Pain Sensory Profile Changes Following Treatment of Chronic Low Back Pain

NCT ID: NCT03748849

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2019-01-07

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

Detailed Description

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:

1. they have made sufficient recovery (their back pain is no longer a problem)

2. the chosen intervention(s) have failed to affect their condition

3. no more recovery is expected

The quantitative sensory testing measurements are performed again after discharge

Conditions

Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Physiotherapy

Intervention Type: PROCEDURE

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

No interventions assigned to this group

Interventions

Physiotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Thorvaldur Skuli Palsson

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Health Science and Technology

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20150048

Identifier Type: -

Identifier Source: org_study_id