Low Back PainNCT04770480
Non-pharmacological Treatment for Pain After Spine Surgery
A study testing Enriched Pain Management Pathway (EPM) in people with Low Back Pain and Chronic Pain, run by Dan Rhon at 3 sites in United States.
Trial summary
This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Chronic Pain, Surgery
- What is being tested?
- Enriched Pain Management Pathway (EPM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Dec 2021to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tricare beneficiary receiving care in a participating MHS facility.
- Age 18 - 75 years at the time of enrollment
- 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
- Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
- 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
Who cannot join
- Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
- A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
- Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
- 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.
- Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Brooke Army Medical Center
San Antonio, Texas, 78234
Madigan Army Medical Center
Tacoma, Washington, 98391
About this study
Official title: Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial
This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.
Read the detailed description
The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastrophic thinking, especially if patients have unrealistic recovery expectations that go unmet. Physical therapy (PT) can improve chronic LBP (low back pain) outcomes, with effects mediated through changes in pain catastrophizing and self-efficacy. Mindfulness techniques help patients disentangle an experience (e.g., pain) from associated emotions and appraisals. Mindfulness can enhance emotion regulation and raise un-conscious behavioral responses (e.g., opioid use) to conscious consideration. The benefits of mindfulness for chronic pain are mediated by changes in hypervigilance and self-efficacy. Physical therapy and mindfulness can disrupt the self-reinforcing cycle of pain, catastrophic appraisal and unconscious behavioral response including opioid use. Our project examines an innovative strategy to integrate mindfulness and PT into an enriched surgical management pathway for individuals undergoing lumbar spine surgery.
Patients at 3 different military hospitals will be randomized prior to surgery to two different treatment groups and followed for a period of 6 months, including the post-operative intervention phase.
- Being tested
- Standard Care (SC), Enriched Pain Management Pathway (EPM)
- Keywords
- chronic pain, low back pain, spine surgery, non-pharmacological treatment, mindfulness, physical therapy
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care (SC)Behavioural
No attempt will be made to change usual care practice after surgery
Enriched Pain Management Pathway (EPM)Behavioural
Enriched Pain Management Pathway will be delivered by physical therapists trained to integrate physical therapy and mindfulness techniques grounded in a biopsychosocial context. The intervention will be delivered within the context of the post-operative physical therapy routine (the mindfulness approach will be integrated into the post-operative physical therapy care).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (SC) | Active comparator | Standard Post-Surgical Care utilizing opioids. Receives: Behavioral: Standard Care (SC) |
| Enriched Surgical Management Pathway (EMP) | Active comparator | Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol. Receives: Behavioral: Enriched Pain Management Pathway (EPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Enjoyment, and General Activity Scale (PEG-3)
The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Response options for each item range from 0-10 with higher scores indicating higher pain intensity. The PEG-3 score is expressed as the mean of all item scores.
Measured: 6 Months
Secondary outcomes (1)
Time to Discontinuation of Opioids After Surgery
The length of time (recorded in days) until a patient discontinues pain medications after surgery.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Dec 2021
- Primary completion29 Nov 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Model description
- Primary Outcome: The primary analysis will be performed by fitting a longitudinal linear model to the PEG scores at baseline, 2 weeks and 26 weeks. Secondary Outcome: Kaplan Meier curves with 95% pointwise confidence limits will be constructed to summarize the time to opioid discontinuation in each of the EPM and SC treatment groups. Time to opioid discontinuation will be compared between groups using a stratified log-rank test, with stratification for three randomization stratification factors.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Rhon
- Sponsor type
- US federal agency
- Collaborators
- University of Utah, Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, National Center for Complementary and Integrative Health (NCCIH), Brooke Army Medical Center
- Responsible party
- Sponsor-investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Julie M Fritz, PhD, Principal investigator, University of UtahDaniel I Rhon, DSc, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770480
- Sponsor's protocol ID
- eIRB
- Other IDs
- 3UH3AT009763-04S1
- Status last verified
- May 2026
- First submitted
- 22 Feb 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial data from this trial will be entered into the National Institutes of Health Help End Addiction Long-Term (HEAL)Back Pain Consortium (BACPAC) data repository and coordinating center.
Publications
Deyo RA, Hallvik SE, Hildebran C, Marino M, O'Kane N, Carson J, Van Otterloo J, Wright DA, Millet LM, Wakeland W. Use of prescription opioids before and after an operation for chronic pain (lumbar fusion surgery). Pain. 2018 Jun;159(6):1147-1154. doi: 10.1097/j.pain.0000000000001202.
PubMed 29521813Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.
PubMed 17119140Ong KL, Stoner KE, Yun BM, Lau E, Edidin AA. Baseline and postfusion opioid burden for patients with low back pain. Am J Manag Care. 2018 Aug 1;24(8):e234-e240.
PubMed 30130023Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain. 2007 Oct;11(7):711-8. doi: 10.1016/j.ejpain.2006.10.009. Epub 2007 Jan 10.
PubMed 17218132Morasco BJ, Yarborough BJ, Smith NX, Dobscha SK, Deyo RA, Perrin NA, Green CA. Higher Prescription Opioid Dose is Associated With Worse Patient-Reported Pain Outcomes and More Health Care Utilization. J Pain. 2017 Apr;18(4):437-445. doi: 10.1016/j.jpain.2016.12.004. Epub 2016 Dec 18.
PubMed 27993558Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.
PubMed 26461996Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
PubMed 29489568Lo YT, Lim-Watson M, Seo Y, Fluetsch N, Alasmari MM, Alsheikh MY, Lamba N, Smith TR, Aglio LS, Mekary RA. Long-Term Opioid Prescriptions After Spine Surgery: A Meta-Analysis of Prevalence and Risk Factors. World Neurosurg. 2020 Sep;141:e894-e920. doi: 10.1016/j.wneu.2020.06.081. Epub 2020 Jun 19.
PubMed 32569762Siglin J, Sorkin JD, Namiranian K. Incidence of Postoperative Opioid Overdose and New Diagnosis of Opioid Use Disorder Among US Veterans. Am J Addict. 2020 Jul;29(4):295-304. doi: 10.1111/ajad.13022. Epub 2020 Mar 22.
PubMed 32202000Schoenfeld AJ, Belmont PJ Jr, Blucher JA, Jiang W, Chaudhary MA, Koehlmoos T, Kang JD, Haider AH. Sustained Preoperative Opioid Use Is a Predictor of Continued Use Following Spine Surgery. J Bone Joint Surg Am. 2018 Jun 6;100(11):914-921. doi: 10.2106/JBJS.17.00862.
PubMed 29870441
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04770480
- Acronym / sponsor ID
- eIRB
- Keywords
- chronic pain, low back pain, spine surgery, non-pharmacological treatment, mindfulness, physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Dan RhonUS federal agency
- Collaborators
- University of Utah, Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, National Center for Complementary and Integrative Health (NCCIH), Brooke Army Medical Center
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 25 Feb 2021 (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.
This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.
Detailed description
The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastrophic thinking, especially if patients have unrealistic recovery expectations that go unmet. Physical therapy (PT) can improve chronic LBP (low back pain) outcomes, with effects mediated through changes in pain catastrophizing and self-efficacy. Mindfulness techniques help patients disentangle an experience (e.g., pain) from associated emotions and appraisals. Mindfulness can enhance emotion regulation and raise un-conscious behavioral responses (e.g., opioid use) to conscious consideration. The benefits of mindfulness for chronic pain are mediated by changes in hypervigilance and self-efficacy. Physical therapy and mindfulness can disrupt the self-reinforcing cycle of pain, catastrophic appraisal and unconscious behavioral response including opioid use. Our project examines an innovative strategy to integrate mindfulness and PT into an enriched surgical management pathway for individuals undergoing lumbar spine surgery.
Patients at 3 different military hospitals will be randomized prior to surgery to two different treatment groups and followed for a period of 6 months, including the post-operative intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Primary Outcome: The primary analysis will be performed by fitting a longitudinal linear model to the PEG scores at baseline, 2 weeks and 26 weeks. Secondary Outcome: Kaplan Meier curves with 95% pointwise confidence limits will be constructed to summarize the time to opioid discontinuation in each of the EPM and SC treatment groups. Time to opioid discontinuation will be compared between groups using a stratified log-rank test, with stratification for three randomization stratification factors.
| Arm | Type | Receives |
|---|---|---|
| Standard Care (SC) | Active comparator | Behavioral: Standard Care (SC)Standard Post-Surgical Care utilizing opioids. |
| Enriched Surgical Management Pathway (EMP) | Active comparator | Behavioral: Enriched Pain Management Pathway (EPM)Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tricare beneficiary receiving care in a participating MHS facility.
- Age 18 - 75 years at the time of enrollment
- 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
- Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
- 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
Key exclusion criteria (5 listed)
- Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
- A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
- Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
- 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.
- Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
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 |
|---|---|---|
| Standard Care (SC)No attempt will be made to change usual care practice after surgery | Behavioural | Standard Care (SC) |
| Enriched Pain Management Pathway (EPM)Enriched Pain Management Pathway will be delivered by physical therapists trained to integrate physical therapy and mindfulness techniques grounded in a biopsychosocial context. The intervention will be delivered within the context of the post-operative physical therapy routine (the mindfulness approach will be integrated into the post-operative physical therapy care). | Behavioural | Enriched Surgical Management Pathway (EMP) |
Primary outcome
Pain, Enjoyment, and General Activity Scale (PEG-3)
Time frame: 6 Months
The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Response options for each item range from 0-10 with higher scores indicating higher pain intensity. The PEG-3 score is expressed as the mean of all item scores.
1 secondary outcome
Time to Discontinuation of Opioids After Surgery
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 29521813Deyo RA, Hallvik SE, Hildebran C, Marino M, O'Kane N, Carson J, Van Otterloo J, Wright DA, Millet LM, Wakeland W. Use of prescription opioids before and after an operation for chronic pain (lumbar fusion surgery). Pain. 2018 Jun;159(6):1147-1154. doi: 10.1097/j.pain.0000000000001202.
- Background: PubMed 17119140Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.
- Background: PubMed 30130023Ong KL, Stoner KE, Yun BM, Lau E, Edidin AA. Baseline and postfusion opioid burden for patients with low back pain. Am J Manag Care. 2018 Aug 1;24(8):e234-e240.
- Background: PubMed 17218132Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain. 2007 Oct;11(7):711-8. doi: 10.1016/j.ejpain.2006.10.009. Epub 2007 Jan 10.
- Background: PubMed 27993558Morasco BJ, Yarborough BJ, Smith NX, Dobscha SK, Deyo RA, Perrin NA, Green CA. Higher Prescription Opioid Dose is Associated With Worse Patient-Reported Pain Outcomes and More Health Care Utilization. J Pain. 2017 Apr;18(4):437-445. doi: 10.1016/j.jpain.2016.12.004. Epub 2016 Dec 18.
- Background: PubMed 26461996Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.
- Background: PubMed 29489568Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
- Background: PubMed 32569762Lo YT, Lim-Watson M, Seo Y, Fluetsch N, Alasmari MM, Alsheikh MY, Lamba N, Smith TR, Aglio LS, Mekary RA. Long-Term Opioid Prescriptions After Spine Surgery: A Meta-Analysis of Prevalence and Risk Factors. World Neurosurg. 2020 Sep;141:e894-e920. doi: 10.1016/j.wneu.2020.06.081. Epub 2020 Jun 19.
- Background: PubMed 32202000Siglin J, Sorkin JD, Namiranian K. Incidence of Postoperative Opioid Overdose and New Diagnosis of Opioid Use Disorder Among US Veterans. Am J Addict. 2020 Jul;29(4):295-304. doi: 10.1111/ajad.13022. Epub 2020 Mar 22.
- Background: PubMed 29870441Schoenfeld AJ, Belmont PJ Jr, Blucher JA, Jiang W, Chaudhary MA, Koehlmoos T, Kang JD, Haider AH. Sustained Preoperative Opioid Use Is a Predictor of Continued Use Following Spine Surgery. J Bone Joint Surg Am. 2018 Jun 6;100(11):914-921. doi: 10.2106/JBJS.17.00862.
- HEAL BACPACLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Trial data from this trial will be entered into the National Institutes of Health Help End Addiction Long-Term (HEAL)Back Pain Consortium (BACPAC) data repository and coordinating center.
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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.
Julie M Fritz, PhD principal investigator
University of Utah
Daniel I Rhon, DSc principal investigator
Brooke Army Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Pain Management Pathway (EPM) in people with Low Back Pain and Chronic Pain, run by Dan Rhon at 3 sites 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain, Enjoyment, and General Activity Scale (PEG-3) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770480, which also lists 10 linked publications.
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 May 2026.