None listed
Conditions
Brief summary
The study will be a prospective, randomised placebo controlled 3x6x3 cross over trial that will examine the effect of an isometric wall squat on pain sensitivity and clinical pain intensity when compared to a true control (quiet rest) in 30 individuals with non-specific chronic low back pain. Participants will receive each of the three interventions over a period of three weeks. The sequence of intervention exposure will be randomized according to the Williams randomised allocation sequence. This study will also evaluate the suitability of a novel placebo exercise intervention for maintaining participant blinding of intervention allocation. The hypothesis is that the isometric exercise intervention will lead to reduced pain sensitivity (exercise induced hypoalgesia) and reduced low back pain intensity when compared to the control group. A total of 4 individuals have been screened as potentially eligible. As of 09/01/2023, 3 participants have been enrolled. It is anticipated that data collection for the first participant will commence on the 16/01/2023.
Interventions
Participants will randomly receive each of the three interventions once per week over a period of three weeks with the intervention sequence for each intervention randomized electronically. The interventions will be delivered to each participant individually, face-to-face by a research assistant, who is a Master of Clinical Exercise Physiology student with experience in delivering exercise interventions to individuals with chronic pain. The interventions will be delivered indoors at the Deakin U
Participants will randomly receive each of the three interventions once per week over a period of three weeks with the intervention sequence for each intervention randomized electronically. The interventions will be delivered to each participant individually, face-to-face by a research assistant, who is a Master of Clinical Exercise Physiology student with experience in delivering exercise interventions to individuals with chronic pain. The interventions will be delivered indoors at the Deakin University Clinical Research Facility. There will be a washout period of 7 days between interventions. The three interventions consist of: A) Isometric wall squat (true intervention) Participants will perform a single repetition of an isometric wall squat, held at 100 degrees knee flexion for four minutes or until volitional fatigue. Knee flexion will be measured by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm will be in line with the lateral malleolus. Participants will be instructed to place hands across chest, their back flat against the wall and position their feet parallel to each other and spaced shoulder width apart for the exercise position. The team member delivering the intervention will monitor the time under contraction with a stopwatch. Instructions will be standardized for each participant and a neutral language script will be used to control for expectation bias. B) Multiple repetition wall squat (placebo) The placebo exercise will consist of multiple repetitions of an isometric wall squat held for 5 seconds at a knee joint angle of 100 and then 120 degrees, repeated 3 times each with a 30 second rest in standing between repetitions. Knee flexion will be measured by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm will be in line with the lateral malleolus. Participants will be instructed to place hands across chest, their back flat against the wall and position their feet parallel to each other and spaced shoulder width apart for the exercise position. Participants will firstly perform the exercise at 100 degrees of knee flexion for 3 X 5 second repetitions with 30 seconds of rest in between. Then participants will perform a further 3 X 5 second repetition with 30 seconds of rest in between at 120 degrees of knee flexion. This intensity and volume of exercise is well below the threshold expected to produce exercise induced hypoalgesia based on existing literature in pain-free and chronic pain populations. The team member delivering the intervention will monitor exercise time with a stopwatch. Instructions will be standardised for each participant and a neutral language script will be used to control for expectation bias and maintain blinding of participants to the true intervention. C) Quiet rest (control) Participants will remain seated in a chair for 4 minutes. Participants will be instructed to rest quietly in a chair. Participants will be instructed to refrain from using any technological devices including mobile phones and computers for the duration of quiet rest. The team member delivering the intervention will monitor the time with a stopwatch. Instructions will be standardized for each participant and a neutral language script will be used to reduce expectation bias.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Eligible participants will consist of adults aged 18-55 years with non-specific chronic low back pain, defined as pain between T12 vertebra and gluteal fold, persisting for more than three months, without known specific pathology. Eligible participants will be required to have an average pain intensity rating of at least 4/10 in the prior week, which will be rated on a verbal numeric rating scale at the time of telephone screening.
Exclusion criteria
History of spinal surgery, spinal trauma, structural scoliosis, or low back pain due to non-musculoskeletal causes (e.g., infection, visceral pain) will be excluded. Other exclusion criteria include pregnancy, less than 1 year post-natal or current lactation, inability to communicate in English, being a current or prior elite athlete (i.e., a member of Australian Institute of Sport), and any absolute contraindications for exercise training.
Outcome results
None listed