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Effects of Cervical Spine Manipulation on Gait

Primary Purpose

Cervicalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Manipulation

Manual Contact

About this trial

This is an interventional basic science trial for Cervicalgia focused on measuring Cervicalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

'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

Sites / Locations

UNLV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Manipulation

Manual Contact

Arm Description

High velocity low amplitude thrust joint manipulation to the cervical spine

Manual contact to suboccipital region of the cervical spine for 5 minutes

Outcomes

Primary Outcome Measures

Gait Parameters - Composite Score

A composite score derived from specific gait parameters which include stride length, step length, step width, cadence

Secondary Outcome Measures

Global Rating of Change Scale

Global rating of perceived change

Full Information

NCT ID

NCT02287324

First Posted

March 4, 2014

Last Updated

November 5, 2014

Sponsor

University of Nevada, Las Vegas

1. Study Identification

Unique Protocol Identification Number

NCT02287324

Brief Title

Effects of Cervical Spine Manipulation on Gait

Official Title

Immediate Effects of Cervical Spine Manipulation on Gait Parameters in Individuals With and Without Mechanical Neck Pain

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Nevada, Las Vegas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Volunteers in this study will be asked to do the following: 1) complete a series of questionnaires about health status and undergo physical screening of neck to make sure that manipulation will not be harmful; 2) walk in socks or bare feet across a computerized mat under 3 conditions - normal walking pace, walking while looking up and down repeatedly; and walking while looking left and right repeatedly; 3) have one of 2 manual therapy interventions to the neck; 4) repeat the walking across the computerized mat under those same 3 conditions. The 2 randomly assigned interventions are: cervical manipulation, or cervical contact. If assigned the manipulation, volunteers will lie face up and the trained therapist will move the joints in the neck in a gentle, but short and sharp manner which may produce a slight 'pop' or 'click'. If volunteers are assigned the cervical contact, they will lie on their back and the trained therapist will gently hold the head and neck for 45 to 60 seconds as they quietly relax.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervicalgia

Keywords

Cervicalgia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manipulation

Arm Type

Active Comparator

Arm Description

High velocity low amplitude thrust joint manipulation to the cervical spine

Arm Title

Manual Contact

Arm Type

Placebo Comparator

Arm Description

Manual contact to suboccipital region of the cervical spine for 5 minutes

Intervention Type

Procedure

Intervention Name(s)

Manipulation

Intervention Type

Procedure

Intervention Name(s)

Manual Contact

Primary Outcome Measure Information:

Title

Gait Parameters - Composite Score

Description

A composite score derived from specific gait parameters which include stride length, step length, step width, cadence

Time Frame

Up to 10 minutes after intervention

Secondary Outcome Measure Information:

Title

Global Rating of Change Scale

Description

Global rating of perceived change

Time Frame

Up to 10 minutes after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: '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

Facility Information:

Facility Name

UNLV

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89154

Country

United States

12. IPD Sharing Statement

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Effects of Cervical Spine Manipulation on Gait

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