None listed
Conditions
Brief summary
A variety of different treatments have been found to have similar levels of effectiveness for chronic low back pain (CLBP). Addressing postural abnormalities in both the lower back and the feet in the subpopulation of CLBP cases that also suffer from an un-level back due to fall of the arch in the foot on one side (FSL-UFHP) may prove to be a more effective treatment combination. Through this trial we take the first step in investigating this possibility. Methods: One hundred and thirty-eight adults with CLBP and FSL-UFHP to be recruited in Melbourne Australia and Madrid and Seville Spain. Forty six participants at each site to be randomized to: a) multimodal chiropractic treatment including spinal manipulation, or b) multimodal chiropractic treatment together with custom-made foot orthoses. Chiropractic visits to comprise of 12 treatments over 4 weeks. Outcome measures to include recruitment, CLBP-related disability (RMQ) and perceived LBP (NRS-11). Combining multimodal chiropractic treatment with orthoses to correct a functional short leg due to a fallen foot arch may be a promising therapeutic strategy in this subpopulation of CLBP patients, hence deserving rigorous methods of scientific investigation.
Interventions
Multimodal chiropractic treatment provided by a chiropractor, of at least 3 years' clinical experience, comprising of any combination of the following: lumbar and thoracic manipulation (such as diversified or Thompson drop-piece maneuvers), mobilization, massage, application of heat to the spine and prescription of stretching or strengthening (isometric and/or isotonic) exercise to be performed at home. The exact choice of chiropractic treatment combination as well as the intensity and duration
Multimodal chiropractic treatment provided by a chiropractor, of at least 3 years' clinical experience, comprising of any combination of the following: lumbar and thoracic manipulation (such as diversified or Thompson drop-piece maneuvers), mobilization, massage, application of heat to the spine and prescription of stretching or strengthening (isometric and/or isotonic) exercise to be performed at home. The exact choice of chiropractic treatment combination as well as the intensity and duration of any exercises that may be prescribed will depend on the clinical judgement of the chiropractic clinician. Treatment will take 4 weeks of three sessions per week. The above chiropractic treatment will be provided PLUS Podiatric treatment comprising of: custom-made orthotic treatment, as fabricated and fitted by a qualified podiatrist for 4 weeks. (briefly, a mould will be made of both of the participants' feet and used to construct custom-made orthoses to be worn as insoles). The participants will be instructed to use the orthoses in every pair of shoes that they wear during the day (with the exception of flip-flops). The podiatric treatment will be provided by a podiatrist of at least 3 years' clinical experience. Treatments will be administered one-on-one at the chiropractic or the podiatric clinic. Those receiving the combined chiropractic and podiatric treatment will be asked at every chiropractic visit to report for how many days they had worn the orthotics in the previous week.
Sponsors
Dr Michael Azari
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Non-specific low back pain of at least three-months duration; Unilateral foot hyperpronation of +6 score on Foot Posture Index (FPI); and dorsiflexion of the ipsilateral ankle of less than 10 degrees. Radiographic examination of the relative heights of the femoral heads at baseline in standard lumbopelvic views will need to demonstrate that the shorter leg is ipsilateral to the hyper-pronated foot.
Exclusion criteria
specific pathologies that may cause back pain such as internal organ disease, active inflammatory spondylo-arthropathies osteomyelitis and spinal tumours; recent spinal trauma or surgery; detection of a shorter leg contralateral to unilateral foot hyperpronation; lumbar spinal manipulation in the previous six months; radicular leg pain; diagnosed foot pathology (other than functional hyper-pronation) including trauma structural deformities or +6 score (or above) on FPI in both feet; and any previous fitting or use of orthotics.
Outcome results
None listed