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Completed

NCT Number: NCT03748849

Pain Sensory Profile Changes Following Treatment of Chronic Low Back Pain

Several cross-sectional studies have demonstrated that patients with chronic low back pain have higher levels of pain sensitivity (local and widespread) when compared to controls. It is unclear however, if improvements in pain and function are reflected in a decrease in the sensitivity of pain mechanisms. This study compares the pain sensory profile in patients with chronic low back pain before and after a period of physiotherapy treatment. To account for natural fluctuations in pain sensitivity, healthy age matched controls are also measured twice

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Health Science and Technology

Aalborg, North Denmark, 9220, Denmark

About this study

The sensitivity of pain mechanisms has consistently been shown to be increased in people suffering from chronic low back pain. This includes both sensitivity in the painful region but also in areas distant indicating widespread pain sensitivity. It is less clear whether this is normalized following a successful treatment intervention.

This study is recruiting people with low back pain and healthy, age matched controls. At baseline, the following measurements are made:

  • the sensitivity to pressure (at the low back and at the shoulder)
  • the pain detection threshold and pain tolerance threshold at the lower legs
  • the temporal summation of pain
  • conditioned pain modulation
  • Fear-avoidance beliefs
  • Disability (Roland-Morris Disability Questionnaire)
  • The Orebro musculoskeletal pain questionnaire

During their enrollment, the patients report their weekly pain electronically

All quantitative sensory testing (QST) and questionnaire data are blind to the principal investigator until data collection has been finished

After the baseline measurements, the patients are offered physiotherapy treatment. The treatment protocol (dosage and type of intervention) is designed based on individual needs following an assessment by a musculoskeletal physiotherapist. The number of sessions and time between treatment sessions depend on how the patients respond to the chosen intervention. Patients are discharged from treatment when:

  • they have made sufficient recovery (their back pain is no longer a problem)
  • the chosen intervention(s) have failed to affect their condition
  • no more recovery is expected

The quantitative sensory testing measurements are performed again after discharge

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patient group

  • Pain located in the low back region, defined as the area lying between the posterior superior iliac spine below and the thoracolumbar junction above
  • The pain has lasted between 3 and 60 months

Exclusion criteria

  • Pain related to a specific pathology such as spinal stenosis, metastasis, fracture etc.
  • Leg pain related to nerve root compression/irritation.
  • Multiple painful sites/areas unrelated to the back pain
  • Operation to the spine
  • Any neurological or systemic diseases which can affect the outcome measures
  • Pregnancy
  • Lack of ability to cooperate

Control group Inclusion Criteria

  • Are healthy and free from any pain specific to the low back and/or in general

Exclusion criteria

  • No current or previous history of on-going pain, defined as pain lasting more than 3 months, in the lumbopelvic region and/or elsewhere
  • Have participated in studies using a similar experimental pain model

Treatment and study plan

physiotherapy

Procedure

Primary outcomes

  1. Change in cuff-pressure mechanical sensitivity, measured with a computer-controlled pressure cuff

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    The pressure needed to evoke first onset of pain (pain detection threshold, PDT) and the most pressure tolerable (pain tolerance threshold, PTT) are measured with a computer controlled pressure cuff. The cuff is placed on the lower leg and is gradually inflated (1kPa/sec). The first onset of pain (VAS 1, measured on an electronic VAS scale: 0=no pain, 10=worst pain imaginable) is indicated when the sensation of pressure around the leg changes to pain. The pressure continues to rise until the PTT is reached. PTT is defined as the point where the subject cannot endure more increase in pressure.

  2. Sensitivity to mechanical point pressure measured with a handheld pressure algometer

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    Change in sensitivity to mechanical point pressure back (L5 and L1) and shoulder (infraspinatus) between baseline and discharge from rehabilitation.

    Mechanical point pressure is measured with a handheld pressure algometer (Somedic, Sweden). The average from dominant and non-dominant sides will be used for analysis

  3. Temporal summation of pain (increase in pain from repeated nociceptive stimuli at the same intensity) measured with a computer-controlled pressure cuff

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    Change in temporal summation of pain between baseline and follow-up. Temporal summation of pain is assessed by using a computer controlled pressure cuff which is mounted on the lower leg on the dominant side. The participant receives 10 stimuli with a 1sec break between stimuli. Immediately following each stimuli, the participants rates the pain intensity using an electronic VAS scale (0-10, where 0=no pain and 10=worst pain imaginable)

  4. Conditioned pain modulation (change in pain sensitivity following the onset of a competing, nociceptive stimulus) measured with a computer-controlled pressure cuff

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    Change in conditioned pain modulation between baseline and follow-up. Conditioned pain modulation is assessed by using two computer controlled pressure cuffs which are mounted on the lower legs, one on each side. On the non-dominant side, the cuff is inflated rapidly up to 80% of the pain tolerance threshold and kept there steady. In the meanwhile, the pain detection threshold and pain tolerance thresholds are assessed on the dominant side. Changes in PDT and PTT compared with baseline are defined as a CPM response.

Secondary outcomes

  1. Pain (measured on a numeric rating scale)

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    Change in pain between baseline and follow-up measured on a numeric rating scale (0 = no pain and 10 = worst pain imaginable)

  2. Disability measured on the Roland-Morris Disability Questionnaire

    Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)

    Change in disability between baseline and follow-up will be found by comparing baseline measurements with measurements at discharge

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Is the Subjective Experience of Recovery From Low Back Pain Related a Decrease in the Sensitivity of Pain Mechanisms?

Acronym: LBP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2018
Registry last updated
May 13, 2020

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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