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

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBrooke Army Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DEERS eligible

English speaking

Age 18-64 years

ODI baseline ≥25%

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Physical therapy

    Other intervention

    The intervention will be physical therapy standard of care.

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: chronic low back painExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
From enrollment until end of study at 6 weeks.

Secondary outcomes

1

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.
2

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.
3

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.
4

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).

Other outcomes

Sponsors and contacts

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