Clinical trial NCT04539522: Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
Official title: A Prospective Clinical Study on the Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Scoliosis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 172
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may progress sharply during growth. It is recommended that the physiotherapeutic scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to prevent/limit progression of the deformity. Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS.

Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be divided into two groups(experimental group or control group) according to their wishes. Subjects in experimental group will perform three-dimensionally corrective exercise for scoliosis (moderate patients combined with a brace) and those in the control group will receive conventional exercise therapy (moderate patients combined with a brace).

Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.

Detailed description: Idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may progress sharply during growth. According to the severity of the curve, the major treatment approaches for patient with AIS include exercises, bracing and surgery, to correct, prevent or stop the progression of the deformity.In North America, Scoliosis Research Society (SRS) has been published the standard of care for AIS: patients with curves between 10 and 25° should be observation who are still growing. While in the Europe, the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) has recommended that the physiotherapeutic scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to prevent/limit progression of the deformity. Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS.

The present study is a single-center prospective non-randomised controlled trial conducted at the department of rehabilitation medicine, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine. The demographic data (height, weight), menarche status for the girls, family history, will be recorded by the physician.

Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be assigned by a 1:1 allocation ratio either to the experimental group, in which they will perform three-dimensionally integrated exercise for scoliosis, or the control group, in which they will receive the standard of care with observation according to the Scoliosis Research Society criteria. Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.

Eligibility criteria: Inclusion Criteria(meet all the following conditions):

1. Age between 8-16;
2. Definitely diagnosed as IS;
3. Patients with Cobb angle greater than or equal to 10° and less than 45°.

Exclusion Criteria(at least meet one of the following conditions):

1. Scoliosis caused by congenital, postural, neuromuscular or other diseases (such as neurofibromatosis, Marfan syndrome, bone dysplasia, metabolic or endocrine diseases, etc.);
2. Patients suffering from mental illness or rheumatic disease;
3. Patients with insufficient understanding ability to understand and complete the treatment plan;
4. Patients with exercise contraindications who cannot tolerate exercise therapy;
5. Patients with poor treatment compliance or refusal to treat;
6. Patients with a history of rehabilitation or surgery before the first visit;
7. Patients with apical vertebrae at T7 and above, or patients with mature bones.

Primary outcomes:
measure: Change of Cobb angle
timeFrame: up to 12 months
Secondary outcomes:
measure: Angle of trunk rotation
timeFrame: up to 12 months
measure: Sagittal index
timeFrame: up to 12 months
measure: Forced vital capacity
timeFrame: up to 12 months
measure: Forced expiratory volume in first second
timeFrame: up to 12 months
measure: Peak oxygen uptake
timeFrame: up to 12 months
measure: Scoliosis Research Society-22 (SRS-22) questionnaire score
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine
name: Qing Du, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou X, Li X, Wu Q, Liang J, Guo H, Jin M, Zhu X, Du Q. Three-dimensional corrective exercise therapy for idiopathic scoliosis: study protocol for a prospective non-randomized trial. BMC Musculoskelet Disord. 2022 Feb 5;23(1):118. doi: 10.1186/s12891-022-05057-7.