None listed
Conditions
Brief summary
This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan. The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.
Interventions
Osteopathic Healthcare involves:
One on one face to face 45 minute consultations, once a week for 4 weeks, applied by university masters osteopathy student under registered osteopath supervision, described fully on case form.
Manual Therapy
Practitioner to choose from a mixture of the following, depending on patient presentation, tissue state and patient preferences: soft tissue/myofascial techniques, muscle energy/stretching, articulation, high velocity low amplitude manipulation, indirect/posi
Osteopathic Healthcare involves: One on one face to face 45 minute consultations, once a week for 4 weeks, applied by university masters osteopathy student under registered osteopath supervision, described fully on case form. Manual Therapy Practitioner to choose from a mixture of the following, depending on patient presentation, tissue state and patient preferences: soft tissue/myofascial techniques, muscle energy/stretching, articulation, high velocity low amplitude manipulation, indirect/positional release, craniosacral. Education Practitioner describe to participant within the 45 minute consultation what was found and how this relates to their pain and function. An outline of current understanding of chronic pain is given, a description of the participants likely pain mechanism (whether peripheral or central or combination), and reassurance about the prognosis of chronic low back pain. Advice Participant is given regarding specific rehabilitative exercises that will address the specific osteopathic diagnosis (stretching, strengthening, balance and coordination), as well as postural and ergonomic advice if required.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Low back pain (between lower ribs to buttocks) History of LBP longer than 3 months Average severity ranked between 3-7 on Visual Analogue Scale Absence of diagnosis of pathology causing pain (malignancy, inflammatory disease, IV disc prolapse, fracture/trauma) Proficiency in English language
Exclusion criteria
Confirmed pathological cause of LBP, Acute or subacute pain (less than 12 weeks), Severe pain limiting ambulation and/or exercise (ie above average 7 on VAS), Co-morbidities that contraindicate manual therapy (list from intake form), Post-surgical patients, Moderate to severe depression based on the Patient Health Questionnaire (PHQ-9) Insurance claims (workers compensation or concurrent litigation)
Outcome results
None listed