Neck PainNCT03509649
Impact of Practitioner and Instructional Set on Subject Perceptions and Expectations of Cervical Spine Manipulation
A study testing Cervical spine manipulation in people with Neck Pain, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Determine effects of perceptions and expectations on experience of cervical spine manipulation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervical spine manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 17 May 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65 years;
- must report having no current episode of mechanical neck pain;
- must be willing to participate;
- must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years.
Who cannot join
- 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke.
- History of neck whiplash injury.
- Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms.
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes.
- Evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck).
- Prior surgery to your neck or upper back.
Show all 9Show fewer
- A medical condition which may change your sensation 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 think you may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas - Department of Physical Therapy
Las Vegas, Nevada, 89154
About this study
Official title: The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation
Determine effects of perceptions and expectations on experience of cervical spine manipulation
Read the detailed description
The purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. Current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.
- Conditions
- Neck Pain
- Being tested
- Cervical spine manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spine manipulationProcedure or surgery
High-velocity low-amplitude thrust joint manipulation to the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| Experienced - Positive | Experimental | Participants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician Receives: Procedure: Cervical spine manipulation |
| Experienced - Negative | Experimental | Participants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician Receives: Procedure: Cervical spine manipulation |
| Novice - Positive | Active comparator | Participants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician Receives: Procedure: Cervical spine manipulation |
| Novice - Negative | Active comparator | Participants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician Receives: Procedure: Cervical spine manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Perceived Effect Scale (GPE)
7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.
Measured: Immediate
Secondary outcomes (2)
Perception of comfort scale
5 point Likert scale ranging from 1 "very comfortable" to 5 "very uncomfortable
Measured: Immediate
Beliefs about cervical spine manipulation
6 questions determining participant's beliefs about safety, comfort and effectiveness of spinal manipulation. Likert scale with statements participants can 'completely disagree', 'somewhat disagree', 'neutral', 'somewhat agree', or 'completely agree' with
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Apr 2018
- Primary completion17 May 2019 (estimated)
- Study completion17 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Emilio J Puentedura, DPT, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509649
- Sponsor's protocol ID
- 1144771
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation
- ClinicalTrials.gov ID
- NCT03509649
- Acronym / sponsor ID
- 1144771
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 17 May 2019 (estimated)
- Study completion
- 17 May 2019 (estimated)
- First posted
- 26 Apr 2018 (actual)
- 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.
Determine effects of perceptions and expectations on experience of cervical spine manipulation
Detailed description
The purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. Current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experienced - Positive | Experimental | Procedure: Cervical spine manipulationParticipants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician |
| Experienced - Negative | Experimental | Procedure: Cervical spine manipulationParticipants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician |
| Novice - Positive | Active comparator | Procedure: Cervical spine manipulationParticipants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician |
| Novice - Negative | Active comparator | Procedure: Cervical spine manipulationParticipants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-65 years;
- must report having no current episode of mechanical neck pain;
- must be willing to participate;
- must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years.
Key exclusion criteria (9 listed)
- 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke.
- History of neck whiplash injury.
- Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms.
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes.
- Evidence of neurological signs suggesting 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 |
|---|---|---|
| Cervical spine manipulationHigh-velocity low-amplitude thrust joint manipulation to the cervical spine | Procedure or surgery | Experienced - Negative, Experienced - Positive, Novice - Negative, Novice - Positive |
Primary outcome
Global Perceived Effect Scale (GPE)
Time frame: Immediate
7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.
2 secondary outcomes
Perception of comfort scale
Time frame: Immediate
Beliefs about cervical spine manipulation
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Emilio J Puentedura, DPT, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical spine manipulation in people with Neck Pain, 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 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 2019. 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. 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?
Results are not available in the source record.
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?
Global Perceived Effect Scale (GPE) (time frame: Immediate). 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 18 Apr 2019.