Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical therapy.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Physical therapy
The intervention will be physical therapy standard of care.
Primary outcome measures
- Modified Oswestry Disability Index [Time frame: From enrollment until end of study at 6 weeks.]
Secondary outcome measures (5)
- Central Sensitization Inventory [Time frame: From enrollment until study end at 6 weeks.]
- Conditioned pain modulation [Time frame: From enrollment until study end at 6 weeks.]
- Temporal Summation [Time frame: From enrollment until study end at 6 weeks.]
- Numeric pain rating scale [Time frame: From enrollment until study end (6 weeks).]
- Global rating of change scale [Time frame: From enrollment until end of study (6 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brooke Army Medical Center — Fort Sam Houston
Identifiers
NCT: NCT06544525 · C.2024.070