The Association Between Changes in Radicular Pain and Pain Modulation Among Patients With Lumbar Radiculopathy: A Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain
- Sponsor
- Spine Centre of Southern Denmark
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Conditioned pain modulation (change in pain sensitivity during a competing pain stimulus) measured with computer-controlled cuff algometry
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objectives of this study are: 1)To investigate the difference in pain modulatory mechanisms using quantitative sensory testing (QST) between healthy controls and patients with radicular leg pain due to nerve root compression. 2) To investigate the association between changes in radiating leg pain and pain modulation among the patient group.
Detailed Description
Few studies have investigated pain modulatory mechanisms using QST in patients with lumbar radiculopathy due to nerve root compression. Knowledge about the association between changes in the experience of pain and changes measures of pain modulation is to our knowledge limited. The results could potentially contribute to knowledge about mechanisms involved in lumbar radiculopathy and facilitate future studies. The hypotheses of the study are: 1) Measures of pain modulation will be less efficient among patients with lumbar radiculopathy showing reduced pain inhibition and facilitated temporal summation compared to healthy controls. 2) Improvements in pain modulation will be associated with improvements in clinical pain outcomes
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient group
- •Radiating leg pain due to nerve root compression verified by MRI
- •Clinical findings in accordance with MRI findings
- •Average leg pain ≥ 3/10 on a numeric pain rating scale Controls
- •No current or previous history of ongoing musculoskeletal pain
Exclusion Criteria
- •Applies for both groups.
- •Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular diseases.
- •Pregnancy
Outcomes
Primary Outcomes
Conditioned pain modulation (change in pain sensitivity during a competing pain stimulus) measured with computer-controlled cuff algometry
Time Frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
Change in pain intensity between baseline and follow-up. Cuff is placed on the lower leg. In patients the non-painful leg is used, in healthy controls, half of the participants will be tested on the left leg and half on the right leg. 10 painful stimuli are performed with a one-second interval in between. After each stimulus, the participant rates the pain intensities using an electronic VAS ( 0=No pain, 10=worst pain imaginable pain). The increase in pain intensity is defined as temporal summation.
Cuff sensitivity, measured with computer-controlled cuff algometry
Time Frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
Change in pain sensitivity between baseline and follow-up. Cuff is placed around the lower leg and on the upper arm and gradually inflated (1kPa/sec) on each location separately. In patients, the cuff is placed on the non-painful leg and left upper arm, in healthy controls, half of the participants the cuff is placed on the left leg and half on the right leg, while the other cuff is placed on the left upper arm. First, the pressure needed to evoke an onset of pain (pain detection threshold, PDT), the pressure at pain intensity VAS 6 (Measured on an electronic visual analogue scale: 0=No pain, 10=worst pain imaginable pain) and pain tolerance threshold (PTT) is assessed on the lower leg. Secondly, the PDT and the PTT is assessed on the left upper arm.
Temporal summation of pain (increase in pain during repeated pain stimuli at same intensity) measured with computer-controlled cuff algometry
Time Frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
Change in pain intensity between baseline and follow-up. Cuff is placed on the lower leg. In patients the non-painful leg is used, in healthy controls, half of the participants will be tested on the left leg and half on the right leg. 10 painful stimuli are performed with a one-second interval in between. After each stimulus, the participant rates the pain intensities using an electronic VAS ( 0=No pain, 10=worst pain imaginable pain). The increase in pain intensity is defined as temporal summation.
Secondary Outcomes
- Leg pain (measured on the low back pain rating scale)(At baseline and at discharge from treatment throughout study completion, an average of 6 months.)
- Back pain and leg pain (measured on the low back pain rating scale)(At baseline and at discharge from treatment throughout study completion, an average of 6 months.)
- Disability (Measured on the Oswestry Disability index)(At baseline and at discharge from treatment throughout study completion, an average of 6 months.)