Back Pain and Spinal Manipulation in Adolescent Scoliosis

NCT02609009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Spinal Manipulation Therapy

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).

OTHER

Usual Medical Care

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

Sponsors & Collaborators

  • Fondation Chiropratique du Québec

    collaborator OTHER
  • St. Justine's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-04-05
Completion
2017-05-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609009 on ClinicalTrials.gov