Potential Treatment Effect Modifiers for Manipulative Therapy for Children Complaining of Spinal Pain. Secondary Analyses of a Randomised Controlled Trial
SOURCE: Chiropractic & Manual Therapies 2019 (Dec 10)
Kristina Boe Dissing, Werner Vach, Jan Hartvigsen, Niels Wedderkopp & Lise Hestbæk
Department of Sports Science and Clinical Biomechanics,
Faculty of Health Sciences,
University of Southern Denmark,
Campusvej 55, DK-5230 Odense M, Denmark.
BACKGROUND: In children, spinal pain is transitory for most, but up to 20% experience recurrent and bothersome complaints. It is generally acknowledged that interventions may be more effective for subgroups of those affected with low back pain. In this secondary analysis of data from a randomized clinical trial, we tested whether five indicators of a potential increased need for treatment might act as effect modifiers for manipulative therapy in the treatment of spinal pain in children. We hypothesized that the most severely affected children would benefit more from manipulative therapy.
METHOD: This study was a secondary analysis of data from a randomised controlled trial comparing advice, exercises and soft tissue treatment with and without the years complaining of spinal pain. A text message system (SMS) and clinical examinations were used for data collection (February 2012 to April 2014).Five pre-specified potential effect modifiers were explored:
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Number of weeks with spinal pain 6 months prior to inclusion, number of weeks with co-occurring musculoskeletal pain 6 months prior to inclusion, expectations of the clinical course, pain intensity, and quality of life. Outcomes were number of recurrences of spinal pain, number of weeks with pain, length of episodes, global perceived effect, and change in pain intensity. To explore potential effect modification, various types of regression models were used depending on the type of outcome, including interaction tests.
RESULTS: We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.
CONCLUSIONS: This secondary analysis indicates that children more effected by certain baseline characteristics, but not pain intensity, have a greater chance to benefit from treatment that include manipulative therapy. However, these analyses were both secondary and underpowered, and therefore merely exploratory. The results underline the need for a careful choice of inclusion criteria in future investigations of manipulative therapy in children.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01504698
KEYWORDS: Adolescents; Back pain; Children; Effect modification; Manipulative therapy; Randomised controlled trial; Spinal pain
From the Full-Text Article:
In children, spinal pain, i.e. back and/or neck pain, is transitory for most, but up to 20% experience recurrent and bothersome complaints. [1, 2] Spinal pain in adolescence is a strong predictor for similar problems in adulthood [3–5], and spinal pain ranks third among individuals living with disability within the range of 15–19 years.  Thus, it is important to explore the parameters that may indicate effectiveness of treatments for spinal pain in these more severely affected children. Manipulative therapy is commonly being used, despite lack of evidence of its effectiveness in children0. [7–9] Current guidelines on treatment of spinal pain rely on studies of adults [10–12] and only one randomised controlled trial (RCT) including manipulative therapy for spinal pain have been conducted on children.  Because of the dire lack of evidence about treatment of spinal pain in children, data from existing studies should be exploited to the fullest.
For spinal pain, it is generally acknowledged that interventions may be more effective for subgroups of those affected. [14, 15] Studies of adult populations have found some variables with weak to strong evidence of a modifying effect on the treatment of spinal pain, e.g. age, expectations of treatment and quality of life. [16, 17] To our knowledge, no studies have investigated potential effect modifiers of treatment for spinal pain in children.
This study is a secondary analysis of data from an RCT investigating the effect of adding manipulative therapy to a standard treatment of advice, exercises and soft tissue treatment in Danish school children aged 9–15 years who report spinal pain.  In the primary analysis, we found a non-statistically significant advantage of the group not receiving manipulative therapy. Lack of significance may be due to different subgroups potentially responding differently to the interventions, it could also be due to broad inclusion criteria resulting in a heterogeneous study sample. In this paper, we therefore want to explore if we can identify potential treatment effect modifiers, i.e. certain baseline characteristics that may be associated with difference in outcomes between the two groups. Identification of such characteristics could potentially enhance clinical reasoning when selecting whether or not to include manipulative therapy in the treatment of spinal pain in children and should also be considered in future clinical trials. Because this was a small cohort, the analyses are explorative and can only be hypothesis-generating.
The aim of this study is thus to explore whether five indicators of a potential increased need for treatment act as effect modifiers for manipulative therapy in the treatment of spinal pain in children aged 9–15 years, namely:
Number of weeks with spinal pain 6 months prior to inclusion
Number of weeks with co-occurring musculoskeletal pain 6 months prior to inclusion
Expectations of the clinical course
Pain intensity at baseline
Quality of life at baseline