Trial document





This trial has been registered retrospectively.
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  DRKS00007652

Trial Description

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Title

Short-term effects of self-myofascial release compared to a conventional mobility exercise and no additional exercise on isometric strength in patients with chronic low-back pain

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This pilot study investigates whether certain types of physical exercise can increase short-term strength of the back muscles in persons with chronic low-back pain. Results of this study will contribute to improve back exercise programs and to get first insights for future studies on self-myofascial release. Participants will be randomized into one of three groups. All groups will do a 5-minute warm up on a bicycle ergometer. Then, two groups will receive additional exercises (self-myofascial release or conventional exercises), while the third group will not receive any additional exercises. Maximum isometric strength of back-extensors will be measured subsequently and used as the primary outcome.

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Brief Summary in Scientific Language

Randomized controlled monocentric trial with three study arms. The trial investigates immediate effects of myofascial self-release in comparison to conventional exercises or no exercises in maximum isometric strength of back-extensors. Maximum strength will be measured immediatly after exercises.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007652
  •   2015/01/27
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  •   yes
  •   Approved
  •   2014-109, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
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Interventions/Observational Groups

  •   5-minute warm up on a bycicle ergometer, then:
    1. Use of a blackroll ball on the plantar fascia of both feet, 30 seconds each side (“big foot” exercise)
    2. Use of a foam roll (“blackroll-orange STANDARD™”) on the dorsal fascia of both legs, 30 seconds each muscle group, thigh and lower leg. The foam roll is put under one thigh and the patient tries to roll down the whole thigh and the lower leg as far as possible. The patient supports his position using both hands.
    3. Self-myofascial manipulation of the thoracolumbar fascia with a foam roll (“blackroll-orange STANDARD™”). The patient sits on the foam roll and slides down the roll until the roll reaches the shoulders. During the exercise, the patient strains the abdominal muscles. Arms either are crossed before the chest or support the head. The exercise is exerted for 30 seconds, too.
    4. Patients will be instructed for a “fascial stretch”: a three-dimensional stretch of dorsal fasciae. The patient stands in front of chair, shoulder wide stance, hands on the seat going down into squat. The spine is stretched from buttock to top. In a next step the starting position is twisted to one side by moving the right side of the pelvis upwards and extending the right knee. Fingers and toes are extended, too, the patient looks at his right hand. The patient tries to stretch himself a little more until feeling a deep stretch on the right back side of the body. Repeat on the other side.
  •   5-minute warm up on a bycicle ergometer, then:
    Instructed and supervised classical exercise („cat & cow“) intended to stretch chest and back muscles, taking about 30 seconds:
    Starting position is on all-fours, wrists straight under the shoulders and knees under the hip. On exhalation the participant slowly arches his back, movement starting from the hips to the head. On inhalation the participant performs a reverse motion, again starting with moving the hip. Resulting in a concave position of the back.
  •   5-minute warm up on a bycicle ergometer.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Maximum exerted isometric strength of back-extensors in Newtonmeter, directly after the exercises. Measurement will be done using "Rumpf-Extension pro (TM)".

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/11/07
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• chronic low-back pain persisiting more than 6 months or recurring within the last 24 months for at least 3 times with a duration of 2 weeks or longer
AND deconditioned back muscles (Denner grade III and IV) or proceeding chronification (Gerbershagen/Schmitt grade 1 and 2) OR
• chronic-recurring low-back pain for more than 3 months with:
-disc prolapse or propulsion (without compression symptoms)
-degenerative diseases like: spondylosis; osteochondrosis, spondylolisthesis (Meyerding Grade 1 or 2)
-thoracolumbalscoliosis (Cobb angel up to 40 degree)
-osteopenia
-spinal canal stenosis (without acute symptoms)
-postnucleotomy syndrom (without compression symptoms)
-post-traumatic spine syndrom

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Exclusion Criteria

-disc prolapse with compression symptoms
-surgically treated disc prolapse within 3 months after procedure
-osteoporosis
-diabetes (insulin-dependent)
-coronary heart disease with activity restrictions
-cardiac insufficiency
-tumors
-mentall illness
-decompensated spondylolisthesis (Meyerding Grade 3 or 4)
-acute systemic inflammatory diseases
-thoracolumbalscoliosis (Cobb angel > 40 degree)
-fractures within the last 4 months
-abdominal or gyneacological surgery within the last 3 months
-umbilical or incisional hernia
-neurologic diseases with a progredient course
-serious vascular diseases (e.g. aneurysma, embolism, thrombosis, or arterial occlusive disease)
-serious cardiovascular disease (e.g. unstable coronary heart disease and cardiac insufficiency, and cardiomypathy)
-retinal detachment or glaucoma
-acute illness or illness that needs surgical treatment
-manifest osteporosis (with fractures)

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Addresses

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    • Martin-Luther-Univerisität Halle-Wittenberg
    • Mr.  Dr.  Steffen  Fleischer 
    • Magdeburger Str. 8
    • 06112  Halle/Saale
    • Germany
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    • Martin-Luther-Univerisität Halle-Wittenberg
    • Mr.  Dr.  Steffen  Fleischer 
    • Magdeburger Str. 8
    • 06112  Halle/Saale
    • Germany
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    • Martin-Luther-Univerisität Halle-Wittenberg
    • Mr.  Dr.  Steffen  Fleischer 
    • Magdeburger Str. 8
    • 06112  Halle/Saale
    • Germany
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Sources of Monetary or Material Support

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    • Martin-Luther-Univerisität Halle-Wittenberg
    • Mr.  Dr.  Steffen  Fleischer 
    • Magdeburger Str. 8
    • 06112  Halle/Saale
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/30
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Trial Publications, Results and other Documents

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