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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HIT program
conventional rehabilitation program
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

Control group

Arm Description

Hit program for the rehabilitation of persons with nonspecific chronic low backpain

a conventional rehabilitation program for persons with nonspecific chronic low backpain

Outcomes

Primary Outcome Measures

Pain
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
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
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
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
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
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
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
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
Measured by Dual Energy X-ray absorptiometry (DEXA)
Body composition
Measured by Dual Energy X-ray absorptiometry (DEXA)
weight
Weight
BMI (Body Mass Index)
BMI (Body Mass Index)

Secondary Outcome Measures

physical activity
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
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
Short Form Health Survey (SF-36)
disability in participation and quality of life
Short Form Health Survey (SF-36)
Questionaire motivation and Therapy Adherence
Questionaire motivation and Therapy Adherence
questionaire

Full Information

First Posted
May 19, 2016
Last Updated
September 16, 2016
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02786316
Brief Title
High Intensity Training With Non-specific Chronic Low Back Pain
Acronym
LBP-HIT
Official Title
High Intensity Training in Patients With Non-Specific Chronic Low Back Pain: A Clinical Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Hit program for the rehabilitation of persons with nonspecific chronic low backpain
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
a conventional rehabilitation program for persons with nonspecific chronic low backpain
Intervention Type
Other
Intervention Name(s)
HIT program
Intervention Description
HIT program for the rehabilitation of persons with NSCLBP
Intervention Type
Other
Intervention Name(s)
conventional rehabilitation program
Intervention Description
a conventional rehabilitation program in persons with NSCLBP
Primary Outcome Measure Information:
Title
Pain
Description
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
Time Frame
day 1
Title
Pain
Description
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
Time Frame
week 6
Title
Kinesiophobia
Description
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.
Time Frame
day 1
Title
Kinesiophobia
Description
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.
Time Frame
week 6
Title
physical disability
Description
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
Time Frame
day 1
Title
physical disability
Description
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
Time Frame
week 6
Title
Endurance capacity
Description
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Time Frame
day 1
Title
Endurance capacity
Description
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Time Frame
week 6
Title
Body composition
Description
Measured by Dual Energy X-ray absorptiometry (DEXA)
Time Frame
day 1
Title
Body composition
Description
Measured by Dual Energy X-ray absorptiometry (DEXA)
Time Frame
week 6
Title
weight
Time Frame
day 1
Title
Weight
Time Frame
week 6
Title
BMI (Body Mass Index)
Time Frame
day 1
Title
BMI (Body Mass Index)
Time Frame
week 6
Secondary Outcome Measure Information:
Title
physical activity
Description
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.
Time Frame
day 1
Title
physical activity
Description
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.
Time Frame
week 6
Title
disability in participation and quality of life
Description
Short Form Health Survey (SF-36)
Time Frame
day 1
Title
disability in participation and quality of life
Description
Short Form Health Survey (SF-36)
Time Frame
week 6
Title
Questionaire motivation and Therapy Adherence
Time Frame
day 1
Title
Questionaire motivation and Therapy Adherence
Description
questionaire
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medically diagnosed with non-specific chronic low back pain4, over 18 years old, able to understand Dutch (spoken and written). Exclusion Criteria: invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed), radiculopathy (uni- or bilateral), 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, ongoing compensation claims and/or (work)disability > 6 months, rehabilitation/exercise therapy program for LBP in the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Verbrugghe, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Intensity Training With Non-specific Chronic Low Back Pain

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