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NCT Number: NCT04193969

Changes in Radicular Pain and Pain Modulation

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.

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Key information

Conditions

Back Pain Back Pain With Radiation Low Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure pain assessment using computer controlled cuff algometry

Diagnostic Test

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.

Other names: Assessment of pain sensitivity

Temporal summation (TS)

Diagnostic Test

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.

Other names: Repeated pressure pain

Conditioned pain modulation (CPM)

Diagnostic Test

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.

Other names: Pain inhibition

Low back pain rating scale (LBPRS-pain)

Diagnostic Test

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.

Other names: Pain intensity

Oswestry Disability Index

Diagnostic Test

A questionnaire measuring the disability in relation to low back pain and leg pain.

Other names: Disability

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Leg pain (measured on the low back pain rating scale)

    Time frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.

    Change in pain between post-treatment and pre-treatment. The average pain during the last two weeks, the worst pain experienced during the same period and current pain is rated by the patient. Range 0-30. 0=no pain, 30= Worst pain imaginable.

  2. Back pain and leg pain (measured on the low back pain rating scale)

    Time frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.

    Change in pain between post-treatment and pre-treatment. Low back pain rating scale (LBPRS - pain): Two questionnaires with three numeric 11-point box scales (0-10) regarding low back pain and leg pain respectively. The average pain during the last two weeks, the worst pain experienced during the same period and current pain is rated by the patient. Range 0-60. 0=no pain, 60= Worst pain imaginable.

  3. Disability (Measured on the Oswestry Disability index)

    Time frame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.

    Change in disability between post-treatment and pretreatment. Range 0-100, 0= No disability, 100 maximum disability possible.

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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