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Can physical therapy with a psychological twist tame ER back pain?

NCT ID NCT05221125

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This pilot study explores whether a specialized form of physical therapy, called psychologically-informed physical therapy (PIPT), can be effectively delivered in the emergency department for adults with neck or back pain. Participants will either receive usual care or usual care plus PIPT, which combines physical therapy with psychological strategies to address pain. The study primarily aims to see if this approach is feasible and acceptable to patients, while also tracking pain levels, anxiety, function, and opioid use over three months. Results will help design a larger trial to test this innovative model more rigorously.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Psychologically-Informed Physical Therapy (PIPT), a behavioral intervention combining physical therapy with psychological principles
What this could lead to
If successful, this approach could offer a new way to manage neck and back pain in emergency settings, potentially reducing reliance on opioids and improving patient outcomes.
What could go wrong
This is a small pilot study focused on feasibility, not proof of effectiveness. Results may not generalize, and the intervention may not be practical in busy ERs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

86 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Musculoskeletal Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Musculoskeletal pain

Contacts and locations

Locations

  • Duke University Hospital Emergency Department

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.