Effects of Cervical Spine Manipulation on Gait

Cervicalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287324
• Other study ID #: UNLV-1303-4418
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: November 5, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Volunteers may or may not have mechanical neck pain

2. Aged 18 to 70 years

3. If neck pain is present, must have Neck Disability Index score of at least 10 out of 50 points

Exclusion Criteria:

1. '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.

2. History of neck whiplash injury

3. Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms

4. 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

5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)

6. Prior surgery to neck or upper back

7. 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)

8. Diagnosis from your physician of fibromyalgia syndrome

9. Currently pregnant, or could be pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cervicalgia
• Neck Pain

Intervention

Procedure:
• Manipulation

• Manual Contact

Locations

Country	Name	City	State
United States	UNLV	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Global Rating of Change Scale	Global rating of perceived change	Up to 10 minutes after intervention	No