Chiropractic Manipulation in Adolescent Idiopathic Scoliosis: a pilot study

ISRCTN	ISRCTN41221647
DOI	https://doi.org/10.1186/ISRCTN41221647
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Dale Rowe
Scientific

1000 Oakland Drive
Kalamazoo
49008
United States of America

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	MSU-AIS
Study objectives	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.
Ethics approval(s)	The Institutional Review Board of Borgess Medical Center, Kalamazoo approved the study protocol.
Health condition(s) or problem(s) studied	Adolescent Idiopathic Scoliosis (AIS)
Intervention	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
Intervention type	Other
Primary outcome measure	The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2001
Completion date	31/08/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	6
Key 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
Key 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
Date of first enrolment	01/08/2001
Date of final enrolment	31/08/2003

1000 Oakland Drive

Kalamazoo
49008
United States of America

Michigan State University (USA) - Kalamazoo Center for Medical Studies
University/education

1000 Oakland Drive
Kalamazoo
49008
United States of America

"ROR"	https://ror.org/05hs6h993

University/education

Michigan State University (USA)

No information available

Kalamazoo Center for Medical Studies, Kalamazoo, Michigan (USA)

No information available

American Chiropractic Scoliosis Foundation, Fort Collins, Colorado (USA)

No information available

Canadian Memorial Chiropractic College, Toronto (Canada)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	21/08/2006		Yes	No