Low Back PainNCT06544525
Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?
A study testing Physical therapy in people with Low Back Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to Jul 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS eligible
- English speaking
- Age 18-64 years
- ODI baseline ≥25%
- NPRS baseline ≥3/10
- Low back pain symptoms greater than 3 months
- Must be able to commit to at least six weeks of physical therapy interventions
Who cannot join
- Serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy)
- Low back pain symptoms radiating below the knee
- Pregnancy
- Diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia.
- History spinal surgery
- Currently under litigation related to low back pain
- Currently going through Medical Evaluation Board (MEB)
- Retiring or separating from the military within a year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.
- Conditions
- Low Back Pain
- Being tested
- Physical therapy
- Keywords
- low back pain, physical therapy, conditioned pain modulation, temporal summation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
The intervention will be physical therapy standard of care.
| Study group | Role | What they receive |
|---|---|---|
| chronic low back pain | Experimental | Age 18-64 years with low back pain duration greater than 3 months. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry Disability Index
The ODI will be the primary outcome for this study. The ODI contains 10 items that assess function and disability (0 = no disability, 100 = maximal disability).
Measured: From enrollment until end of study at 6 weeks.
Secondary outcomes (5)
Central Sensitization Inventory
The CSI is a 25-item questionnaire that assesses symptoms common to central sensitization syndromes using a 0-100-point scale, in which 100 indicates a higher level of symptoms common to central sensitization.
Measured: From enrollment until study end at 6 weeks.
Conditioned pain modulation
CPM calculation: It is recommended that CPM response be reported as an absolute value and percent change. The calculation for absolute value is: CPM = PPTpre -PPTconditioning. PPTpre is the testing stimulus conducted before conditioning stimulus application and PPTconditioning is the testing stimulus conducted during conditioning stimulation. This is expressed in kPa. A negative value suggests that CPM is functioning effectively and indicative of an anti-nociceptive profile, while a positive value suggests CPM is impaired and indicative of a pro-nociceptive profile. The second method will be CPM expressed as percent change of the testing stimulus before and during the application of the conditioning stimulus. The equation for percent change is: [(postPPT - prePPT)/prePPT] * 100. CPM will be expressed as continuous ratio data via absolute value and percent change. The absolute value score will be used for the statistical model and will be collected at baseline and follow up.
Measured: From enrollment until study end at 6 weeks.
Temporal Summation
Temporal summation is calculated as follows: VAS10th - VAS1st. A positive number indicates the magnitude of temporal summation of pain. This will be expressed as continuous ratio data and will be collected at baseline and follow up.
Measured: From enrollment until study end at 6 weeks.
Numeric pain rating scale
The NPRS is an 11-point numerical pain rating scale used to measure pain. Patients rate pain ranging between 0 (no pain) and 10 (worst pain imaginable).
This will be measured as the mean of three pain ratings: best pain rating over 24 hours, worst pain rating over 24 hours, and current pain rating.
Measured: From enrollment until study end (6 weeks).
Global rating of change scale
The GRC utilized in this study is an 11-point scale designed to quantify a patient's improvement or deterioration over time. The GRC will only be completed at discharge (6-weeks).
Measured: From enrollment until end of study (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start19 Sep 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be a quasi-experimental, one-group repeated measures design.
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Kyle R. Petrey, Brooke Army Medical Center
- Investigators
- Kyle Petrey, DPT, Principal investigator, BAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544525
- Sponsor's protocol ID
- C.2024.070
- Status last verified
- Apr 2025
- First submitted
- 6 Aug 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for deidentified data will be considered on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?
- ClinicalTrials.gov ID
- NCT06544525
- Acronym / sponsor ID
- C.2024.070
- Conditions
- Low Back Pain
- Keywords
- low back pain, physical therapy, conditioned pain modulation, temporal summation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be a quasi-experimental, one-group repeated measures design.
| Arm | Type | Receives |
|---|---|---|
| chronic low back pain | Experimental | Other: Physical therapyAge 18-64 years with low back pain duration greater than 3 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DEERS eligible
- English speaking
- Age 18-64 years
- ODI baseline ≥25%
- NPRS baseline ≥3/10
Key exclusion criteria (8 listed)
- Serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy)
- Low back pain symptoms radiating below the knee
- Pregnancy
- Diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia.
- History spinal surgery
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 |
|---|---|---|
| Physical therapyThe intervention will be physical therapy standard of care. | Other | chronic low back pain |
Primary outcome
Modified Oswestry Disability Index
Time frame: From enrollment until end of study at 6 weeks.
The ODI will be the primary outcome for this study. The ODI contains 10 items that assess function and disability (0 = no disability, 100 = maximal disability).
5 secondary outcomes
Central Sensitization Inventory
Time frame: From enrollment until study end at 6 weeks.
Conditioned pain modulation
Time frame: From enrollment until study end at 6 weeks.
Temporal Summation
Time frame: From enrollment until study end at 6 weeks.
Numeric pain rating scale
Time frame: From enrollment until study end (6 weeks).
Global rating of change scale
Time frame: From enrollment until end of study (6 weeks)
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 23 Apr 2025.
- Individual participant dataSharing planned: Yes. Requests for deidentified data will be considered on a case by case basis.
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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.
Kyle Petrey, DPT principal investigator
BAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Low Back Pain, run by Brooke Army Medical Center 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. 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?
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?
Contact Kyle R Petrey, DPT (8472742794, kyle.r.petrey.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oswestry Disability Index (time frame: From enrollment until end of study at 6 weeks.). 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 23 Apr 2025.