Changes in Radicular Pain and Pain Modulation

Spine Centre of Southern Denmark

Status: Completed

Conditions: Back Pain; Back Pain With Radiation

Treatments: Diagnostic Test: Conditioned pain modulation (CPM); Diagnostic Test: Pressure pain assessment using computer controlled cuff algometry; Diagnostic Test: Oswestry Disability Index; Diagnostic Test: Low back pain rating scale (LBPRS-pain); Diagnostic Test: Temporal summation (TS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04193969

S-20190091

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Radiculopathy due to nerve root compression

Experimental group

Description:

Participants with radicular leg pain due to lumbar disc herniation or to foraminal- or recess stenosis. Baseline assessments of pain intensities are performed through questionnaires prior to protocol. Data regarding initial pain, function, age, gender, pain-duration, weight and height is retrieved from the clinical registry SpineData. Pain sensitivity, temporal summation and conditioned pain modulation are assessed at the first visit in the treatment program. The protocol is repeated at the last visit in the treatment program.

Treatment:

Diagnostic Test: Oswestry Disability Index

Diagnostic Test: Low back pain rating scale (LBPRS-pain)

Diagnostic Test: Temporal summation (TS)

Diagnostic Test: Pressure pain assessment using computer controlled cuff algometry

Diagnostic Test: Conditioned pain modulation (CPM)

Healthy controls

Experimental group

Description:

Healthy controls Healthy age and gender-matched controls. Gender, weight and height are registered on questionnaires prior to protocol. Pain sensitivity, temporal summation and conditioned pain modulation are assessed at the first visit. The tests are repeated at the next visit. The interval between the two sessions will be determined by the averaged interval between tests in the patient group.

Treatment:

Diagnostic Test: Temporal summation (TS)

Diagnostic Test: Pressure pain assessment using computer controlled cuff algometry

Diagnostic Test: Conditioned pain modulation (CPM)