Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-01 @ 9:32 AM
Study NCT ID:
NCT01765751
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial
Sponsor:
Palmer College of Chiropractic
Organization:
Study Overview
Official Title:
Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCD
Brief Summary:
The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, doctor treatment delivery, and believability characteristics of a commonly used chiropractic procedure for the treatment of neck- or neck-related arm pain or disability.
Detailed Description:
The purpose of the Manual Cervical Distraction (MCD): Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, and believability characteristics of a manually-localized cervical distraction procedure for the treatment of neck- or neck-related arm pain or disability. One challenging issue in the study of manual therapies, including spinal manipulation (SM), is the development of sham and/or minimal intervention procedures suitable for use with control groups in clinical trials. With SM, active treatment requires substantial physical contact between a study clinician and the study participant, either directly or through a mechanical intermediary. Consequently, it is difficult to introduce differences in manual therapy procedures that distinguish sham and/or minimal interventions from the active treatment, but are not immediately obvious to the study participant. Another challenging issue is training clinicians to deliver a standardized SM treatment within specified force ranges. The muscles surrounding the neck could alter the forces transmitted to the cervical spine, and could alter the treatment effectiveness. The purpose of this pilot randomized controlled trial is to examine the patient-centered clinical, biomechanical, and believability outcome characteristics of a manually-localized cervical distraction procedure for the treatment of neck or neck-related arm pain or disability. We also will evaluate the ability of the doctor of chiropractic to deliver the MCD treatment within specified force ranges. An exploratory aim of this study is to evaluate EMG measurement during MCD delivery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: