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Clinical Trials/NCT06544525
NCT06544525
Recruiting
Not Applicable

Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?

Brooke Army Medical Center1 site in 1 country57 target enrollmentSeptember 19, 2024
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Brooke Army Medical Center
Enrollment
57
Locations
1
Primary Endpoint
Modified Oswestry Disability Index
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2024
End Date
July 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kyle R. Petrey

Orthopedic and Manual Physical Therapy Fellow

Brooke Army Medical Center

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Central Sensitization Inventory(From enrollment until study end at 6 weeks.)
  • Numeric pain rating scale(From enrollment until study end (6 weeks).)
  • Temporal Summation(From enrollment until study end at 6 weeks.)
  • Conditioned pain modulation(From enrollment until study end at 6 weeks.)
  • Global rating of change scale(From enrollment until end of study (6 weeks))

Study Sites (1)

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