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OpenTrials
Completed

NCT Number: NCT02287324

Effects of Cervical Spine Manipulation on Gait

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNLV

Las Vegas, Nevada, 89154, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manipulation

Procedure

Manual Contact

Procedure

Primary outcomes

  1. Gait Parameters - Composite Score

    Time frame: Up to 10 minutes after intervention

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

Secondary outcomes

  1. Global Rating of Change Scale

    Time frame: Up to 10 minutes after intervention

    Global rating of perceived change

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 10, 2014
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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