CervicalgiaNCT02287324
Effects of Cervical Spine Manipulation on Gait
A study testing Manipulation and Manual Contact in people with Cervicalgia, run by University of Nevada, Las Vegas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicalgia
- What is being tested?
- Manipulation and Manual Contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- '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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Cervical Spine Manipulation on Gait Parameters in Individuals With and Without Mechanical Neck Pain
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.
Read the 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.
- Conditions
- Cervicalgia
- Being tested
- Manipulation, Manual Contact
- Keywords
- Cervicalgia
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManipulationProcedure or surgery
Manual ContactProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Active comparator | High velocity low amplitude thrust joint manipulation to the cervical spine Receives: Procedure: Manipulation |
| Manual Contact | Placebo comparator | Manual contact to suboccipital region of the cervical spine for 5 minutes Receives: Procedure: Manual Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Parameters - Composite Score
A composite score derived from specific gait parameters which include stride length, step length, step width, cadence
Measured: Up to 10 minutes after intervention
Secondary outcomes (1)
Global Rating of Change Scale
Global rating of perceived change
Measured: Up to 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287324
- Sponsor's protocol ID
- UNLV-1303-4418
- Status last verified
- Nov 2014
- First submitted
- 4 Mar 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Cervical Spine Manipulation on Gait Parameters in Individuals With and Without Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02287324
- Acronym / sponsor ID
- UNLV-1303-4418
- Conditions
- Cervicalgia
- Keywords
- Cervicalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Active comparator | Procedure: ManipulationHigh velocity low amplitude thrust joint manipulation to the cervical spine |
| Manual Contact | Placebo comparator | Procedure: Manual ContactManual contact to suboccipital region of the cervical spine for 5 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- '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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulation | Procedure or surgery | Manipulation |
| Manual Contact | Procedure or surgery | Manual Contact |
Primary outcome
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
1 secondary outcome
Global Rating of Change Scale
Time frame: Up to 10 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
Related trials for Cervicalgia
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Recruiting
Kinesiology Taping Versus Self-Mobilization for Neck Pain Related to Prolonged Electronic Device Use
Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation and Manual Contact in people with Cervicalgia, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Parameters - Composite Score (time frame: Up to 10 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.