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

• ClinicalTrials.gov Identifier: NCT03851367
• Recruitment Status: Completed
• First Posted: February 22, 2019
• Last Update Posted: February 26, 2019
• Sponsor: Lithuanian Sports University
• Collaborators: Lithuanian University of Health Sciences; University of Brighton
• Information provided by (Responsible Party): Lithuanian Sports University

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

Condition or disease	Intervention/treatment	Phase
Juvenile Osteochondrosis of Spine	Procedure: Sling suspension using red cord; Procedure: Gym ball exercises	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis in Adolescent Girls
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: September 30, 2018
• Actual Study Completion Date: December 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sling suspension therapy; 3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.	Procedure: Sling suspension using red cord; 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 Name: SST
Active Comparator: Swiss ball therapy; 3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.	Procedure: Gym ball exercises; 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 Name: GBT

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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
3. Weight [ Time Frame: baseline ]
   Body weight was measured in kilograms with an accuracy of 100 g
4. Height [ Time Frame: baseline ]
   Body height was measured in meters with an accuracy of 5 mm
5. 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.

Secondary Outcome Measures :

1. 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).
2. 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. 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: only adolescents girls
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• any other medical diagnosis

Contacts and Locations

Locations

Lithuania

Vilma Dudoniene

Kaunas, Lithuania, 44221

Sponsors and Collaborators

Lithuanian Sports University

Lithuanian University of Health Sciences

University of Brighton

More Information

• Responsible Party: Lithuanian Sports University
• ClinicalTrials.gov Identifier: NCT03851367
• Other Study ID Numbers: LithuanianSportsU
• First Posted: February 22, 2019
• Last Update Posted: February 26, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lithuanian Sports University:

back pain; suspension therapy; Gymball; standing posture; muscle endurance

Additional relevant MeSH terms:

Osteochondrosis; Spinal Osteochondrosis; Scheuermann Disease; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Kyphosis; Spinal Curvatures