK. Treatment will be left to the discretion of the chiropractor. The goal is to recruit at least 1,000 subjects. Outcome measures. The following primary outcomes are to be measured using self-report, validated questionnaires: 1) pain intensity (11-point VAS), 2) low-back pain-specific functional status (Oswestry Disability Index), 3) self-perceived recovery (7-point Likert scale), and 4) EQ5D-5L. Follow-up is to be conducted at the end of the second visit, and at 6 weeks and at 3, 6, 9 and 12 months. Implications of this project. This project is modelled after the BACE study (BAck Complaints in Elders), which is currently being conducted in primary care in The Netherlands, Australia and Brazil. BACE is supported by an international consortium consisting of world-leaders in research of low-back pain. Aligning ourselves with this consortium represents a unique chance for chiropractic.
Study objective
observational metrics
Study design
Patient inclusion May 2018 - May 2020, Analysis and paper submission Jan 2020 -July 2021
Intervention
chiropractic care
Inclusion criteria
Patients aged >55 years will be included when they consult a chiropractor for a new episode of low-back pain. All low-back complaints will be included, defined here as pain extending from the thoracolumbar junction to the first sacral vertebra and extending to the pelvis. An episode is considered new if the patient has not visited a chiropractor during the preceding six months for the same back complaint.
Exclusion criteria
Subjects who are unable to complete the web-based questionnaires because of language restrictions or computer literacy restrictions will be excluded as well as those with cognitive disorders. In addition, those with a suspected tumor, fracture, infection or any other potential red flag or condition considered to be a contraindication for spinal manipulative therapy will be excluded.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7507 |
| Other | European Centre for Chiropractic Research Excellence, Nederlandse Chiropractie Associatie : METC2017618 |