NCT06563141

Brief Summary

This study aims to compare the effectiveness of mechanical traction and 3D apical vertebral mobilization and active exercises on Cobb's angle, spinal ROM, and function in patients with C-shaped scoliosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 17, 2024

Last Update Submit

August 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of degree of spinal curvature

    it will be assessed using the scoliometer which is typically consists of a level or inclinometer attached to a base. The scoliometer is placed along the spine, and the angle of deviation from the vertical is measured to assess the severity of the curvature

    at baseline and after 3 months

Secondary Outcomes (9)

  • assessment of the change of the weight, height and body mass index

    at baseline and after 3 months

  • assessment of the change of the trunk flexion and extension ROM

    at baseline and after 3 months

  • assessment of the change of the trunk lateral flexion ROM

    at baseline and after 3 months

  • assessment of the change of the trunk rotation ROM

    at baseline and after 3 months

  • assessment of the change of the cervical flexion and extension ROM

    at baseline and after 3 months

  • +4 more secondary outcomes

Study Arms (2)

traction with mobilization

EXPERIMENTAL

it consists of 35 patients and patients will receive traction with mobilization 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures

Other: traction and mobilization

active exercise therapy)

ACTIVE COMPARATOR

it consists of 35 patients and patients will active exercises 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures

Other: active exercise therapy

Interventions

The patient undergoes a 15-minute infrared therapy session, followed by flexibility and stretching exercises targeting the trunk and four extremities muscles. Land manipulation techniques are used for cervical, dorsal, and lumbar spine to assess and treat spinal dysfunctions. Deep breathing exercises with rib mobilization are also performed to promote respiratory function and thoracic flexibility. The session aims to improve overall health.

traction with mobilization

Patients with adolescent idiopathic scoliosis will receive exercise programs from seven major schools under SOSORT, focusing on realigning the spine, rib cage, shoulders, and pelvis to normal anatomical postures.

active exercise therapy)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult individuals aged 18 to 30 years (after complete ossification and before the start of the ageing process and joint changes) as mentioned in studies.
  • Thoracolumbar scoliosis with Cobb angle between 10 to 30 degrees because a curve below 10 degrees has no effect and above 30 is indicated for surgery.

You may not qualify if:

  • History of orthopaedic surgeries.
  • History of road traffic accidents (RTA).
  • Myopathy.
  • True leg length discrepancy.
  • Neuropathy.
  • Mental disorders.
  • Bone tumor.
  • Heart disease or circulatory problems.
  • Early osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

May University in Cairo (MUC)

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Traction

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Central Study Contacts

khalid safwat elsayed, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

July 1, 2024

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations