Orthopaedic Related Pain (Musculoskeletal Pain)NCT02710695
Pain in America: A Randomized Controlled Trial
A study testing Intervention in people with Orthopaedic Related Pain (Musculoskeletal Pain), run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Related Pain (Musculoskeletal Pain)
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers
Who cannot join
- Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMKC Department of Orthopaedic Surgery
Kansas City, Missouri, 64108
About this study
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.
- Being tested
- Control, Intervention
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
This group will receive a standardized 10 minute discussion.
InterventionBehavioural
This group will receive a standardized 10 minute discussion
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will receive a 10 minute discussion Receives: Behavioral: Control |
| Intervention | Active comparator | This group will receive a 10 minute standardized discussion Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
Validated Questionnaire
Measured: 15 minutes
Secondary outcomes (1)
Surveys
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Lack of available time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic Related Pain (Musculoskeletal Pain)Studies 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, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkemakolam Egekeze, University of Missouri, Kansas City
- Investigators
- Nkem Egekeze, MD, Principal investigator, UMKC Department of Orthopaedic SurgeryCharles Rhoades, MD, Study director, UMKC Department of Orthopaedic SurgeryMark Bernhardt, MD, Study director, UMKC Department of Orthopaedic SurgeryKaren Williams, PhD, Study director, UMKC Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710695
- Sponsor's protocol ID
- 16-026
- Status last verified
- Apr 2018
- First submitted
- 12 Mar 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in America: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02710695
- Acronym / sponsor ID
- 16-026
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of available time
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Mar 2016 (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.
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlThis group will receive a 10 minute discussion |
| Intervention | Active comparator | Behavioral: InterventionThis group will receive a 10 minute standardized discussion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers
Key exclusion criteria (1 listed)
- Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.
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 |
|---|---|---|
| ControlThis group will receive a standardized 10 minute discussion. | Behavioural | Control |
| InterventionThis group will receive a standardized 10 minute discussion | Behavioural | Intervention |
Primary outcome
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
Time frame: 15 minutes
Validated Questionnaire
1 secondary outcome
Surveys
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: Lack of available time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
Nkem Egekeze, MD principal investigator
UMKC Department of Orthopaedic Surgery
Charles Rhoades, MD study director
UMKC Department of Orthopaedic Surgery
Mark Bernhardt, MD study director
UMKC Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Orthopaedic Related Pain (Musculoskeletal Pain), run by University of Missouri, Kansas City 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Apr 2018. 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?
The study was stopped early (reason given: Lack of available time). 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?
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT" (time frame: 15 minutes). 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 26 Apr 2018.