Recruiting

Observational Study

Sponsor:

Brooke Army Medical Center

Code:

NCT06544525

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Physical therapy

Study Details

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.

Conditions

Low Back Pain

Study ID

NCT06544525

Start date

Sep 19, 2024

Status verified date

Apr, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

57 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: chronic low back pain

Age 18-64 years with low back pain duration greater than 3 months.

Interventions

Physical therapy

The intervention will be physical therapy standard of care.

Primary outcome measure

  • Modified Oswestry Disability Index [ Time Frame: From enrollment until end of study at 6 weeks. ]

Central Contacts and Locations

Central contacts

Locations

Brooke Army Medical Center

Recruiting

Ft Sam Houston, Texas, United States, 78234

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Apr 23, 2025

Last verified

Apr, 2025

Keywords

  • low back pain
  • physical therapy
  • conditioned pain modulation
  • temporal summation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2025-04-23.