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Integral Versus Local Movement Therapy Approach in Patients With Idiopathic Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03623802
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Nejc Sarabon, University of Primorska

Brief Summary:

Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials to date included mostly trunk strengthening exercises (e.g. bird dog, plank) and there is no evidence about supervised, individually graded integral movement therapy program for patients with chronic low back pain (CLBP).

The research design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy. Participants in each group will receive 20 supervised sessions in a 10 week period, two times per week, with approximately 1 hour per session. Outcome assessments will occur at baseline and immediately post-intervention, follow up will take place at 6 months and 12 months after finishing the intervention. Pre specified analyses will evaluate the main effects of the treatment.

This trial will use a novel, previously unexplored integral approach to CLBP through exercises. In contrast to commonly used exercise programs, the integral program does not include specific local strength exercises for hip and trunk flexors and extensors. However, learning dynamic trunk muscle control in various body positions with added limb movements could be beneficial because of the parallels to everyday work. The study will contribute to clinical practice by providing evidence to guide professionals when deciding for the proper and efficient treatment of patients with CLBP.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Local Movement Therapy Other: Integral Movement Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integral Movement Therapy Versus Local Movement Therapy Approach in Patients With Idiopathic Chronic Low Back Pain: a Randomized Controlled Trail.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Local Movement Therapy
Group receiving treatment in form of Local Movement Therapy Program.
Other: Local Movement Therapy
Loads and intensity of exercises will be increased according to participants' abilities. Modifications of exercises are made through different body positions or increasing the load. When a participant will be able to perform a certain number of repetitions and sets of a required exercise, without any compensatory movements, he/she can proceed to the next level of exercise. Breaks between exercises and sets are the same as in the integral movement therapy protocol. Protocol consists of four basic exercises, which are progressed through sessions: (I) Abdomen curl. (II) Trunk extension on roman chair. (III) Hip bridge. (IV) Side plank.

Experimental: Integral Movement Therapy
Group receiving treatment in form of Integral Movement Therapy Program.
Other: Integral Movement Therapy
Protocol consists of four basic exercises, which are progressed through sessions: (I) Proprioception - sitting on an unstable surface - Swiss ball, with additional tasks with legs and arms. (II) Strength - pushing task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (III) Strength - pulling task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (IV) Lifting and carrying the loads: a) Stoop lifting. b) Squat lifting. c) Half kneeling lifting.




Primary Outcome Measures :
  1. CHANGE IN INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (IPAQ) SCORE [ Time Frame: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up. ]
    The International Physical Activity Questionnaire (IPAQ) is developed to measure health-related physical activity (PA) in populations.

  2. Change in Oswestry Low Back Disability Questionnaire (ODI) Score [ Time Frame: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up. ]
    Oswestry Low Back Disability Questionnaire is used to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.

  3. Change inn Numeric Rating Scale for Pain (NRS) Score [ Time Frame: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up. ]
    The NRS for pain is a unidimensional measure of pain intensity in adults.


Secondary Outcome Measures :
  1. Change in Timed-up-and-go test (TUG) score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    TUG test measures physical function and correlates with fall risk.

  2. Change in Sit-to-stand test score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    Sit-to-stand test is used to measure of lower limb strength and related function.

  3. Change in Chair sit-and-reach test score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    The Chair Sit and Reach test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness. It is a variation of the traditional sit and reach flexibility test.

  4. Change in 6 minute walk test score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  5. Change in Spine flexibility. [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    We will use the Schober's test, which is a physical examination used in physical medicine. to measure the ability of a patient to flex the lower back.

  6. Change in Spinal extensor endurance [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    The Biering-Sorensen test is used for evaluating the isometric endurance of the hip and back extensor muscles. Participant being tested gets on the therapeutic table in a horizontal prone position with their arms crossed over the chest, chin tucked, and the upper edge of the iliac crest on the pad. Once they are in this full position, the timer is started.

  7. Change in Sharpened Romberg test score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    Sharpened Modified Romberg Test is used to assess postural stability. Participants stand in heel to toe position, with their arms folded across chest and eyes closed. The duration that they are able to maintain their balance is recorded. The test ceases at 30 sec or loss of balance (excessive sway, loss of balance, stepping during test, opening eyes).

  8. Change in Trunk Muscle Strength [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    Trunk Strength will be assessed by measuring maximal force that trunk muscles are able to exert in isometric conditions, on a custom-made dynamometer. Trunk extensors, flexors and lateroflexors will be tested.

  9. Change in trunk reposition error test score [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    In this test, participants are instructed to assume the position they are previously lead to. The difference between the position is described as the reposition error.

  10. Change in maximal pelvic inclination [ Time Frame: 1 week before the first therapy and after 11 weeks of therapy. ]
    Maximal pelvic inclination at full trunk flexion is an additional measure of lumbo-pelvic mobility.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic idiopathic low back pain which persists at least 12 weeks or two acute low back pain episodes in the last 12 months.
  • Patients aged between 30 and 60 years.
  • Capable of at least low physical activity to be able to complete movement therapy program.

Exclusion Criteria:

  • Severe spinal stenosis, spondylolisthesis, fibromyalgia.
  • Lumbar spine surgery.
  • Vascular disease.
  • Neurological deficits because of nerve root or spinal cord compression.
  • Ongoing treatment for low back pain.
  • Pregnancy.
  • Comorbid health conditions that could prevent active participation in exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623802


Contacts
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Contact: Nejc Šarabon, PhD +386 40 429 505 ext +386 nejc.sarabon@fvz.upr.si
Contact: Suzana Pustivšek, PhD suza.pustivsek@gmail.com

Locations
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Slovenia
Health Center Kranj Recruiting
Kranj, Slovenia, 4000
Contact: Suzana Pustivšek, PhD       suza.pustivsek@gmail.com   
Sponsors and Collaborators
University of Primorska
Investigators
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Principal Investigator: Nejc Šarabon, PhD Faculty of Health Sciences, University of Primorska, Slovenia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nejc Sarabon, Assoc. Prof. Dr. Sc., University of Primorska
ClinicalTrials.gov Identifier: NCT03623802     History of Changes
Other Study ID Numbers: LBPStudy-0120-93/2018/6
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nejc Sarabon, University of Primorska:
Chronic low back pain
Movement therapy
Supervised training

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms