Physical Therapy Treatment Once a Month Versus Once a Week for Posture Improvement in Children and Adolescents

Postural Kyphosis, Thoracic Region Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046472
• Other study ID #: Assuta-0133-16-ASMC-AP-CTIL
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2017
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kyphosis
• Postural Kyphosis, Thoracic Region

Intervention

Other:
• Physical Therapy treatment for Postural Behavior
Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance. All participants will get 10-15 minutes of exercise for performing every day.

Locations

Country	Name	City	State
Israel	Phisical Therapy Clinic Maccabi Health Services	Modiin	Jerusalem-Hashfela

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoracic Kyphosis Angle	Normal thoracic kyphosis angle ranges between 25°-40°. Measuring by Digital Inclinometer by placing it on the spinous process of T1 and T12 and the outcome off subtraction the two numbers is our out come.; The participant is to stand how ever he think is the best posture.	2 time points. before starting intervention and after 3 months.
Primary	Low Back Pain	VAS Scale 0-10 0 no pain 1-2 very mild pain 2-3 mild pain 4-6 moderate pain 7-8 high pain 9-10 very high pain	2 time points. before starting intervention and after 3 months.
Primary	Back Postural Behavior	the investigator observes the participant in 8 different positions: sitting in the waiting room, walking to the treatment room, sitting in front of the therapist, placing a mattress on the floor, exercising in six position, exercising in sitting position, exercising in standing position, and changing between positions. Each position get a subscore as 0-bad posture 1-fair 2-good. Overall postural behavior: was comprised of all 8 observations including: grades 0 to 16. An higher score is a better behavior.; spontaneous behavior was comprised of 4 sob score that ha a spontaneous characteristics: sitting waiting for treatment, walking into the room, sitting during treatment and transition between exercises. summation of these 4 would range 0-8 . an Higher score is a better behavior.	2 time points. before starting intervention and after 3 months.