Welcome
Support Centre
31 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Chiropractic Manipulation in Adolescent Idiopathic Scoliosis: a pilot study
ISRCTN ISRCTN41221647
DOI 10.1186/ISRCTN41221647
ClinicalTrials.gov identifier
EudraCT number
Public title Chiropractic Manipulation in Adolescent Idiopathic Scoliosis: a pilot study
Scientific title
Acronym MSU-AIS
Serial number at source N/A
Study hypothesis A large scale, multi-disciplinary, collaborative clinical trial is needed to explore the effectiveness of chiropractic manipulation of patients with Adolescent Idiopathic Scoliosis (AIS). But prior to conducting such a trial, we needed to perform a pilot randomised controlled trial to explore issues of safety, patient recruitment and compliance, treatment standardisation, sham treatment refinement, inter-professional cooperation, quality assurance, outcome measure selection and statistical analysis.
Lay summary
Ethics approval The Institutional Review Board of Borgess Medical Center, Kalamazoo approved the study protocol.
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Adolescent Idiopathic Scoliosis (AIS)
Participants - inclusion criteria 1. Children aged 10 - 16 years
2. Diagnosis of Adolescent Idiopathic Scoliosis
3. Spinal curvature on Posterior/Anterior (P/A) radiographs of between 20 and 30 degrees measured by the Cobb method in non-braced individuals and 30 to 40 degrees in braced individuals
4. Palpatory evidence of subluxation (manipulative lesion) on chiropractic screening examination
5. No contraindications to spinal manipulative therapy
6. Signed informed consent by parent/guardian
7. Signed child assent form
8. Availability for follow-up evaluation
Participants - exclusion criteria 1. Age less than 10 or greater than 16 years
2. Diagnosis other than AIS following clinical, radiographic and advanced imaging assessment
3. Contraindications to manipulation
4. Congenital or acquired structural spinal abnormalities
5. Leg length inequality greater than 3/8 inch
6. Pregnancy
7. Pain as a primary clinical feature
8. Mentally incapacitated patient
9. Planning to move/unwilling to return for follow-up
10. Previous back surgery
11. Significant trauma
12. Obesity impairing ability to manipulate
Anticipated start date 01/08/2001
Anticipated end date 31/08/2003
Status of trial Completed
Patient information material
Target number of participants 6
Interventions Patients were treated for six months by:
1. Standard medical care (observation or brace treatment)
2. Standard medical care plus chiropractic manipulation
3. Standard medical care plus sham manipulation
Primary outcome measure(s) The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Michigan State University (USA)
2. Kalamazoo Center for Medical Studies, Kalamazoo, Michigan (USA)
3. American Chiropractic Scoliosis Foundation, Fort Collins, Colorado (USA)
4. Canadian Memorial Chiropractic College, Toronto (Canada)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16923185
Contact name Dr  Dale  Rowe
  Address 1000 Oakland Drive
  City/town Kalamazoo
  Zip/Postcode 49008
  Country United States of America
Sponsor Michigan State University (USA) - Kalamazoo Center for Medical Studies
  Address 1000 Oakland Drive
  City/town Kalamazoo
  Zip/Postcode 49008
  Country United States of America
Date applied 05/04/2005
Last edited 15/02/2008
Date ISRCTN assigned 08/04/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.