Juvenile Osteochondrosis of SpineNCT03851367
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis
A study testing Sling suspension using red cord and Gym ball exercises in people with Juvenile Osteochondrosis of Spine, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls Read more about this study
- Who is it for?
- Ages 14 to 18 years, women only
- Conditions the study is for
- Juvenile Osteochondrosis of Spine
- What is being tested?
- Sling suspension using red cord and Gym ball exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female
Who cannot join
- any other medical diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Juvenile Osteochondrosis of Spine
- Being tested
- Sling suspension using red cord, Gym ball exercises
- Keywords
- back pain, suspension therapy, Gymball, standing posture, muscle endurance
- Medical subject headings
- Scheuermann Disease, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sling suspension using red cordProcedure or surgery
Also called SST
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.
Gym ball exercisesProcedure or surgery
Also called GBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Sling suspension therapy | Experimental | 3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each. Receives: Procedure: Sling suspension using red cord |
| Swiss ball therapy | Active comparator | 3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each. Receives: Procedure: Gym ball exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
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
Measured: baseline
Weight
Body weight was measured in kilograms with an accuracy of 100 g
Measured: baseline
Height
Body height was measured in meters with an accuracy of 5 mm
Measured: baseline
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.
Measured: baseline
Secondary outcomes (3)
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).
Measured: 3 weeks
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
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Osteochondrosis of SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, University of Brighton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851367
- Sponsor's protocol ID
- LithuanianSportsU
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is a plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis in Adolescent Girls
- ClinicalTrials.gov ID
- NCT03851367
- Acronym / sponsor ID
- LithuanianSportsU
- Conditions
- Juvenile Osteochondrosis of Spine
- Keywords
- back pain, suspension therapy, Gymball, standing posture, muscle endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, University of Brighton
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sling suspension therapy | Experimental | Procedure: Sling suspension using red cord3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each. |
| Swiss ball therapy | Active comparator | Procedure: Gym ball exercises3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female
Key exclusion criteria (1 listed)
- any other medical diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sling suspension using red cordAlso: SST3 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. | Procedure or surgery | Sling suspension therapy |
| Gym ball exercisesAlso: GBT3 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. | Procedure or surgery | Swiss ball therapy |
Primary outcome
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).
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
Weight
Time frame: baseline
Body weight was measured in kilograms with an accuracy of 100 g
Height
Time frame: baseline
Body height was measured in meters with an accuracy of 5 mm
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.
3 secondary outcomes
Change in Back pain
Time frame: 3 weeks
Change in Endurance of the trunk muscles
Time frame: 3 weeks
Improvement in Posture evaluation
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided. There is a plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling suspension using red cord and Gym ball exercises in people with Juvenile Osteochondrosis of Spine, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.