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Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis

Primary Purpose

Juvenile Osteochondrosis of Spine

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Sling suspension using red cord
Gym ball exercises
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Osteochondrosis of Spine focused on measuring back pain, suspension therapy, Gymball, standing posture, muscle endurance

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female

Exclusion Criteria:

  • any other medical diagnosis

Sites / Locations

  • Vilma Dudoniene

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sling suspension therapy

Swiss ball therapy

Arm Description

3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.

3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.

Outcomes

Primary Outcome Measures

Back pain
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).
Endurance of the trunk muscles
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
Weight
Body weight was measured in kilograms with an accuracy of 100 g
Height
Body height was measured in meters with an accuracy of 5 mm
Posture evaluation
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.

Secondary Outcome Measures

Change in Back pain
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).
Change in Endurance of the trunk muscles
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
Improvement in Posture evaluation
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.

Full Information

First Posted
February 20, 2019
Last Updated
February 22, 2019
Sponsor
Lithuanian Sports University
Collaborators
Lithuanian University of Health Sciences, University of Brighton
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1. Study Identification

Unique Protocol Identification Number
NCT03851367
Brief Title
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis
Official Title
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis in Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University
Collaborators
Lithuanian University of Health Sciences, University of Brighton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Osteochondrosis of Spine
Keywords
back pain, suspension therapy, Gymball, standing posture, muscle endurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects were recruited from an inpatient rehabilitation department, specializing in the treatment of children and adolescents with degenerative disorders. The research population consisted of 40 adolescents-girls, who were diagnosed with juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42.0). All subjects were randomly divided into two groups: Sling Suspension Therapy, and Gymball therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sling suspension therapy
Arm Type
Experimental
Arm Description
3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.
Arm Title
Swiss ball therapy
Arm Type
Active Comparator
Arm Description
3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.
Intervention Type
Procedure
Intervention Name(s)
Sling suspension using red cord
Other Intervention Name(s)
SST
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gym ball exercises
Other Intervention Name(s)
GBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Back pain
Description
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).
Time Frame
baseline
Title
Endurance of the trunk muscles
Description
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
Time Frame
baseline
Title
Weight
Description
Body weight was measured in kilograms with an accuracy of 100 g
Time Frame
baseline
Title
Height
Description
Body height was measured in meters with an accuracy of 5 mm
Time Frame
baseline
Title
Posture evaluation
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Change in Back pain
Description
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).
Time Frame
3 weeks
Title
Change in Endurance of the trunk muscles
Description
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
Time Frame
3 weeks
Title
Improvement in Posture evaluation
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only adolescents girls
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female Exclusion Criteria: any other medical diagnosis
Facility Information:
Facility Name
Vilma Dudoniene
City
Kaunas
ZIP/Postal Code
44221
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is a plan to share IPD with other researchers

Learn more about this trial

Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis

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