Musculoskeletal PainNCT05221125
Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
A study testing Psychologically-Informed Physical Therapy (PIPT) in people with Musculoskeletal Pain, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Psychologically-Informed Physical Therapy (PIPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 31 Jul 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (age 18 years or older),
- Presented to the ED with pain in the neck and/or back,
- A diagnosis of musculoskeletal pain as determined by an ED provider,
- Able to read and understand the consent form in English.
Who cannot join
- Suspected to have a non-musculoskeletal cause of pain;
- Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
- Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
- ED provider judgment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital Emergency Department
Durham, North Carolina, 27710
About this study
Official title: Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.
We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.
- Conditions
- Musculoskeletal Pain
- Being tested
- Psychologically-Informed Physical Therapy (PIPT)
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychologically-Informed Physical Therapy (PIPT)Behavioural
The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.
| Study group | Role | What they receive |
|---|---|---|
| Psychologically-Informed Physical Therapy (PIPT) | Experimental | CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge Receives: Behavioral: Psychologically-Informed Physical Therapy (PIPT) |
| Control | No intervention | Usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ED patients eligible for recruitment as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients that found treatment satisfactory via satisfactory questionnaire
5 point Likert-scale satisfaction scale
Measured: Post implementation, up to 6 weeks
Secondary outcomes (12)
Change in Pain Score
11-point Numeric Rating Scale (NRS) for current pain
Measured: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Anxiety Level
Subjective Units of Discomfort Scales (SUDS)
Measured: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Function
PROMIS-29
Measured: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Quality of Life (QoL)
PROMIS-29
Measured: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in pain related distress
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Measured: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in self efficacy
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Measured: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in severity of chronic pain
Simplified graded chronic pain scale
Measured: ED pre-treatment (baseline); 1 and 3 months post discharge
Number of pain medications prescribed
as measured by chart review
Measured: up to 3 months post discharge
Number of Spine Health referrals for follow up PT
as measured by chart review
Measured: At ED discharge (up to 48 hours)
Number of Spine Health visits for follow up PT
as measured by chart review
Measured: up to 3 months post discharge
Number of repeat ED visits
as measured by chart review
Measured: up to 3 months post discharge
Number of patient hospitalizations
as measured by chart review
Measured: up to 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start6 Jun 2022
- Primary completion20 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Corey Simon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221125
- Sponsor's protocol ID
- Pro00110289
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
- ClinicalTrials.gov ID
- NCT05221125
- Acronym / sponsor ID
- Pro00110289
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Feb 2022 (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.
The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.
We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychologically-Informed Physical Therapy (PIPT) | Experimental | Behavioral: Psychologically-Informed Physical Therapy (PIPT)CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge |
| Control | No intervention | –Usual care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age 18 years or older),
- Presented to the ED with pain in the neck and/or back,
- A diagnosis of musculoskeletal pain as determined by an ED provider,
- Able to read and understand the consent form in English.
Key exclusion criteria (4 listed)
- Suspected to have a non-musculoskeletal cause of pain;
- Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
- Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
- ED provider judgment.
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 |
|---|---|---|
| Psychologically-Informed Physical Therapy (PIPT)The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition. | Behavioural | Psychologically-Informed Physical Therapy (PIPT) |
Primary outcome
Number of ED patients eligible for recruitment as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients that found treatment satisfactory via satisfactory questionnaire
Time frame: Post implementation, up to 6 weeks
5 point Likert-scale satisfaction scale
12 secondary outcomes
Change in Pain Score
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Anxiety Level
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Function
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Quality of Life (QoL)
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in pain related distress
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in self efficacy
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in severity of chronic pain
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Number of pain medications prescribed
Time frame: up to 3 months post discharge
Number of Spine Health referrals for follow up PT
Time frame: At ED discharge (up to 48 hours)
Number of Spine Health visits for follow up PT
Time frame: up to 3 months post discharge
Number of repeat ED visits
Time frame: up to 3 months post discharge
Number of patient hospitalizations
Time frame: up to 3 months post discharge
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 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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.
Corey Simon, PhD principal investigator
Duke 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 Psychologically-Informed Physical Therapy (PIPT) in people with Musculoskeletal Pain, run by Duke University 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 4 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 11 Aug 2026. 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 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?
Number of ED patients eligible for recruitment as measured by patient log (time frame: Post implementation, up to 6 weeks). The study lists 4 primary outcomes in all. 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 11 Aug 2026.