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

NCT06544525 | Recruiting

• 1 other identifier: C.2024.070
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Modified Oswestry Disability Index

  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).

  From enrollment until end of study at 6 weeks.

Secondary Outcomes (5)

• Central Sensitization Inventory

  From enrollment until study end at 6 weeks.

• Conditioned pain modulation

  From enrollment until study end at 6 weeks.

• Temporal Summation

  From enrollment until study end at 6 weeks.

• Numeric pain rating scale

  From enrollment until study end (6 weeks).

• Global rating of change scale

  From enrollment until end of study (6 weeks)

Study Arms (1)

chronic low back pain

EXPERIMENTAL

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

Other: Physical therapy

Interventions

Physical therapy OTHER

The intervention will be physical therapy standard of care.

chronic low back pain

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Kyle Petrey, DPT

  BAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle R Petrey, DPT

CONTACT

8472742794; kyle.r.petrey.mil@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic and Manual Physical Therapy Fellow

Model Details: This study will be a quasi-experimental, one-group repeated measures design.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 19, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Requests for deidentified data will be considered on a case by case basis.
• Access Criteria: Requests for deidentified data will be considered on a case by case basis.

Locations

US (1)