RecruitingACTRN12616000549426

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


Sponsor

Associate Professor Rachel Page

Enrollment

120 participants

Start Date

Jun 15, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a tilt-table inversion device at home — where you lie on an angled table that tilts your body upside down — can reduce pain for people with chronic low back pain (lasting more than 6 months) that is thought to be coming from the discs in the spine. Participants will use the device at home for four weeks. The study uses a specific assessment method developed by a musculoskeletal specialist to identify patients most likely to benefit from this therapy. You may be eligible if: - You are aged 18 to 60 years - You have had low back pain for more than 6 months - Your pain is thought to come from the spinal disc (discogenic pain), with or without leg symptoms - You have imaging (MRI or X-ray) confirming disc changes - Your pain is at least 4/10 in severity and is worse with bending and sitting - You have no prior experience with inversion therapy - You have enough space at home for an inversion table You may NOT be eligible if: - You have had previous spinal surgery - You are pregnant - You weigh more than 140 kg - You have glaucoma, a hernia, uncontrolled high blood pressure, or heart failure - You have osteoporosis, a recent fracture, or cancer history - You have significant disc narrowing greater than 80% Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Wellington, New Zealand

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ACTRN12616000549426