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High Intensity Training With Non-specific Chronic Low Back Pain (LBP-HIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786316
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Annick Timmermans, Hasselt University

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date September 19, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Pain [ Time Frame: day 1 ]
    Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
  • Pain [ Time Frame: week 6 ]
    Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
  • Kinesiophobia [ Time Frame: day 1 ]
    Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
  • Kinesiophobia [ Time Frame: week 6 ]
    Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
  • physical disability [ Time Frame: day 1 ]
    Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
  • physical disability [ Time Frame: week 6 ]
    Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
  • Endurance capacity [ Time Frame: day 1 ]
    Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
  • Endurance capacity [ Time Frame: week 6 ]
    Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
  • Body composition [ Time Frame: day 1 ]
    Measured by Dual Energy X-ray absorptiometry (DEXA)
  • Body composition [ Time Frame: week 6 ]
    Measured by Dual Energy X-ray absorptiometry (DEXA)
  • weight [ Time Frame: day 1 ]
  • Weight [ Time Frame: week 6 ]
  • BMI (Body Mass Index) [ Time Frame: day 1 ]
  • BMI (Body Mass Index) [ Time Frame: week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • physical activity [ Time Frame: day 1 ]
    Actigraph GT3X activity monitors Activity of the daily routine will be evaluated by means of wearing an accelerometer throughout 3 consecutive days. A schedule will be inventoried by the participant.
  • physical activity [ Time Frame: week 6 ]
    Actigraph GT3X activity monitors Activity of the daily routine will be evaluated by means of wearing an accelerometer throughout 3 consecutive days. A schedule will be inventoried by the participant.
  • disability in participation and quality of life [ Time Frame: day 1 ]
    Short Form Health Survey (SF-36)
  • disability in participation and quality of life [ Time Frame: week 6 ]
    Short Form Health Survey (SF-36)
  • Questionaire motivation and Therapy Adherence [ Time Frame: day 1 ]
  • Questionaire motivation and Therapy Adherence [ Time Frame: week 6 ]
    questionaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Training With Non-specific Chronic Low Back Pain
Official Title  ICMJE High Intensity Training in Patients With Non-Specific Chronic Low Back Pain: A Clinical Pilot Trial
Brief Summary

Low back pain is a common disorder, occurring worldwide in both males and females in all age groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).

Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.

Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy program was developed consisting of high intensity interval cardio and high load whole body strength training.

The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on disease related outcomes and physical fitness compared to a conventional rehabilitation program in persons with NSCLBP.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Other: HIT program
    HIT program for the rehabilitation of persons with NSCLBP
  • Other: conventional rehabilitation program
    a conventional rehabilitation program in persons with NSCLBP
Study Arms  ICMJE
  • Experimental: intervention group
    Hit program for the rehabilitation of persons with nonspecific chronic low backpain
    Intervention: Other: HIT program
  • Active Comparator: Control group
    a conventional rehabilitation program for persons with nonspecific chronic low backpain
    Intervention: Other: conventional rehabilitation program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. medically diagnosed with non-specific chronic low back pain4,
  2. over 18 years old,
  3. able to understand Dutch (spoken and written).

Exclusion Criteria:

  1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
  2. radiculopathy (uni- or bilateral),
  3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
  4. ongoing compensation claims and/or (work)disability > 6 months,
  5. rehabilitation/exercise therapy program for LBP in the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786316
Other Study ID Numbers  ICMJE LBP-HIT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Annick Timmermans, Hasselt University
Study Sponsor  ICMJE Hasselt University
Collaborators  ICMJE Jessa Hospital
Investigators  ICMJE
Study Chair: Jonas Verbrugghe, prof. dr. Hasselt University
PRS Account Hasselt University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP