Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.
Condition: Chronic Low Back Pain; Movement Evoked Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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. 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.
    

Intervention name(s): HeatTens (HV-F311-E)
Intervention type(s): Device
Intervention description(s): Patients need to apply the device during 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment