Effects of Cervical Spine Manipulation on Gait
Immediate Effects of Cervical Spine Manipulation on Gait Parameters in Individuals With and Without Mechanical Neck Pain
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of the study is to see if manipulation of the neck will change the way people who may or may not have neck pain, walk under differing conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedNovember 10, 2014
November 1, 2014
7 months
March 4, 2014
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait Parameters - Composite Score
A composite score derived from specific gait parameters which include stride length, step length, step width, cadence
Up to 10 minutes after intervention
Secondary Outcomes (1)
Global Rating of Change Scale
Up to 10 minutes after intervention
Study Arms (2)
Manipulation
ACTIVE COMPARATORHigh velocity low amplitude thrust joint manipulation to the cervical spine
Manual Contact
PLACEBO COMPARATORManual contact to suboccipital region of the cervical spine for 5 minutes
Interventions
Eligibility Criteria
You may qualify if:
- Volunteers may or may not have mechanical neck pain
- Aged 18 to 70 years
- If neck pain is present, must have Neck Disability Index score of at least 10 out of 50 points
You may not qualify if:
- 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
- History of neck whiplash injury
- Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
- Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
- Prior surgery to neck or upper back
- A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
- Diagnosis from your physician of fibromyalgia syndrome
- Currently pregnant, or could be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNLV
Las Vegas, Nevada, 89154, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 4, 2014
First Posted
November 10, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 10, 2014
Record last verified: 2014-11