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

NCT ID: NCT06544525

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2025-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chronic low back pain

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

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: OTHER

The intervention will be physical therapy standard of care.

Interventions

Physical therapy

The intervention will be physical therapy standard of care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Kyle R. Petrey

Orthopedic and Manual Physical Therapy Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Petrey, DPT

Role: PRINCIPAL_INVESTIGATOR

BAMC

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kyle R Petrey, DPT

Role: CONTACT

kyle.r.petrey.mil@health.mil

8472742794

Other Identifiers

C.2024.070

Identifier Type: -

Identifier Source: org_study_id