Back Pain and Spinal Manipulation in Adolescent Scoliosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02609009
• Date of registration: 17/11/2015
• Prospective Registration: No
• Primary sponsor: St. Justine's Hospital
• Public title: Back Pain and Spinal Manipulation in Adolescent Scoliosis
• Scientific title: Back Pain Management With Spinal Manipulation Therapy Compared to Usual Medical Care in Adolescent Idiopathic Scoliosis Patients: A Pilot Study
• Date of first enrolment: September 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609009
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Scoliosis

Back Pain

Intervention(s)

Other: Usual Medical Care

Other: Spinal Manipulation Therapy

Primary Outcome(s)

Back Pain intensity [Time Frame: 4 weeks]

Secondary Outcome(s)

Physical Functioning [Time Frame: The RMDQ will be administered at baseline and at four week follow up.]

Isometric trunk extensor muscles endurance. [Time Frame: The spinal forward flexion will be administered at baseline and at four week follow up.]

Spinal forward flexion [Time Frame: The spinal forward flexion will be administered at baseline and at four week follow up.]

Secondary ID(s)

3928

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondation Chiropratique du Québec