Long-term Effectiveness of Integrative Scoliosis-specific Rehabilitation in High-risk Adolescent Idiopathic Scoliosis

NCT06672029 | Completed DMC

• 1 other identifier: 20241003R
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. The management and treatment of AIS includes observation, physiotherapy (or therapeutic exercise), brace application, and surgery. Evidence of the conservative management of AIS has been stronger in recent years. However, the best combination therapy has not been well established. Moreover, the investigator has demonstrated an innovation of pattern-specific manual therapy to treat AIS. Different from previous conservative treatment, the investigators applied specific treatment for different patterns of AIS according to the Lehnert-Schroth (LS) scoliosis classification. Therefore, the investigators aim to determinate the long-term effects of the integrative scoliosis-specific rehabilitation program combining pattern-specific manual therapy, Schroth Best Practice (SBP) exercise, and Gensingen brace application in treating AIS patients.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

adolescent idiopathic scoliosis; manual therapy; Schroth Best Practice; Gensingen brace; scoliosis-specific rehabilitation program

Outcome Measures

Primary Outcomes (2)

• Angle of trunk rotation (ATR)

  The ATR was measured with a Scoliometer™ in a forward bending posture. It is defined as the angle between the horizontal plane and the plane across the posterior aspect of the back, and the minimal clinically important difference (MCID) is 5 degrees.

  measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course

• Cobb angle

  The Cobb angles of major curves were measured via standing posteroanterior radiograph. Based on the consensus of SOSORT and SRS non-operative management committee, radiographic definitions of improvement is 6 degrees or more.

  measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course

Secondary Outcomes (1)

• lateral deviation

  measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course

Study Arms (1)

Patients with adolescent idiopathic scoliosis

EXPERIMENTAL

All patients receive a combination of therapy including the three listed below: * The pattern-specific manual therapy * The Schroth Best Practice exercises * The Gensingen brace application

Other: combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application

Interventions

combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application OTHER

* The pattern-specific manual therapy: It was developed by our author. This therapy was done immediately before each SBP (Schroth Best Practice) exercise session, targeting both the spine and extra-spinal regions. * The Schroth Best Practice exercises: It contains following 6 components: The physio-logic® program for sagittal profile correction, education on activities of daily living (ADLs), the "3D made easy" program, the new "Power Schroth" program, the rehabilitation of walk, and neuromobilization. * The Gensingen brace application: it was made according to the patients' Lehnert Schroth Classifications. the investigators recommended the patients to wear the brace for 21-23 hours per day during the first year. As the bone maturation reached Risser 4 to 4.5, the daily brace wearing time was gradually reduced.

Patients with adolescent idiopathic scoliosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) fulfill a diagnosis of AIS;
• \) age between 10 and 18 years old;
• \) Cobb angle ≧ 20˚;
• \) incidence of progression over 60% according to Lonstein et al. ;
• \) never underwent treatment that might affect scoliosis;
• \) complete follow-ups of at least 12 months after the end of treatment.

You may not qualify if:

• \) A diagnosis of non-idiopathic scoliosis (e.g. secondary or functional scoliosis);
• \) any psychological problems;
• \) pregnancy;
• \) any severe rheumatic or chronic neuromuscular diseases (e.g. rheumatoid arthritis, ankylosing spondylitis);
• \) any severe orthopedic problems (e.g. bone tumor, fracture);
• \) refusal of the suggested treatment;
• \) any previous or ongoing treatment of scoliosis;
• \) any contraindications to brace, exercise, or manipulative treatment.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Study Officials

• Lin-Fen Hsieh, M.D.

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: retrospective study

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 4, 2024
• Study Start: January 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: August 14, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

TW (1)