Key messages
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IMT is more effective than advice in patients
Low-back-disorders (LBD) are a major cause of disability adjusted life years [1] as well as being prevalent and costly [2]. Recent onset LBD improve rapidly but symptoms commonly persist and/or recur [3] and the identification of effective treatment is a high research priority [4].
Advice for LBD has demonstrated positive effects on clinical outcomes [5], is cost-effective [6], requires no additional training [7] and is commonly used in clinical practice. Advice is also recommended in clinical guidelines for LBD [4]. However, LBD can be complex and advice may not lead to positive outcomes for all patients [8], [9].
Manual therapy is a common physiotherapy treatment for LBD [10], [11] but evidence of effectiveness remains limited [12]. However, clinical trials often use a generic approach to manual therapy rather than individualising treatment based on pathoanatomical (e.g. nociceptive source of symptoms), psychosocial (e.g. fear avoidance), and neurophysiological (e.g. central sensitisation) barriers to recovery [13], [14], [15], [16]. An individualised approach to manual therapy is more reflective of clinical practice and has been described as being more likely to demonstrate effectiveness in randomised controlled trials (RCTs) [13], [14], [15], [16].
Preliminary evidence has been published in a systematic review supporting the effectiveness of individualised manual therapy for LBD [17]. However none of the RCTs identified evaluated a manual therapy program based on the commonly used [10] Maitland approach [18] in combination with addressing individual barriers to recovery such as altered motor control [19]. In addition no clinical trial has investigated the effectiveness of manual therapy on patients with a “regular compression” pattern of localised unilateral pain reproduced on lumbar extension and ipsilateral lateral flexion [20]. This commonly observed [21] presentation has been reported as responding in a consistent and predictable manner to manual therapy techniques [18], [22], [23] and may comprise features indicative of lumbar zygapophyseal joint pain [24].
The aim of this trial was therefore to report the findings of a preplanned subgroup analysis to determine the effectiveness of individualised manual therapy (IMT) plus guideline-based advice compared to advice alone in people with LBD and clinical features potentially indicative of lumbar zygapophyseal joint (LZJ) origin.
A multi centre parallel group randomised controlled trial was conducted at 16 private physiotherapy clinics across metropolitan Melbourne, Australia. Ethical approval was provided by the La Trobe University Human Ethics Committee and informed consent received from all participants prior to enrolment.
The trial was prospectively registered (ACTRN12609000334202). Recruitment and treatment occurred concurrently with four other trials, each targeting a different LBD subgroup. After registration, a
Recruitment took place between 28th April 2009 and 30th March 2012. When the STOPS trial reached its target enrolment, 64 participants with LZJ pain had been enrolled from a total 2038 screened volunteers. Fig. 1 presents the flow of participants through the trial. The most common reason for exclusion was duration of symptoms >6 months (n = 857), duration of symptoms <6 weeks (n = 94), meeting the eligibility criteria of one of the other four STOPS subgroups (n = 236), or not meeting eligibility
This trial shows that people with LBD and clinical features indicative of LZJ experience greater and more rapid improvements in back pain (at 5, 10 and 26-weeks) and activity limitation (at 26 and 52-weeks) with IMT and guideline-based advice compared to advice alone. The size of between-group differences was close to the commonly accepted MCID [48]. To further explore clinical importance and in accordance with our a-priori statistical plan [27], a primary outcome responder analysis was
In patients with clinical features potentially indicative of LZJ pain, IMT with guideline-based advice is more effective than advice alone for achieving faster improvements in back pain as well as faster and sustained improvement in activity limitation, but not for improvement in leg pain. The outcomes appear clinically important. Physiotherapists should consider providing IMT to patients with features potentially indicative of LZJ pain. Key messages IMT is more effective than advice in patients
We wish to acknowledge the trial-physiotherapists who volunteered to treat participants in this trial free of charge. We also acknowledge LifeCare Health for providing facilities, personnel and resources to allow treatment of trial participants free of charge. We thank Dr. Siew-Pang Chan (Biostatistician) for his advice regarding statistical analysis and Dr Rana Hinman for guidance re trial design. We acknowledge La Trobe University for internal research funding awarded to JF, AH, SS, LS, AC,