NCT04193969

Changes in Radicular Pain and Pain Modulation

The Association Between Changes in Radicular Pain and Pain Modulation Among Patients With Lumbar Radiculopathy: A Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Spine Centre of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Back Pain
• Back Pain With Radiation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pressure pain assessment using computer controlled cuff algometry	Pressure pain sensitivity is assessed. The pressure is gradually increased and pain is rated by the participant on an electronic visual analogue pain rating scale (VAS) which is connected to the equipment. The assessment is performed on the lower leg and the upper arm. The pain free leg and the left upper arm is used in the patient group. The leg used in the control group will be chosen in a balanced manner meaning that half will receive pressure on the left leg and the other half on the right leg. The pain detection threshold (PDT), pain pressure tolerance threshold (PPT) and pressure pain intensity perceived as 6 on the VAS (VAS6) at the leg site is registered. The PDT and PPT on the arm site is registered.
DIAGNOSTIC_TEST	Temporal summation (TS)	10 repeated inflations on the lower leg with a 1 sec interval. The pressure used at each pressure is equivalent the PPT measured at baseline. Each inflation is rated on the VAS. TS is registered as the increase pain intensity.
DIAGNOSTIC_TEST	Conditioned pain modulation (CPM)	The cuff on the upper arm is inflated until 70% of the PPT is reached. While the pressure on the arm is kept constant the cuff on the leg is inflated. PDT, PPT and VAS6 pressure at the leg site is registered during the tonic stimulation (pressure on the left arm). The procedure on the leg is repeated within 30 seconds after the pressure is released on the arm site.
DIAGNOSTIC_TEST	Low back pain rating scale (LBPRS-pain)	A questionnaire measuring the intensities of low back pain and leg pain currently, on average the last two weeks and the worst pain within the same period.
DIAGNOSTIC_TEST	Oswestry Disability Index	A questionnaire measuring the disability in relation to low back pain and leg pain.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-07-01
• Completion: 2021-09-21
• First posted: 2019-12-11
• Last updated: 2022-05-09

Locations

1 site across 1 country: Denmark