Back Pain and Spinal Manipulation in Adolescent Scoliosis
Back Pain and Spinal Manipulation in Adolescent Scoliosis
Adolescent idiopathic scoliosis (AIS) affects 2 - 3% of children and adolescents older than
 10 years and is of unknown cause. It was initially thought that occurrences of back pain (BP)
 were similar to the one encounter in healthy adolescents. Recently, literature has shown that
 there is a two-fold prevalence of BP among AIS patients compared to healthy adolescents. As
 such, BP appears as a condition that might have a detrimental effect on the well-being of AIS
 patients and seems associated with increases in health care costs. Further, BP in adolescents
 would appear to be a predictive factor for adult BP. Is vertebral manipulation (VM) a viable
 alternative? Since 2006, four guidelines were in agreement as to the value of that approach
 with acute or chronic BP in adults. Unfortunately, no study was found in adolescents. The
 purpose of the study is to verify if VM is efficacious at improving AIS patients' back pain
 and to find out if it can help these patients to obtain a better quality of life and improve
 their spinal flexibility. Recruitment will take place at Ste Justine's hospital where
 patients will have 2 evaluations, conducted by an independent orthopaedist (baseline and 4
 weeks). Patients will be allocated to either the experimental (VM) or the usual medical care
 group. Spinal manipulation treatment will last over a 4-week period. The study will be the
 first trial evaluating the efficacy of vertebral manipulation in adolescent idiopathic
 scoliosis patients with back pain. Finally, no other study was found on available and
 effective treatment regarding back pain management for this population. A well-structured
 trial is needed to provide clinicians with a better understanding and best evidence regarding
 treatment protocols.
Introduction Adolescent Idiopathic Scoliosis (AIS) is defined by the Scoliosis Research
 Society (SRS) has a three-dimensional deviation of the vertebral column of unknown origin
 appearing in adolescents older than 10 years. Chronic non-specific back pain (CNSBP) is often
 associated with adolescent scoliosis patients, and the associated prevalence is almost double
 that of non-scoliosis healthy adolescents. Furthermore, CNSBP seems to be a predictor of
 CNSBP in adulthood.

 Few studies evaluated BP among AIS patients and in those who did, conflicting results,
 regarding back pain prevalence, were observed. Among these, only two studies looked at back
 pain in adolescent idiopathic scoliosis. Ramirez et al. retrospectively evaluated, 2442
 scoliosis adolescent patients' files establishing BP prevalence at 32%. He concluded that the
 established prevalence was similar to the one encountered in a general non-scoliotic
 adolescent population. Joncas and Labelle prospectively evaluated 239 adolescents with
 idiopathic scoliosis for the prevalence of BP. They observed that BP occurred in 54% of
 patients, and the average pain intensity was 49,4 mm. More recently, Sato's studied back pain
 prevalence in adolescents with idiopathic scoliosis. He conducted a large-scale
 cross-sectional epidemiological study, where 43 630 children aged 9 to 15-year-old were
 required to complete a take-home questionnaire. They reported a back pain prevalence of 58.8%
 in scoliosis patients compared to 32.9% in non-scoliosis patients.

 Regarding BP Management in AIS Patients, a comprehensive review of the literature did not
 yield any study on BP management in AIS patients. Spinal manipulation therapy (SMT) is a
 recognised and safe treatment for low back pain and is performed primarily by chiropractors,
 physical therapists, and osteopaths. To the best of the investigators' knowledge, only one
 pilot clinical trial (Rowe 2006) has been conducted with children and adolescents diagnosed
 with AIS. Though under powered, results showed that SMT was associated with only minor
 adverse events, there was no curve progression in the treatment group, and quality of life,
 evaluated by the Scoliosis Quality of life Index, has not been negatively impacted.

 In light of the paucity of literature on the management of back pain in nonsurgical AIS
 patients, and considering the lack of evidence in regards to the efficacy of SMT for back
 pain in adolescents, and the lack of guidance regarding management of back pain in
 adolescents, it would be important to evaluate the effectiveness of SMT compared to usual
 medical care for back pain among adolescents with idiopathic nonsurgical scoliosis.

 The primary objective of this pilot study is to verify the effect of Spinal Manipulative
 Therapy on back pain management of adolescents with idiopathic nonsurgical scoliosis. The
 secondary objectives are two-fold: 1) to verify the effect of SMT on low back function, 2) to
 verify the feasibility and acceptability of SMT according to patients' level of satisfaction.
 This pilot study will be used to verify some implementation strategies before proceeding to a
 subsequent larger trial, such as recruitment rate, treatment compliance and loss to follow
 up, and adverse events.

 Methods: Study Design This pilot study is a single prospective centre randomised controlled
 trial with one experimental and one control group. This study will be recruiting from
 Ste-Justine University Hospital in Montreal, Canada, and patients will be required to attend
 at least 80% of the treatment sessions otherwise they will be considered as non-compliant.
 Chiropractors will be recruited from their professional regulatory board. Different
 instruments will be used during this trial: questionnaires; the Brief Pain Inventory
 Questionnaire, and the Roland-Morris Disability Questionnaire; the modified
 Fingertip-to-floor distance, the modified-modified Schöber test, and the Biering-Sorenson
 back muscles extensor test. Patients will be evaluated upon trial entry and at 4 weeks (end
 of trial). Co-interventions will be documented and accounted in the analysis. Eligible
 patients will be randomized according to blocks of 4 to either the experimental (SMT) or the
 control (UMC) arm after informed consent has been obtained. The randomisation list will be
 generated and managed by an independent statistician. Statistical software SPSS version 22
 will be used for data analyses. All analyses will be conducted under the intention-to-treat
 principle. To ensure balance, groups will be compared for possible confounders (age, gender,
 brace) at baseline. The group mean (Std. Deviation) and frequencies will be presented. Tests
 will be 2-tailed, and the significance level will be set at 0.05. Statistical analysis will
 include t-test (or Mann-Whitney) for continuous variables and χ2 for categorical variables.
 Considering that patient's inclusion criterion is chronic pain, and that by definition
 chronic pain is defined as constant over a period; the investigators expect this variable not
 to be time influenced. Ste-Justine University Hospital ethical committee has approved this
 study.
Inclusion Criteria:

 1. Adolescents 10 to 17-year-old of either gender

 2. Both, parents and adolescents speak either English or French

 3. Adolescents with a diagnosis of AIS established by one of the participating
 orthopaedists.

 4. Pain score over 3 on scale of 0-10

 5. AIS associated with mechanical back pain of at least six consecutive weeks duration
 with or without radiating pain to the lower extremity. Mechanical back pain is defined
 as pain not associated with specific identifiable aetiologies

 Exclusion Criteria:

 1. suffering from any metabolic, malignant or any serious organic or progressive
 neurological deficit.

 2. any structural disturbances of the spine is present (e.g.: osteoporosis, disc
 herniation, spondylolisthesis, hip dysplasia and others),

 3. previous back surgery for AIS

 4. ongoing treatment for back pain by other health care providers

 5. pregnancy

 6. contraindications to SMT, other than previously mentioned, such as inflammatory or
 infectious conditions, blood clotting and connective tissue disorders