- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851367
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis
February 22, 2019 updated by: Lithuanian Sports University
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis in Adolescent Girls
This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One of the main tasks in the treatment of osteochondrosis related back pain is training trunk stabilizing muscles.
This might be achieved by using a sling suspension exercise systems.
Redcord is a trademark for Sling Exercise Therapy.
Suspension exercise training has been shown to improves functional movement patterns more effectively than traditional exercise by creating a challenging and pain free environment for movement re-training.
Another commonly used option in the treatment of juvenile osteochondrosis is Gymball, also known as Swissball core training programmes that are popular trends in physiotherapy and strength and conditioning programs.
Benefits of Gymball core training exercises that facilitate spinal stability and balance have often been emphasized by researchers in development of strength and endurance, flexibility, and neuromuscular control as a cost effective and enjoyable way to treat and prevent back pain.
Both exercises modes are used in treatment of back pain and muscle training in young people with juvenile osteochondrosis, what is why this study aims to compare Sling Suspension therapy with Gymball exercise in this population.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaunas, Lithuania, 44221
- Vilma Dudoniene
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female
Exclusion Criteria:
- any other medical diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sling suspension therapy
3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.
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3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week.
Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.
Other Names:
|
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Active Comparator: Swiss ball therapy
3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.
|
3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week.
Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: baseline
|
Body height was measured in meters with an accuracy of 5 mm
|
baseline
|
|
Back pain
Time Frame: baseline
|
was evaluated using the Visual Analogue Pain Scale (VAS).
Participants were asked to report "current" pain intensity.
A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
|
baseline
|
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Endurance of the trunk muscles
Time Frame: baseline
|
was tested according those suggested by S. McGill (2007) and endurance duration was recorder in seconds.
The back extensors ; The trunk flexors ; The lateral musculature
|
baseline
|
|
Weight
Time Frame: baseline
|
Body weight was measured in kilograms with an accuracy of 100 g
|
baseline
|
|
Posture evaluation
Time Frame: baseline
|
Standing posture was evaluated by a commonly used clinical assessment technique - visual assessment.
In an attempt to minimize data collection error, one experienced examiner evaluated all the study participants' posture.
The examiner was blind to the scope of the study and to the group that the subjects belonged to.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Back pain
Time Frame: 3 weeks
|
was evaluated using the Visual Analogue Pain Scale (VAS).
Participants were asked to report "current" pain intensity.
A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
|
3 weeks
|
|
Change in Endurance of the trunk muscles
Time Frame: 3 weeks
|
was tested according those suggested by S. McGill (2007) and endurance duration was recorder in seconds.
The back extensors ; The trunk flexors ; The lateral musculature
|
3 weeks
|
|
Improvement in Posture evaluation
Time Frame: 3 weeks
|
Standing posture was evaluated by a commonly used clinical assessment technique - visual assessment.
In an attempt to minimize data collection error, one experienced examiner evaluated all the study participants' posture.
The examiner was blind to the scope of the study and to the group that the subjects belonged to.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (Actual)
February 22, 2019
Study Record Updates
Last Update Posted (Actual)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 22, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuanianSportsU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
There is a plan to share IPD with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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