- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319702
Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training for Adolescent Spinal Curvature Abnormalities
Clinical Effects of Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training in Adolescents With Spinal Curvature Abnormalities: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the clinical effectiveness of proprioceptive neuromuscular facilitation (PNF) combined with spiral muscle chain training in improving spinal function and posture in adolescents aged 13 to 18 years with spinal curvature abnormalities.
The main questions it aims to answer are:
Does exercise-based intervention improve trunk inclination angle, kyphotic angle, and body balance parameters in adolescents with spinal curvature abnormalities?
Does the combined intervention improve spinal mobility and paraspinal muscle endurance compared with single-intervention approaches?
Does the combined intervention lead to favorable changes in surface electromyography (sEMG) indicators of the paraspinal muscles?
Researchers will compare a PNF therapy group, a spiral muscle chain training group, and a combined PNF plus spiral muscle chain training group to assess differences in trunk inclination angle, kyphotic angle, spinal mobility, paraspinal muscle endurance, and neuromuscular activation outcomes. Body mass index, fat-to-muscle ratio, and other body-composition-related indicators will be analyzed as exploratory post hoc outcomes.
Participants will:
Be assigned to one of three intervention groups: PNF therapy alone, spiral muscle chain training alone, or combined PNF plus spiral muscle chain training.
Participate in supervised exercise training sessions three times per week for 12 weeks.
Undergo pre- and post-intervention assessments, including body composition testing, electronic spinal measurements, and surface electromyography testing.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210023
- The Affiliated High School of Nanjing Normal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 13 to 18 years
- Newly diagnosed with no prior treatment and meeting the diagnostic criteria for spinal curvature abnormalities
- Scoliosis or coronal spinal curvature abnormality determined by poor posture and angle of trunk inclination or angle of trunk rotation of 5° or greater
- Anterior-posterior spinal curvature abnormality determined by poor posture or abnormal spinal side-view assessment, including kyphotic angle less than 20° or greater than 40°
- No prior brace treatment
- No history of spinal surgery
- Able to complete proprioceptive neuromuscular facilitation therapy, spiral muscle chain training, or combined exercise training as required
- Written informed consent obtained from participants and their parents or legal guardians
Exclusion Criteria:
- Menstruating females at the time of assessment
- Metal implants
- History of brace use or prior treatment for spinal curvature abnormalities
- Severe scoliosis, defined as angle of trunk inclination or angle of trunk rotation greater than 13°
- Congenital spinal curvature abnormality
- Neuromuscular disorders
- Respiratory dysfunction
- Any contraindication to exercise
- Any trauma within the previous 6 months
- Any accompanying neurological, rheumatological, or mental health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Proprioceptive Neuromuscular Facilitation (PNF) Therapy
Participants receive proprioceptive neuromuscular facilitation (PNF) therapy as an exercise intervention for abnormal spinal curvature.
Training is conducted 3 times per week (every other day) for 12 weeks.
The PNF protocol includes resisted scapular-pelvic patterns, cervical flexion/extension, trunk chopping/lifting patterns, bilateral upper-limb patterns, and bridge exercises (per PNF schedule).
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Proprioceptive neuromuscular facilitation (PNF) therapy is used as an exercise-based intervention to address abnormal spinal curvature in children with adolescent idiopathic scoliosis. The PNF program includes resisted scapular-pelvic patterns, cervical flexion and extension, trunk diagonal patterns (chopping and lifting), bilateral upper-limb diagonal patterns, and bridge exercises. Training sessions are supervised and conducted three times per week (every other day) for 12 weeks.
Other Names:
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Experimental: Spiral Muscle Chain (SPS) Training
Participants receive spiral stabilizing muscle chain (SPS) training as an exercise intervention for abnormal spinal curvature.
Training is conducted 3 times per week (every other day) for 12 weeks.
The SPS program follows the SPS training schedule (Training 1A-6A, 7C-10C, and stretching component), with planned repetitions/sets and practice time as listed in the protocol schedule.
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Spiral muscle chain (SPS) training is applied as an exercise-based intervention aimed at improving spinal alignment, postural control, and neuromuscular coordination in children with adolescent idiopathic scoliosis. The SPS program consists of spiral stabilization exercises performed with elastic resistance, body positioning control, and stretching components according to a standardized training protocol. Training sessions are supervised and conducted three times per week (every other day) for 12 weeks.
Other Names:
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Experimental: Combined Exercise Therapy
Participants receive a combined program consisting of PNF therapy plus SPS spiral muscle chain training as an exercise intervention for abnormal spinal curvature.
Training is conducted 3 times per week (every other day) for 12 weeks.
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The combined intervention integrates proprioceptive neuromuscular facilitation (PNF) therapy and spiral muscle chain (SPS) training as a comprehensive exercise program for children with adolescent idiopathic scoliosis. Participants perform both PNF and SPS exercise components within each training cycle to target spinal alignment, muscle endurance, and neuromuscular activation. Training sessions are supervised and conducted three times per week (every other day) for 12 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Trunk Tilt Angle (ATI)
Time Frame: Baseline and after 12 weeks of intervention
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Trunk tilt angle (Angle of Trunk Rotation, ATI) measured using an electronic spine assessment device to evaluate changes in spinal asymmetry and trunk alignment.
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Baseline and after 12 weeks of intervention
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Change in Body Balance Parameters
Time Frame: Baseline and after 12 weeks of intervention
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Body balance parameters assessed by electronic spine measurement, including head lateral deviation, shoulder asymmetry, and pelvic tilt.
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Baseline and after 12 weeks of intervention
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Change in Kyphotic Angle (KA)
Time Frame: Baseline and after 12 weeks of intervention
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Kyphotic angle will be measured using an electronic spinal assessment device to evaluate changes in sagittal spinal curvature.
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Baseline and after 12 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Spinal Mobility
Time Frame: Baseline and after 12 weeks of intervention
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Spinal mobility assessed by electronic spine measurement, including lateral flexion, flexion-extension, and rotational range of motion.
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Baseline and after 12 weeks of intervention
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Change in Body Mass Index (BMI)
Time Frame: Baseline and after 12 weeks of intervention
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Body mass index will be calculated from measured height and weight to evaluate changes in body composition and growth-related physical characteristics after the 12-week exercise intervention.
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Baseline and after 12 weeks of intervention
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Change in Fat-to-Muscle Ratio (FMR)
Time Frame: Baseline and after 12 weeks of intervention
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Fat-to-muscle ratio will be derived from body composition testing to evaluate changes in the relative distribution of fat mass and muscle mass after the 12-week exercise intervention.
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Baseline and after 12 weeks of intervention
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Change in Surface Electromyography Parameters
Time Frame: Baseline and after 12 weeks of intervention
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Surface electromyography parameters of the trunk and paraspinal muscles will be assessed, including amplitude-domain and frequency-domain indicators such as integrated electromyography, mean power frequency, and median frequency.
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Baseline and after 12 weeks of intervention
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Change in Trunk Muscle Activation Patterns
Time Frame: Baseline and after 12 weeks of intervention
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Trunk muscle activation patterns will be assessed during standardized functional tasks using surface electromyography to evaluate neuromuscular coordination and activation symmetry of trunk and paraspinal muscles.
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Baseline and after 12 weeks of intervention
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Change in Paraspinal Muscle Endurance
Time Frame: Baseline and after 12 weeks of intervention
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Paraspinal muscle endurance will be assessed using standardized endurance testing, such as the Biering-Sorensen test, to evaluate the sustained contraction capacity of the trunk extensor muscles.
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Baseline and after 12 weeks of intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Xu Y, Feng M, Wu R, Wang Y, Yang Z, Wang Z, Kang Z, Xie L, Liu H. Effect of adding proprioceptive neuromuscular facilitation to conventional physiotherapy on scapular balance and shoulder proprioception in adolescents with idiopathic scoliosis: a randomised controlled trial protocol. BMJ Open. 2025 Nov 19;15(11):e106848. doi: 10.1136/bmjopen-2025-106848.
- Nechvatal P, Hitrik T, Kendrova LD, Macej M. Comparison of the effect of the McKenzie method and spiral stabilization in patients with low back pain: A prospective, randomized clinical trial. J Back Musculoskelet Rehabil. 2022;35(3):641-647. doi: 10.3233/BMR-210055.
- Maruyama T, Kitagawa T, Takeshita K, Mochizuki K, Nakamura K. Conservative treatment for adolescent idiopathic scoliosis: can it reduce the incidence of surgical treatment? Pediatr Rehabil. 2003 Jul-Dec;6(3-4):215-9. doi: 10.1080/13638490310001642748.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Spinal Diseases
- Spinal Curvatures
- Kyphosis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Therapeutics
- Muscle Stretching Exercises
Other Study ID Numbers
- NNU202410016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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