Condition category
Musculoskeletal Diseases
Date applied
05/04/2005
Date assigned
08/04/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dale Rowe

ORCID ID

Contact details

1000 Oakland Drive
Kalamazoo
49008
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MSU-AIS

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.

Ethics approval

The Institutional Review Board of Borgess Medical Center, Kalamazoo approved the study protocol.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2001

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

6

Participant 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

Recruitment start date

01/08/2001

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United States of America

Trial participating centre

1000 Oakland Drive
Kalamazoo
49008
United States of America

Sponsor information

Organisation

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

Sponsor details

1000 Oakland Drive
Kalamazoo
49008
United States of America

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Michigan State University (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Memorial Chiropractic College, Toronto (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16923185

Publication citations

  1. Results

    Rowe DE, Feise RJ, Crowther ER, Grod JP, Menke JM, Goldsmith CH, Stoline MR, Souza TA, Kambach B, Chiropractic manipulation in adolescent idiopathic scoliosis: a pilot study., Chiropr Osteopat, 2006, 14, 15, doi: 10.1186/1746-1340-14-15.

Additional files

Editorial Notes