Clinical trial NCT06544525: Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?
Official title: Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
physical therapy
conditioned pain modulation
temporal summation
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2024-08-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will be a quasi-experimental, one-group repeated measures design.
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: From enrollment until end of study at 6 weeks.
Secondary outcomes:
measure: Central Sensitization Inventory
timeFrame: From enrollment until study end at 6 weeks.
measure: Conditioned pain modulation
timeFrame: From enrollment until study end at 6 weeks.
measure: Temporal Summation
timeFrame: From enrollment until study end at 6 weeks.
measure: Numeric pain rating scale
timeFrame: From enrollment until study end (6 weeks).
measure: Global rating of change scale
timeFrame: From enrollment until end of study (6 weeks)
Other outcomes:
Locations:
city: Ft Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC
name: Kyle Petrey, DPT
role: PRINCIPAL_INVESTIGATOR
References: