Clinical trial NCT02968043: Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Official title: Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis Idiopathic Adolescent
Keywords: physiotherapeutic scoliosis specific exercise
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital Chongming Branch
name: Shanghai First Rehabilitation Hospital
name: Shanghai Yangzhi Rehabilitation Hospital
name: Shanghai Yangpu Daqiao Community Health Service Center
First posted: 2016-11-18
Enrollment: 42
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.

Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.

Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.

Detailed description: Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients and has been widely used to reduce spinal deformity and halt curve progression. There are two kinds of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.

The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight, shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be evaluated and recorded. The following information will be obtained for all subjects, including demographic data (for example, age and sex), menarche status for the girls, and family history. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.

Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs under the guidance of an experienced physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will receive the treatment as allocated and will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.

Eligibility criteria: Inclusion Criteria:

* patients who are consistent with the diagnosis of adolescent idiopathic scoliosis suggested by Scoliosis Research Society
* the largest Cobb angle of less than 20 degrees on whole spine posterior-anterior X-ray radiographs in a standing position
* 10 to 16 years old
* skeletal immaturity with Risser sign of \<3

Exclusion Criteria:

* previous exercises or brace treatment history
* previous operation history of spine or lower extremities
* scoliosis caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases
* having contraindications to exercises

Primary outcomes:
measure: Change from Baseline Cobb's Angle at 6 months
timeFrame: up to 6 months
Secondary outcomes:
measure: Rotation Angle of Apical Vertebral
timeFrame: up to 6 months
measure: Change from Baseline Fall Index at 6 months
timeFrame: up to 6 months
measure: Change from Baseline Forced Vital Capacity at 6 months
timeFrame: up to 6 months
measure: Change from Baseline Forced Expiratory Volume in First Second at 6 months
timeFrame: up to 6 months
measure: Change from Baseline Nondominant Radius Speed of Sound at 6 months
timeFrame: up to 6 months
measure: Scores of Scoliosis Research Society-22 Questionnaire
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Chongming Branch
state: Shanghai
Study officials:
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Qing Du, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: