None listed
Conditions
Brief summary
Low back pain (LBP) represents a high social and economic burden and recent data suggests it is becoming an increasing problem. Further complicating the clinical picture is the presence of diverging approaches regarding how best to advise and manage persons with an acute episode of LBP. Over the past 20 years, there has been increasing support for a bio-psychosocial approach to the management of LBP. This model considers pain as a symptom not solely driven by tissue damage or pathology. Instead psychological and social influences such as fear avoidance, psychological distress, compensation or litigation status and job satisfaction are considered to contribute the pain experience. This bio-psychosocial model is in direct contrast to the prevailing historical model, the biomedical model which explains pain as a direct function of structural pathology. Central to the management of an acute episode of LBP and the prevention of chronic symptoms is the initial consultation between a patient with LBP and a health practitioner. Whether the practitioner subscribes to a biomedical or bio-psychosocial school of thought will determine the advice and management dispensed in a bout of uncomplicated acute LBP. Advice based on the biomedical model can be labelled Injury Model advice (IM), explaining the individuals’ symptoms in the context of tissue damage and emphasising initial protection of the injured tissue to optimise healing and recovery. The focus on specific diagnosis may appear intuitively reassuring, however there is evidence suggesting that having diagnostic radiology and a specific diagnosis may not actually provide reassurance. Furthermore, it has been suggested that emotional distress in acute LBP increases costly and inappropriate healthcare consultations. It is unknown whether being informed of tissue damage or a structural diagnosis actually increases the pain experience through cognitive or psychological drivers. The bio-psychosocially driven approach focuses on tissue sensitivity rather than injury and recognises that multiple factors interact to give rise to the sensitivity state. In this Tissue Sensitisation Model (TSM) providing reassurance and encouraging movement and function are seen as the key strategies to optimising recovery. This research aims for the first time to directly compare the efficacy of these two approaches to managing acute LBP. Using a safe, self-limiting and established delayed onset of muscle soreness protocol as a proxy for acute low back pain, we will compare the effect of the two models on physiological and neurophysiological measures of the pain experience and compare the recovery profile of each group.
Interventions
Base line testing and the intervention will will take place at Research Labs at Department of Health Science and Technology, Aalborg Universitet, Frederik Bajers Vej 7, 9220, Aalborg. The session is expected to last under 60 minutes.
All participants will be asked to report (online) their daily symptoms and will be requested to the following week.
Session 1
50 eligible, healthy, weight training naïve persons will be recruited. During Session 1 they will have baseline testing of all outcomes i
Base line testing and the intervention will will take place at Research Labs at Department of Health Science and Technology, Aalborg Universitet, Frederik Bajers Vej 7, 9220, Aalborg. The session is expected to last under 60 minutes. All participants will be asked to report (online) their daily symptoms and will be requested to the following week. Session 1 50 eligible, healthy, weight training naïve persons will be recruited. During Session 1 they will have baseline testing of all outcomes including pressure pain thresholds, questionnaire information, pain intensity on a numerical rating scale and movement evoked pain intensity on a numerical rating scale (See section: Outcomes). They will then be asked to perform exercises of the lumbar muscles. Participants will be requested to perform 4 sets of lumbar extension exercises until volitional fatigue. All exercise will be overseen by a qualified physiotherapist. The aim is to induce delayed onset muscle soreness (DOMS), a benign and temporary endogenous experimental pain. The exercise will only performed at the commencement of the study, it will not be repeated during follow up sessions. Baseline tests will be repeated at this point. Theses tests will be performed by a tester who will be blinded to group allocation. They will then be randomised into 2 arms which will each receive an advice based intervention from a qualified physiotherapist. These will be delivered in a face-to-face format with a predetermined script. They will also give the participant written material to re-inforce the particular messaging / advice. As these interventions are used in clinical practice but have not been compared in this way previously, they may both be considered active interventions. The only difference between the groups will be different information as to the cause of their pain and the advice they receive for the following days. Below are the intervention arms: Arm 1: Temporary Sensitisation Model Education & Advice: Arm 2: Injury Model Education & Advice: Immediately after receiving the education and advice, all baseline test will be repeated (again, blinded to allocation). The exercises will not be repeated. At the completion of testing on day 7, all participants will be de-briefed on the nature of the study / interventions via an online meeting. Arm 1: Temporary Sensitisation Model Education & Advice: This group will be advised that their muscles will likely become sensitive as a normal result of doing an unaccustomed exercise. They will be informed that there is no real injury and the best thing to can do in the next few days is to stay active and move normally and freely and to avoid guarding the back form movement.
Sponsors
University of Notre Dame Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
We will recruit from a healthy population. Inclusion criteria includes proficient written and spoken Danish and the ability to provide written informed consent.
Exclusion criteria
Participants to be excluded if they reported any form of persistent pain, had lower limb pain or low back pain that required a visit to a health care professional within the previous 12 months, sustained a traumatic injury (e.g. fracture or dislocation) of the lower limb or spine within the previous five years, had any ongoing medical or neurological conditions, consume regular anticoagulant medication or medications known to influence pain sensitivity (e.g. painkillers, anti-inflammatories, anti-depressants) or if they had recently trained the low back or legs with strength exercises (within the previous six-months).
Outcome results
None listed