Pain Sensory Profile Changes Following Treatment of Chronic Low Back Pain

NCT03748849 | Completed

• 1 other identifier: N-20150048
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

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

  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.

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

• Sensitivity to mechanical point pressure measured with a handheld pressure algometer

  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

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

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

  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)

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

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

  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.

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

Secondary Outcomes (2)

• Pain (measured on a numeric rating scale)

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

• Disability measured on the Roland-Morris Disability Questionnaire

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

Study Arms (2)

Low back pain group

Males and females who have had low back pain lasting between 12 weeks - 5 years without any other health problems (physical or psychological). Following baseline measurements, all subjects are offered individualized physiotherapy. The interventions mainly consist of exercises targeting their functional limitations. These are supplemented by a thorough explanation of their pain condition. This is done within the boundaries of the current understanding of musculoskeletal pain. This is supplemented with encouragement to do regular exercise and with manual therapy if needed/indicated.

Procedure: Physiotherapy

Control group

Healthy males and females who have no current musculoskeletal pain problem (specific to the low back and/or in general). Likewise, they cannot have a previous history of on-going musculoskeletal pain. On-going pain is defined as a condition that limited their function for 3 months or more. Participants in the control group take part in the baseline measurement and then another measurement after 6-8 weeks

Interventions

Physiotherapy PROCEDURE

Low back pain group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Low back pain group Males and females who have had low back pain lasting 3 - 60 months. The reason for onset (traumatic/non-traumatic) is registered but not used for inclusion/exclusion Control group Healthy males and females with no current or previous history of musculoskeletal pain. Previous history is defined as pain of on-going nature (lasting 3 months or more) in the low back and/or in general

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Department of Health Science and Technology

Aalborg, North Denmark, 9220, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 21, 2018
• Study Start: January 20, 2016
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)