Clinical trial NCT03046472: Physical Therapy Treatment Once a Month Versus Once a Week for Posture Improvement in Children and Adolescents
Official title: Physical Therapy Treatment Once a Month Versus Physical Treatment Once a Week for Posture Improvement in Children and Adolescents Who Suffer From Posture Problem or Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Kyphosis, Thoracic Region
Keywords: thorax curve angle
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will consist of two groups: a Treatment group and a control group. Both groups will get personal meeting once a month and a program of exercising at home every day. Treatment group will have in addition group meeting once a week and control group not.
Primary purpose: TREATMENT

Brief summary: This study is design in a clinical setting for testing whether physical therapy treatment that includes postural awareness exercises for strength flexibility and endurance is improving low back pain and postural behavior. The study will consist of two groups, basic treatment that will get one on one treatment once a month for 3 months and the intervention group, will get an additional group therapy once a week.

Detailed description: Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from 32% to 66%. This prevalence gets higher with age and among 17 years old it's equal to prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to the next one, hence we should do preventative care at a young age, even before the first attack occur. Poor posture was found as one of the risk factors for Low Back Pain in children. Adolescence with neutral posture had less prevalence of Low Back Pain then those with poor posture. Prolong slouch sitting was associated with Low Back Pain. Prevention education programs, focusing on knowledge, did not show effective change in posture behavior. Hence, the researchers concluded that it's better if they focus on exercise.

Research Goal: comparison between physical therapy treatment for good posture once a week versus once a month, on postural behavior, thorax curve angle and Low Back Pain.

Research type: randomize, Interventional, blinded. Methods and Procedures Population: the study will include 50 children and adolescents age 10-18 years suffering from poor back posture, with or without Low Back Pain.

Procedure: The study will consist of two groups: both groups will get personal meeting once a month and a program of exercising at home every day. Treatment group will have in addition group meeting once a week and control group not. The intervention program will include physical awareness and practice for good posture, and exercises for flexibility, strength and muscle endurance.

Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural observation for measuring postural habits. Back pain and postural habits questionnaire for measuring LBP on VAS SCALE, postural knowledge and habits of participant, including demographic data. Parents' questionnaire for measuring parents' knowledge and ideas.

Research hypothesis: postural behavior, thorax curve angle and Low Back Pain will get better in both groups but more in the treatment group.

Eligibility criteria: Inclusion Criteria:

1. Children and Adolescent who referred by their pediatrician or orthopedic doctor to Physical Therapy treatment due to bad posture or Low Back Pain
2. At the Physical Therapy clinic was found that this is truly the condition of bad posture or low back pain with bad posture.
3. age 10-18 years
4. they signed on informed consent.

Exclusion Criteria:

1. Children and Adolescent who suffer from risk of structural deterioration as structural scoliosis(Cob angle above 20° and Risser sign equal or below 3) or structural Kyphosis (above 40° Risser sign equal or below 3 or Scheuermann Disease)
2. Any sever health condition neurologic internal or orthopedic like Cerebral Palsy, Juvenile rheumatoid arthritis or Malignancy.

Primary outcomes:
measure: Thoracic Kyphosis Angle
timeFrame: 2 time points. before starting intervention and after 3 months.
measure: Low Back Pain
timeFrame: 2 time points. before starting intervention and after 3 months.
measure: Back Postural Behavior
timeFrame: 2 time points. before starting intervention and after 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Modiin
country: Israel
facility: Phisical Therapy Clinic Maccabi Health Services
state: Jerusalem-Hashfela
Study officials:
affiliation: Deputy Medical Director-Maccabi Health Services-Jerusalem hashfela
name: Asaf Peretz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phisical Therapy Maccabi Health services-Modiin Clinic
name: Neta Vitman, PT BA
role: STUDY_DIRECTOR
References: