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New study tests drug-free pain relief after back surgery to cut opioid use

NCT ID NCT04770480

Symptom relief Sponsor: Dan Rhon 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two different ways to manage pain after lower back surgery without relying on drugs. About 267 adults will be randomly assigned to either standard care or an enriched pain management plan. The goal is to see which approach better reduces pain and helps people stop taking opioids sooner.

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

267 people

The number who actually took part.

Started

Dec 2021

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Tricare beneficiary receiving care in a participating MHS facility. 2. Age 18 - 75 years at the time of enrollment 3. Scheduled to undergo lumbar spine surgery within the next 60 days. Surgery may be laminectomy with or without fusions including lateral, transforaminal, posterior or anterior approach for 1-4 lumbar levels. Surgery may be performed in military or civilian facility 4. Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis. 5. Anticipates ability to attend treatment sessions over a 16 week period following the surgical procedure with no planned absence of 2 weeks or more for training, vacation or any purpose Exclusion Criteria: 1. Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery. 2. A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy 3. Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year. 4. Contra-indication to participation in post-operative exercise program including severe orthopedic injury limiting mobility, wheelchair dependency, neurological disorder impacting mobility, reliance on supplemental oxygen for daily activity, etc. 5. Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome Low Back Pain lumbar disk degenerative disorder lumbar disk herniation, susceptibility to lumbar spinal stenosis scoliosis spondylolisthesis spondylosis

As listed by the trial registrant

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

Back pain lower back chronic Back pain, low Chronic pain Low back pain Surgery

Contacts and locations

Locations

  • Brooke Army Medical Center

    San Antonio, Texas, 78234, United States

  • Madigan Army Medical Center

    Tacoma, Washington, 98391, United States

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859, United States

More trials for these conditions

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