Low Back PainLBPNCT03748849
Pain Sensory Profile Changes Following Treatment of Chronic Low Back Pain
An observational study of Low Back Pain, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2016to 7 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Health Science and Technology
Aalborg, North Denmark, 9220
About this study
Official title: Is the Subjective Experience of Recovery From Low Back Pain Related a Decrease in the Sensitivity of Pain Mechanisms?
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
Read the 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:
- 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
- Conditions
- Low Back Pain
- Being tested
- Physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Secondary outcomes (2)
Pain (measured on a numeric rating scale)
Change in pain between baseline and follow-up measured on a numeric rating scale (0 = no pain and 10 = worst pain imaginable)
Measured: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Disability measured on the Roland-Morris Disability Questionnaire
Change in disability between baseline and follow-up will be found by comparing baseline measurements with measurements at discharge
Measured: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start20 Jan 2016
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorvaldur Skuli Palsson, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748849
- Sponsor's protocol ID
- N-20150048
- Acronym
- LBP
- Status last verified
- May 2020
- First submitted
- 12 Nov 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Subjective Experience of Recovery From Low Back Pain Related a Decrease in the Sensitivity of Pain Mechanisms?
- ClinicalTrials.gov ID
- NCT03748849
- Acronym / sponsor ID
- LBP / N-20150048
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain group | – | Procedure: PhysiotherapyMales 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. |
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy | Procedure or surgery | Low back pain group |
Primary outcome
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.
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
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)
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.
2 secondary outcomes
Pain (measured on a numeric rating scale)
Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Disability measured on the Roland-Morris Disability Questionnaire
Time frame: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.