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Completed

NCT Number: NCT07109037

Clinical Study on the Improvement of Adult Idiopathic Scoliosis by Sling Exercise Therapy Training Combined With Conventional Exercise Therapy

This study aims to compare the effects of suspension exercise therapy combined with conventional exercise therapy and conventional exercise therapy alone on pain, Cobb angle, functional impairment, and quality of life in adult patients with idiopathic scoliosis.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Power-sling suspension device (SPS-F11, Nanjing Sbird Biotechnology Co., Ltd.)

Neijiang, Sichuan, 642450, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In the anteroposterior and lateral X-ray films of the spine in the standing position, the Cobb angle is ≥10° and <40°
  • The age ranges from 18 to 75 years old
  • No previous history of surgery
  • Not wearing a corrective brace

Exclusion criteria

  • Having mental illnesses
  • Having severe cognitive and communication disorders
  • Having severe cardiopulmonary dysfunction or cardiovascular diseases
  • Having adult degenerative and secondary scoliosis

Treatment and study plan

Conventional exercise therapy

Other

Conventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes .

Suspension training and conventional exercise therapy

Other

Suspension training alternates with conventional exercise therapy. It is conducted every other day, 45 minutes each time, 2-3 times a week for four consecutive weeks. Elastic ropes for suspension training are chosen based on patients' body mass: single - strand for those with body mass ≤ 30 kg and double - strand for those with body mass > 30 kg. Suspension slings are placed on the head, lower back, and pelvis, and non-elastic rope slings on the ankles. Lower the lifting bed so that the vertical distance from the ankles to the bed surface is about 25-30 cm.

Primary outcomes

  1. Cobb angle

    Time frame: The measurements and evaluations were conducted on the first day of treatment and after the completion of the 30 - day treatment respectively.

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

    The Oswestry Disability Index (ODI) scale consists of 10 dimensions, such as walking, sitting, standing, and self-care ability. Each dimension is scored on a scale from 0 to 5 points, yielding a maximum total score of 50 points and a Minimum total score of 0 points. A higher score on the ODI indicates a more severe degree of functional impairment. The results of the ODI can be classified into four grades: a score range of 0%-20% suggests mild impairment; 21%-40% indicates moderate impairment; 41%-60% represents severe impairment; and 61%-100% reflects extremely severe functional impairment.

  2. Pain score (Visual Analogue Scale, VAS)

    Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

    The Visual Analogue Scale(VAS) is a 0-10 scale, with 0 signifying no pain and 10 representing the most excruciating pain one can conceive. When administering the VAS, ensure that the graduated side of the scale is not visible to the patient. Then, ask the patient to mark the point on the ruler that reflects their current pain level. After that, the physician will assign a score according to the marked position. Based on the obtained score, pain can be classified as follows: a score of ≤3 indicates mild pain, 4-6 corresponds to moderate pain, and a score of ≥ 7 represents severe pain.

  3. Quality of life assessment (Scoliosis Research Society - 22 questionnaire, SRS - 22)

    Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

    The Scoliosis Research Society-22 (SRS-22) questionnaire was employed to assess the QOL of patients. It evaluates quality of life across five dimensions: functional activities, pain, self -image, psychological state, and treatment satisfaction. Each item is scored from 1 to 5, and the total score, with a maximum of 110 and minimum of 0 , reflects a better QOL as it increases.

Sponsors and collaborators

Lead sponsor

Southwest Medical University

Other

Registry information

Official study title

Therapeutic Efficacy of Combined Sling Exercise Therapy and Conventional Exercise Therapy in Adult Idiopathic Scoliosis:A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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