An interventional study of Physical therapy in Low Back Pain, sponsored by Brooke Army Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 57 is close to the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Brooke Army Medical Center is the lead sponsor of 94 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Exclusion Criteria:
Age 18-64 years with low back pain duration greater than 3 months.
Other: Physical therapy
The intervention will be physical therapy standard of care.
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).
Time frame: From enrollment until end of study at 6 weeks.
Central Sensitization Inventory
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.
Time frame: From enrollment until study end at 6 weeks.
Conditioned pain modulation
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.
Time frame: From enrollment until study end at 6 weeks.
Temporal Summation
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.
Time frame: From enrollment until study end at 6 weeks.
Numeric pain rating scale
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.
Time frame: From enrollment until study end (6 weeks).
Global rating of change scale
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).
Time frame: From enrollment until end of study (6 weeks)
Plan to share: Yes — Requests for deidentified data will be considered on a case by case basis.
Supporting information: 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.
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Brooke Army Medical Center