Comparing the outcomes of two physiotherapy treatment approaches for persistent low back pain.

INTERVENTION: Physiotherapy treatment A. Participants will receive 1 x 45‐minute physiotherapy assessment plus 12 x 30‐minute physiotherapy treatment sessions over a 6‐month period. All participants will be treated by qualified and registered physiotherapists at one of four private physiotherapy clinics throughout Melbourne, Australia. To protect trial blinding, the nature of the physiotherapy treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made publically available at the conclusion of the trial. Treatment fidelity will be monitored by the submission of the physiotherapist's treatment notes to the researchers for every patient. CONDITION: Persistent low back pain PRIMARY OUTCOME: Activity limitation: measured with the Oswestry Low Back Pain Disability Index. Back pain intensity: measured with a 0‐10 Numerical Rating Scale Leg pain intensity: measured with a 0‐10 Numerical Rating Scale SECONDARY OUTCOME: Adherence will be measured in three ways: ; 1) .Number of physiotherapy sessions attended. ; 2) Patient self‐report of adherence at each follow‐up: "On a scale of 0‐10, how adherent have you been to following the advice and exercises recommended by your physiotherapist" (from “not at all” to “fully”) ; 3) Therapist rating of patient adherence after each session attended: "On a scale of 0‐10, how adherent has the patient been to following your advice and exercises since the last session" (from “not at all” to “fully”) ; ; Adverse events: measured via two methods developed for this trial: ; 1) Participant self‐report on follow‐up questionnaires (open question: "Have you noticed any adverse, harmful or unpleasant effects that you think may have been due to the ; treatment program that you undertook in this trial? If so, please explain".) ; 2) Treating physiotherapist reporting at each treatment session recorded on clinical notes ("Please record any adverse events reported by the participant since the last treatment session, or during today's treatment session"). Baseline clinical assessment information: Obtained via the Subjective Complaints Questionnaire, and the Pain Drawing Baseline prognosis: measured using the StartBack screening tool Central sensitisation: measured with the Central Sensitization Inventory Credibility of treatment: measured using a modified treatment credibility / expectations questionnaire. ; 1) At this point, how logical does the treatment offered to you seem? (0‐10 scale) ; 2) At this point, how successful do you think this treatment will be in helping you with your back problem? (0‐10 scale) ; 3) How confident would you be in recommending this treatment to a friend who experiences similar problems? (0‐10 scale) INCLUSION CRITERIA: i) A primary complaint of either low back pain or back‐related leg pain ii) Duration of current episode of at least 6 months iii) Aged between 18 and 65 years iv) Sufficient fluency in English to complete outcome questionnaires ; 4) By the end of your treatment, how much improvement in your back condition do you think will occur? (0‐100%) Depression, anxiety and stress: measured using the Depression Anxiety & Stress Scales (DASS‐21). This is a composite questionnaire that allows collation of sub‐scales relating to depression, anxiety and stress from the one questionnaire. Fear of movement / activity: measured using the Tampa Scale of Kinesiophobia Global rating of change: measured on a 7‐point Global Rating of Change Scale ranging from “vastly worsened” to “completely recovered” Health related quality of life: measured using two tools, 1) EuroQol‐5D, and 2) The Assessment of Quality of Life (AQoL‐8D). These will also be the "effectiveness" measures for the cost‐effectiveness analysis, with the Euro‐Qol‐5D being the primary measure and the AQoL‐8D being the secondary / sensitivity measure). Healthcare utilisation: recorded via a participant diary where each participant will record the nature and dosage (number of sessions attended, number of injections received etc) of all healthcare received. This will include medical consultations, other healthcare consultations (eg. physiotherapy, chiropractic, massage), medical interventions (eg. injections or surgery) and radiological imaging procedures. These data will also form part of the "cost" data for the cost‐effectiveness analysis. Medication use: measured via a participant diary over the last 24‐hours. These data will also form part of the "cost" data for the cost‐effectiveness analysis. Neuropathic pain: measured with the Neuropathic Pain Questionnaire (original full‐length English version) Pain catastrophising: measured with the Pain Catastrophising Scale Pain self‐efficacy: measured using the Pain Self‐efficacy Questionnaire Psychosocial distress: measured with the Orebro Musculoskeletal Pain Questionnaire Success of blinding: Participants will be asked if they know what the two physiotherapy approaches being compared in the trial are, and if so, which approach they received. Treatment satisfaction: measured on a 5‐point scale from “very dissatisfied” to “completely satisfied” Work absence: number of work days missed due to low back condition in the last 30 days, measured via a question on follow‐up questionnaires ("in the last 30 days, how many days did low back pain or leg pain (sciatica) prevent you from going to work or school"?) These data will also form part of the "cost" data for the cost‐effectiveness analysis.