Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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German Clinical Trials Register |
Last refreshed on:
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8 April 2024 |
Main ID: |
DRKS00007652 |
Date of registration:
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27/01/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
Date of first enrolment:
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07/11/2014 |
Target sample size:
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60 |
Recruitment status: |
Complete |
URL:
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http://drks.de/search/en/trial/DRKS00007652 |
Study type:
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interventional |
Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Steffen
Fleischer |
Address:
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Magdeburger Str. 8
06112
Halle/Saale
Germany |
Telephone:
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0345 5574133 |
Email:
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steffen.fleischer@medizin.uni-halle.de |
Affiliation:
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Martin-Luther-Univerisität Halle-Wittenberg |
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Name:
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Steffen
Fleischer |
Address:
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Magdeburger Str. 8
06112
Halle/Saale
Germany |
Telephone:
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0345 5574133 |
Email:
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steffen.fleischer@medizin.uni-halle.de |
Affiliation:
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Martin-Luther-Univerisität Halle-Wittenberg |
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Key inclusion & exclusion criteria
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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
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)
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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M54
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Dorsalgia
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Intervention(s)
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Group 1: 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.
Group 2: 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
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Primary Outcome(s)
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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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Source(s) of Monetary Support
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Martin-Luther-Univerisität Halle-Wittenberg
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Ethics review
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Status: Approved
Approval date: 05/11/2014
Contact:
ethik-kommission@medizin.uni-halle.de
Ethik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
+49-345-5574476
ethik-kommission@medizin.uni-halle.de
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