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NCT Number: NCT06544525

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

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.

Recruiting

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

The intervention will be physical therapy standard of care.

Primary outcomes

  1. 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

  1. Central Sensitization Inventory

    Time frame: From enrollment until study end at 6 weeks.

    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.

  2. Conditioned pain modulation

    Time frame: From enrollment until study end at 6 weeks.

    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.

  3. Temporal Summation

    Time frame: From enrollment until study end at 6 weeks.

    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.

  4. Numeric pain rating scale

    Time frame: From enrollment until study end (6 weeks).

    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.

  5. Global rating of change scale

    Time frame: From enrollment until end of study (6 weeks)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle R Petrey, DPT

CONTACT

[email protected]

8472742794

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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