Does home-based tilt-table inversion traction therapy reduce pain in people with chronic discogenic low back pain (LBP)?
Testing a heuristic protocol for Inversion traction treatment for people with chronic discogenic low back pain (LBP): Randomised Control Trial
Associate Professor Rachel Page
120 participants
Jun 15, 2016
Interventional
Conditions
Summary
A prominent Musculokeletal Specialist in Wellington, with many years’ experience of using inversion for LBP, has developed his own (i.e. heuristic) assessment protocol, and it is this method as well as the efficacy of tilt-table inversion therapy which are being tested in this study. This study is investigating whether the use of inversion therapy may reduce pain, and/or improve quality of life in chronic LBP patients, where it is thought that the pain is associated with the intervertebral disc (i.e. discogenic pain). In this study inversion therapy will be performed using the Teeter tilt-table. We are looking to test whether four weeks of at-home inversion therapy is beneficial for people who have had LBP for more than six months, either with or without leg symptoms, which is suspected to involve the disc (according to this heuristic assessment protocol), and which has not settled with conventional therapy.
Eligibility
Inclusion Criteria15
- Male or Female or Gender Uncertainty
- Aged between 18 - 60 years
- Height between 147 – 198 cm inclusive (height limits of tilt-table)
- Chronic LBP for greater than 6 months duration, and consistent with discogenic LBP, with or without leg pain
- LBP present on more than half the days in the past 6 months
- At least 4/10 on the NPRS as used by Dr. Kanji
- Pain aggravated by bending, lifting, sitting for long periods
- Relieved by lying down, walking around
- Radiological confirmation of disc derangement
- MRI annular tear, dehydration, narrowing (less than or equal to 80%)
- X-Ray changes of disc narrowing (less than or equal to 80%), or osteophytes
- Experience no adverse effects while undergoing a trial on the tilt-table inversion (including ability to coordinate self-treatment using this device)
- Ability (space) to accommodate the inversion table at home
- No prior experience of inversion therapy
- Proficient in English language
Exclusion Criteria23
- Systemic Inflammatory disorders usually associated with constant pain, or little change with position or lying down, (Rheumatoid arthritis, psoriatic arthritis, SLE, Ankylosing Spondylitis, etc)
- Recent fractures
- Any hip disorders or hip replacements – hip pain predicted by presence of limp and anterior medial pain hip pain on stressing with flexion / adduction
- Pain of sacro-iliac origin - patients with a positive thigh thrust test or compression test are more likely to have SI joint pain (Szadek et al., 2009) or 3 or more SIJ pain provocation tests in absence of centralisation or peripheralisation of pain (Laslett et al., 2003)
- Pregnancy
- Weight more than 140kg
- Spinal surgery
- Greater than 80% disc narrowing on X-ray or MRI scan
- Uncontrolled arterial hypertension
- Cerebrovascular accident
- Hiatus hernia
- Ventral hernia
- Glaucoma
- Detachment of retina
- Known high intraocular pressure or central retinal artery pressure
- Uncontrolled congestive heart failure
- Severe vascular disease
- Chronic obstructive & restrictive lung disorders
- Osteoporosis
- Vulnerable areas of stress from recent surgery
- History of cancer
- Psychological or physical impediment to inversion e.g. disability-wheelchair bound or
- ankle pain
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Interventions
This study is investigating whether the use of inversion therapy may reduce pain in chronic LBP patients, where it is thought that the pain is associated with the intervertebral disc (i.e. discogenic pain), According to a heuristic assessment protocol of a prominent Musculoskeletal Pain Specialist with many years experience of using Inversion therapy for LBP. In this study inversion therapy will be performed using the Teeter tilt-table. We are looking to test whether four weeks of at-home inversion therapy is beneficial for people who have had LBP for more than six months, either with or without leg symptoms, which is suspected to involve the disc, and which has not settled with conventional therapy. If participants are randomised into the inversion group (and have tolerated the inversion at the initial appointment and prior to randomisation), a tilt-table inversion machine will be delivered to their home for the four weeks of the trial. They may also continue with their usual care, as directed by the specialist. They will be expected to complete the inversion to 45 degrees, for 3 sets of 2 minutes (with 1 minute rest - in the upright position - between the 3 sets), twice (2 times) a day. So this would require 20 minutes a day. Also to encourage fidelity amongst the inversion group we will be asking them to complete a daily inversion diary. It is well accepted, with respect to LBP, that the research, the current assessment and management knowledge is lmited, consequently it is difficult to be confident in the definition and diagnosis of LBP. We are basing our assessment of likely discogenic LBP on the work of Waddell (1987, 2005), Chou et al., (2007), and Chanda et al., (2011) concerning the diagnositic triage; as well as the work of Bogduk (2009) on referred pain; and researchers who have undertaken studies to help rule out hip (Brown et al., 2004), and SIJ disorders (Laslett et al., 2003; Szadek et al., 2009). So the heuristic assessment protocol (detailed within the Inclusion and Exclusion criteria with respect to discogenic LBP) that we are testing (as well as the effect of inversion on this particular presentation of LBP) is based upon these sources. It is not 'newly developed' per se, as it is used in clinical practice but, in itself, has not been previously studied or validated;
Locations(1)
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ACTRN12616000549426