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

• ClinicalTrials.gov Identifier: NCT02786316
• Recruitment Status: Completed
• First Posted: June 1, 2016
• Last Update Posted: September 19, 2016
• Sponsor: Hasselt University
• Collaborator: Jessa Hospital
• Information provided by (Responsible Party): Annick Timmermans, Hasselt University

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: HIT program; Other: conventional rehabilitation program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Intensity Training in Patients With Non-Specific Chronic Low Back Pain: A Clinical Pilot Trial
• Study Start Date: January 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: intervention group; Hit program for the rehabilitation of persons with nonspecific chronic low backpain	Other: HIT program; HIT program for the rehabilitation of persons with NSCLBP
Active Comparator: Control group; a conventional rehabilitation program for persons with nonspecific chronic low backpain	Other: conventional rehabilitation program; a conventional rehabilitation program in persons with NSCLBP

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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.
4. 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.
5. 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
6. 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
7. 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).
8. 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).
9. Body composition [ Time Frame: day 1 ]
   Measured by Dual Energy X-ray absorptiometry (DEXA)
10. Body composition [ Time Frame: week 6 ]
    Measured by Dual Energy X-ray absorptiometry (DEXA)
11. weight [ Time Frame: day 1 ]
12. Weight [ Time Frame: week 6 ]
13. BMI (Body Mass Index) [ Time Frame: day 1 ]
14. BMI (Body Mass Index) [ Time Frame: week 6 ]

Secondary Outcome Measures :

1. 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.
2. 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.
3. disability in participation and quality of life [ Time Frame: day 1 ]
   Short Form Health Survey (SF-36)
4. disability in participation and quality of life [ Time Frame: week 6 ]
   Short Form Health Survey (SF-36)
5. Questionaire motivation and Therapy Adherence [ Time Frame: day 1 ]
6. Questionaire motivation and Therapy Adherence [ Time Frame: week 6 ]
   questionaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Belgium

Jessa Ziekenhuis

Hasselt, Belgium, 3500

Sponsors and Collaborators

Hasselt University

Jessa Hospital

Investigators

• Study Chair: Jonas Verbrugghe, prof. dr.; Hasselt University

More Information

• Responsible Party: Annick Timmermans, prof. dr., Hasselt University
• ClinicalTrials.gov Identifier: NCT02786316
• Other Study ID Numbers: LBP-HIT-001
• First Posted: June 1, 2016
• Last Update Posted: September 19, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations