None listed
Conditions
Brief summary
The principal aim of this study is to investigate how three different types of lower back spinal manipulation—specifically targeted manipulation, non-targeted (general) manipulation, and a sham (placebo) manipulation—affect people with chronic low back pain (CLBP). This study will compare how these three types of manipulation impact pain, function, and range of motion in the immediate, short-term and medium-term. Ultimately, the goal of this study is to determine whether targeting specific areas of the lower back with manipulation leads to better outcomes than general manipulation, and whether both approaches are more effective than a sham manipulation. The working hypothesis is that a specific manipulation will lead to better outcomes, but one can never be sure. This study will contribute new knowledge by providing a clearer understanding of whether targeting specific areas of the lumbar spine with manipulation is more effective than a general, non-specific manipulation for treating CLBP. By combining clinical outcomes (such as pain relief and range of motion) with physiological markers of pain (substance P), we will gain insights into how these treatments work on both a clinical and physiological level. The results will provide insights into the most effective manipulation techniques, which will help clinicians understand the effects of different types of manipulation on clinical and physiological outcomes of pain. This could ultimately enhance clinical practice, making treatments more efficient and targeted, and potentially reduce the long-term disability associated with CLBP, leading to better overall health outcomes for patients.
Interventions
Arm 1: Specific lumbar spine high velocity thrust: Thrust applied to the specific symptomatic/stiff segment (i.e. L4-5) determined by the objective examination.
Arm 2: Non-specific lumbar spine high velocity thrust: Thrust applied to the whole lumbar spine i.e. L5-L1.
Arm 3: Sham lumbar spine high velocity thrust: Non-specific lumbar spine stretch with no thrust applied to the whole lumbar spine i.e. L5-L1. This is exactly the same as Arm 2 (Non-specific lumbar spine high velocity thrust) minu
Arm 1: Specific lumbar spine high velocity thrust: Thrust applied to the specific symptomatic/stiff segment (i.e. L4-5) determined by the objective examination. Arm 2: Non-specific lumbar spine high velocity thrust: Thrust applied to the whole lumbar spine i.e. L5-L1. Arm 3: Sham lumbar spine high velocity thrust: Non-specific lumbar spine stretch with no thrust applied to the whole lumbar spine i.e. L5-L1. This is exactly the same as Arm 2 (Non-specific lumbar spine high velocity thrust) minus the thrust. Each participant will receive four fully funded, face-to-face, physiotherapy sessions from weeks one to four, receiving either the specific high-velocity thrust, non-specific high-velocity thrust, and sham high-velocity thrust by the same treating physiotherapist. The initial session will be two-hours followed by three one-hour follow-up sessions over a four-week period. The frequency over this four week period will be at the discretion of the treating physiotherapist and the participant, mimicking normal clinical practice. The only criterion is that the participant receives four physiotherapy sessions over the four week period. The same therapist will perform all interventions for the same participant, but there will be multiple therapists involved in the trial. Notes will be written following each intervention session. Although not formally assessed, this will help monitor adherence. Appropriate training for each therapist will occur to ensure they are competent to perform the intervention and standardisation of assessment/treatment/data collection. Interventions will be conducted through the School of Physiotherapy clinics, University of Otago and Consultancy House. Both being in Dunedin. For standardization, the clinicians performing the interventions will receive a single, fac-to-face two-hour training session lead by the lead investigator (who currently teaches these manipulation techniques to undergraduate and postgraduate physiotherapy students) in how to perform the specific high-velocity thrust, non-specific high-velocity thrust, and sham high-velocity thrust applied in each arm of the trial. This training session will be held at least a month before commencement of the intervention.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
All individuals aged between 18 and 65 with chronic low back pain (CLBP) will be included. CLBP is defined as pain every day for three months or pain for at least half the days in the last six months
Exclusion criteria
Individuals with any contraindications to lumbar spine manipulation (such as osteoporosis, fractures, active inflammatory or infectious disorders), red flags (such unremitting night pain or a non-mechanical presentation), neurological compromise (such as a radiculopathy), previous history of lumbar spine surgery, or current pregnancy will be excluded. Individuals with any precautions to lumbar spine manipulation (such as connective tissue disorders) or general medical conditions will be assessed on a case-by-case basis.
Outcome results
None listed