Back Pain and Spinal Manipulation in Adolescent Scoliosis
Condition: Back Pain; Scoliosis
MeSH terms: Scoliosis; Back Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Spinal Manipulation Therapy; Usual Medical Care
Intervention type(s): Other; Other
Intervention description(s): Intervention will consist of Diversified type adjustments. Patients will be assigned to the nearest participating chiropractic clinic and will have a complete standardized examination on their first visit. Patient will then receive a maximum of 12 treatments (3x per week for a period of 4 weeks).; Usual interventions generally consist in the administration of medications (NSAIDs or ibuprofen), physical therapy or exercises. If recommended, physical therapy will be provided by the hospital physical therapy services. Physical therapy might include treatments such as massage, different electrotherapy, postural repositioning, exercises, etc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back Pain; Adolescent Idiopathic Scoliosis; Spinal Manipulation