Chronic Low Back PainNCT03643731
Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.
A study testing HeatTens (HV-F311-E) in people with Chronic Low Back Pain and Movement Evoked Pain, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Low Back Pain, Movement Evoked Pain
- What is being tested?
- HeatTens (HV-F311-E)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Aug 2018to 9 Aug 2019
- Phase
- Interventional
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).
Who cannot join
- spinal surgery in the past 6 months
- severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),
- pregnant or given birth in the preceding year,
- having initiated a new LBP treatment in the 6 weeks prior to study participation
Trial locations and contacts
1 site in 1 country.
About this study
A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Following baseline measurements, subjects will be randomly allocated to the experimental or the control group. The experimental group will be asked to use the device on a daily basis, 30 minutes per day. The control group will have no device. After 4 weeks of FU, measurements will be repeated.
Read the detailed description
Drop out:
If subjects drop out, due to any kind of reason, a new participant will be included in order to obtain the predetermined number of participants. Data collected from the participant that dropped out will be deleted and not taken into account in the further analysis.
Analysis of the samples:
Sample size is based on data from (Dailey et al. 2013). Researchers found a significant difference in the reduction of movement-evoked pain (pain during the 6 minutes' walk test (6MWT)) ((4.0 ± 2.5) on a 0-10 VAS) when compared to no TENS (5.0 ± 2.6) (p<0.05) in patients with primary fibromyalgia.
In this study the response within each subject group was normally distributed. If the true difference in the experimental and control means is 1.0, effect size is calculated to be 0,2 (by means of G*Power version 3.1.9.3). 29 experimental subjects and 29 control subjects need to be included to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. To take into account a 15% loss of data sample size is inflated up to 33 per group (n/0.85). Sample size is augmented by 10% per potential confounding factor (i.e. age and sex). The total sample size to be recruited will be 70 subjects.
Statistical analysis:
The person to conduct the statistical analyses will be Lynn Leemans (Human Physiology and Anatomy (KIMA), Vrije Universiteit Brussel).
An intention-to-treat analysis will be performed so that the integrity of the randomization is ensured. Normality will be checked via the Shapiro-Wilk test.
To ensure good balance of participant characteristics in each group at baseline, stratification is used. Changes in differences between both treatment groups after the intervention period (at 4w) will be analyzed using repeated measures ANOVA for the following variables: sensitivity to movement-evoked pain, quality of life, pressure pain thresholds, temporal summation and conditioned pain modulation.
If the modulus of the partial correlation of potential confounding factors age and sex with the primary outcome values equals minimum 0.3, these covariates of prognostic values will be added as covariates in the ANOVA model.
As a secondary analysis, a linear regression analysis will be used with the following dependent factors: BMI, and as independent factors: sensitivity to movement-evoked pain, pressure pain thresholds, temporal summation, conditioned pain modulation, fear avoidance beliefs and quality of life.
Significance value for all tests will be set at p < 0.05. All analyses will be performed using SPSS 20 for Mac.
Quality control and quality assurance:
All electronic data will be stored on the shared drive of a university computer, which is encrypted; and on a password protected laptop belonging to the principal researcher (Lynn Leemans). Transfer of data will only be done if essential.
All anonymised data will be stored for up to four years to allow for access before publication, and may be required at a later date for further analysis and auditing. All personal data, including health questionnaires and signed consent forms, will be destroyed within 12 months of the study finishing.
Publication policy:
Both parties (VUB and Omron) acknowledge the importance of public disclosure of information collected of generated because of this clinical study. Omron retains the ability before publication to verify and ensure correct and accurate information is represented of the product and the brand used (product names, product types, brand name, product code) with no influence of the scientific results and conclusions of the integrity of the publication.
- Conditions
- Chronic Low Back Pain, Movement Evoked Pain
- Being tested
- HeatTens (HV-F311-E)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeatTens (HV-F311-E)Device
Patients need to apply the device during 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HeatTens | Experimental | After baseline measurements and during 4 weeks of follow up
Composition and dosing of the device:
HeatTens (HV-F311-E) 2 - 108 Hz (modulation), 100 microsec (pulse duration) for 30 minutes. Receives: Device: HeatTens (HV-F311-E) |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Evoked Pain
Pain that is experienced in response to a physical task. Participants will perform 5 physical tasks (= 1) grasping toes with fingertips in a sitting position; 2) forward bending from standing; 3) picking up paper from standing; 4) long-sitting from supine and 5) lifting a 5kg box from floor to table). Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)
Measured: Change from Baseline Movement Evoked Pain after treatment and at 4 weeks
Secondary outcomes (8)
5 minute walk test (5MWT)
Subjects need to walk as far as possible in 5 minutes
Measured: Change from Baseline 5MWT after treatment and at 4 weeks
Pressure Pain Threshold (PPT)
This measures deep tissue hyperalgesia, defined as the point at witch the pressure sensation turned into pain.
Measured: Change from Baseline Pressure Pain Threshold after treatment and at 4 weeks
Temporal summation (TS)
This is used to evaluate (endogenous) pain facilitation. Temporal summation is induced trough 10 pressure pulses with a hand held algemener (Somedic AB, Farsta, Sweden) at the Pressure Pain Threshold intensity. Patients will rate their pain level at the first, 5th and 10th pulse. Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)
Measured: Change from Baseline Tempral Summation after treatment and at 4 weeks
Conditioned pain modulation
This is used to evaluate the ability of the brain to moderate pain. In Conditioned pain modulation, a painful stimulus produces a decrease in pain outside the area of the applied stimulus. The mechanism behind it can be described as "pain inhibits pain". To induce pain and therefore trigger CPM response, participants put their hand in cold water for 2 minutes. Patients need to rate their level of pain (applied stimulus) on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)
Measured: Change from Baseline Conditioned pain modulation after treatment and at 4 weeks
Fear Avoidance Beliefs Questionnaire- work
Catastrophic thoughts and believes in chronic pain patients
Measured: Change from Baseline Fear Avoidance Beliefs Questionnaire after treatment and at 4 weeks
Quality of life (SF-36)
Quality of life, due to their low back pain, experienced by the patients will be evaluated
Measured: Change from Baseline Quality of Life after treatment and at 4 weeks
Central sensitization inventory
To report signs of central sensitization and its overlapping symptoms
Measured: Change from Baseline Central sensitization inventory after treatment and at 4 weeks
Body composition and Body Mass Index (BMI)
These two assessments are used to evaluate overweight and obesity in chronic low back patients. Body composition will be described in percentages of fat and muscle (%). Weight (in kilograms) and height (in meters) will be assessed as well and will be combined to report BMI in kg/m^2. The ViVa body composition monitor (OMRON) will be used for these measurements. Accepted classification for overweight and obesity by BMI: <18.5 = underweight; 18.5-24.5 = normal; 25.0-29.9 = overweight and >30.0= obesity.
Measured: Change from Baseline Body composition and BMI at 4 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start29 Aug 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Responsible party
- Principal investigator, Lynn Leemans, Vrije Universiteit Brussel
- Investigators
- David Beckwée, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643731
- Sponsor's protocol ID
- B.U.N. 143201836092
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leemans L, Elma O, Nijs J, Wideman TH, Siffain C, den Bandt H, Van Laere S, Beckwee D. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. 2021 Jan-Feb;25(1):86-96. doi: 10.1016/j.bjpt.2020.04.001. Epub 2020 May 12.
PubMed 32434666
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.
- ClinicalTrials.gov ID
- NCT03643731
- Acronym / sponsor ID
- B.U.N. 143201836092
- Conditions
- Chronic Low Back Pain, Movement Evoked Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 23 Aug 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.
A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Following baseline measurements, subjects will be randomly allocated to the experimental or the control group. The experimental group will be asked to use the device on a daily basis, 30 minutes per day. The control group will have no device. After 4 weeks of FU, measurements will be repeated.
Detailed description
Drop out:
If subjects drop out, due to any kind of reason, a new participant will be included in order to obtain the predetermined number of participants. Data collected from the participant that dropped out will be deleted and not taken into account in the further analysis.
Analysis of the samples:
Sample size is based on data from (Dailey et al. 2013). Researchers found a significant difference in the reduction of movement-evoked pain (pain during the 6 minutes' walk test (6MWT)) ((4.0 ± 2.5) on a 0-10 VAS) when compared to no TENS (5.0 ± 2.6) (p<0.05) in patients with primary fibromyalgia.
In this study the response within each subject group was normally distributed. If the true difference in the experimental and control means is 1.0, effect size is calculated to be 0,2 (by means of G*Power version 3.1.9.3). 29 experimental subjects and 29 control subjects need to be included to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. To take into account a 15% loss of data sample size is inflated up to 33 per group (n/0.85). Sample size is augmented by 10% per potential confounding factor (i.e. age and sex). The total sample size to be recruited will be 70 subjects.
Statistical analysis:
The person to conduct the statistical analyses will be Lynn Leemans (Human Physiology and Anatomy (KIMA), Vrije Universiteit Brussel).
An intention-to-treat analysis will be performed so that the integrity of the randomization is ensured. Normality will be checked via the Shapiro-Wilk test.
To ensure good balance of participant characteristics in each group at baseline, stratification is used. Changes in differences between both treatment groups after the intervention period (at 4w) will be analyzed using repeated measures ANOVA for the following variables: sensitivity to movement-evoked pain, quality of life, pressure pain thresholds, temporal summation and conditioned pain modulation.
If the modulus of the partial correlation of potential confounding factors age and sex with the primary outcome values equals minimum 0.3, these covariates of prognostic values will be added as covariates in the ANOVA model.
As a secondary analysis, a linear regression analysis will be used with the following dependent factors: BMI, and as independent factors: sensitivity to movement-evoked pain, pressure pain thresholds, temporal summation, conditioned pain modulation, fear avoidance beliefs and quality of life.
Significance value for all tests will be set at p < 0.05. All analyses will be performed using SPSS 20 for Mac.
Quality control and quality assurance:
All electronic data will be stored on the shared drive of a university computer, which is encrypted; and on a password protected laptop belonging to the principal researcher (Lynn Leemans). Transfer of data will only be done if essential.
All anonymised data will be stored for up to four years to allow for access before publication, and may be required at a later date for further analysis and auditing. All personal data, including health questionnaires and signed consent forms, will be destroyed within 12 months of the study finishing.
Publication policy:
Both parties (VUB and Omron) acknowledge the importance of public disclosure of information collected of generated because of this clinical study. Omron retains the ability before publication to verify and ensure correct and accurate information is represented of the product and the brand used (product names, product types, brand name, product code) with no influence of the scientific results and conclusions of the integrity of the publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeatTens | Experimental | Device: HeatTens (HV-F311-E)After baseline measurements and during 4 weeks of follow up Composition and dosing of the device: HeatTens (HV-F311-E) 2 - 108 Hz (modulation), 100 microsec (pulse duration) for 30 minutes. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).
Key exclusion criteria (4 listed)
- spinal surgery in the past 6 months
- severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),
- pregnant or given birth in the preceding year,
- having initiated a new LBP treatment in the 6 weeks prior to study participation
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 |
|---|---|---|
| HeatTens (HV-F311-E)Patients need to apply the device during 30 minutes. | Device | HeatTens |
Primary outcome
Movement Evoked Pain
Time frame: Change from Baseline Movement Evoked Pain after treatment and at 4 weeks
Pain that is experienced in response to a physical task. Participants will perform 5 physical tasks (= 1) grasping toes with fingertips in a sitting position; 2) forward bending from standing; 3) picking up paper from standing; 4) long-sitting from supine and 5) lifting a 5kg box from floor to table). Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)
8 secondary outcomes
5 minute walk test (5MWT)
Time frame: Change from Baseline 5MWT after treatment and at 4 weeks
Pressure Pain Threshold (PPT)
Time frame: Change from Baseline Pressure Pain Threshold after treatment and at 4 weeks
Temporal summation (TS)
Time frame: Change from Baseline Tempral Summation after treatment and at 4 weeks
Conditioned pain modulation
Time frame: Change from Baseline Conditioned pain modulation after treatment and at 4 weeks
Fear Avoidance Beliefs Questionnaire- work
Time frame: Change from Baseline Fear Avoidance Beliefs Questionnaire after treatment and at 4 weeks
Quality of life (SF-36)
Time frame: Change from Baseline Quality of Life after treatment and at 4 weeks
Central sensitization inventory
Time frame: Change from Baseline Central sensitization inventory after treatment and at 4 weeks
Body composition and Body Mass Index (BMI)
Time frame: Change from Baseline Body composition and BMI at 4 weeks follow up
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 6 Sep 2019.
- Derived from this study: PubMed 32434666Leemans L, Elma O, Nijs J, Wideman TH, Siffain C, den Bandt H, Van Laere S, Beckwee D. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. 2021 Jan-Feb;25(1):86-96. doi: 10.1016/j.bjpt.2020.04.001. Epub 2020 May 12.
- Individual participant dataSharing planned: Undecided
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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.
David Beckwée, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeatTens (HV-F311-E) in people with Chronic Low Back Pain and Movement Evoked Pain, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 1 inclusion and 4 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 6 Sep 2019. 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 Belgium. 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?
Movement Evoked Pain (time frame: Change from Baseline Movement Evoked Pain after treatment and at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643731, which also lists 1 linked publication.
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 6 Sep 2019.