- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404620
Effects of Schroth Method and Proprioceptive Neuromuscular Facilitation Technique in Patients With Idiopathic Scoliosis
May 31, 2022 updated by: Riphah International University
Comparative Effects of Schroth Method and Proprioceptive Neuromuscular Facilitation Technique on Pain, Mobility and Quality of Life in Patients With Idiopathic Scoliosis
The aim of this study is to compare the effects of schroth method and proprioceptive neuromuscular facilitation techniques on pain, mobility, and quality of life in patients with idiopathic scoliosis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Scoliosis is a three-dimensional deformity that causes the spine to curve sideways.
The most common type of scoliosis is "idiopathic," which means the exact cause is unknown.
It accounts for approximately 85% of cases.
The prevalence rate of 2-5% with a Cobb angle greater than 10 degrees.
All previous studies in which schroth method with other different techniques has been performed have shown greater improvement in the management of scoliosis.
However, there is no clinical significance work on the Comparative effect of the schroth method and PNF.
Previous literature showed no significant improvement in mobility and quality of life.
This study aims to find evidence of clinical significance work on effects of Schroth method and proprioceptive neuromuscular facilitation technique on pain, mobility, and quality of life in patients with idiopathic scoliosis in both gender
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Gojra, Punjab, Pakistan, 56000
- GOVT EYE-CUM general hospital (THQ), Gojra
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Contact:
- Muhammad Salman Bashir, PhD
- Phone Number: +923334497959
- Email: salman.bashir@riphah.edu.pk
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Principal Investigator:
- Fazila Ramzan, MSPT-OM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with Lenke curve type 1 scoliosis and other types of scoliotic curve magnitude will be included.
- Cobb angle 10-30
Exclusion Criteria:
- Participants with any surgical and traumatic history of spine
- Participants prescribed with brace treatment
- Subjects with Non-idiopathic scoliosis
- Subjects with any systematic disease e.g. (cardiovascular, vestibular, rheumatological, neuromuscular and pulmonary disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Schroth exercises
Mobilization in the spine between ribs will be performed to increase the mobility of joints.
To strengthen the muscles such as erector spinae, iliopsoas, and the quadratus lumborum, muscle activation will be done.
Then the four exercises of the Schroth method which are the "50 x Swiss ball" exercise, Prone exercise, Sail exercise, and the Muscle-cylinder exercise will be performed.
This will be followed by hot pack and static stretching of muscles.
|
9 participants will perform Schroth exercises with 2 mint rest between each exercise.
+ Hot pack (10 mint) +static stretching of the involved muscles with 10 to 30-sec hold and 2 to 4 repetitions as a standard treatment.
A total of 45 min sessions three times a week on alternate days for three weeks will be provided.
|
|
Experimental: PNF technique
This technique involves the specific program and pattern of PNF that are deep breathing, pelvic posterior tilting, DI flexion & Extension of UL and D2 flexion, and extension of LL. + Hot pack + static stretching of the involved muscles.
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9 participants will perform PNF techniques followed by a hot pack for 10 minutes and static stretching of the involved muscles with 10 to 30-sec hold and 2 to 4 repetitions as a standard treatment.
A total of 45 min sessions three times a week on alternate days for three weeks will be given.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS for pain
Time Frame: 3rd week
|
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
|
3rd week
|
|
Goniometer for range of motion
Time Frame: 3rd week
|
It will be used to measure flexion, extension, and lateral flexion of the spine.
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3rd week
|
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SRS-22 questionnaire for quality of life
Time Frame: 3rd week
|
It includes five domains: self-image, function, pain, mental health (five questions each), and satisfaction with treatment (two questions) to assess the quality of life with scoliosis.
|
3rd week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.
- Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Lee HJ, Seong HD, Bae YH, Jang HY, Chae SH, Kim KH, Lee SM. Effect of the Schroth method of emphasis of active holding on Cobb's angle in patients with scoliosis: a case report. J Phys Ther Sci. 2016 Oct;28(10):2975-2978. Epub 2016 Oct 28.
- Stepien A, Fabian K, Graff K, Podgurniak M, Wit A. An immediate effect of PNF specific mobilization on the angle of trunk rotation and the Trunk-Pelvis-Hip Angle range of motion in adolescent girls with double idiopathic scoliosis-a pilot study. Scoliosis Spinal Disord. 2017 Sep 6;12:29. doi: 10.1186/s13013-017-0132-0. eCollection 2017.
- BECKERS DB. PNF in practice: an illustrated guide: SPRINGER-VERLAG BERLIN AN; 2020.
- Mohamed RA, Yousef AM. Impact of Schroth three-dimensional vs. proprioceptive neuromuscular facilitation techniques in adolescent idiopathic scoliosis: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2021 Dec;25(24):7717-7725. doi: 10.26355/eurrev_202112_27618.
- Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.
- Burger M, Coetzee W, du Plessis LZ, Geldenhuys L, Joubert F, Myburgh E, van Rooyen C, Vermeulen N. The effectiveness of Schroth exercises in adolescents with idiopathic scoliosis: A systematic review and meta-analysis. S Afr J Physiother. 2019 Jun 3;75(1):904. doi: 10.4102/sajp.v75i1.904. eCollection 2019.
- Lee H-J, Lee S-M. Effects of Schroth exercise therapy on curvature and body appearance of patients with lumbar idiopathic scoliosis. Physical Therapy Rehabilitation Science. 2020;9(4):230-7.
- Liu D, Yang Y, Yu X, Yang J, Xuan X, Yang J, Huang Z. Effects of Specific Exercise Therapy on Adolescent Patients With Idiopathic Scoliosis: A Prospective Controlled Cohort Study. Spine (Phila Pa 1976). 2020 Aug 1;45(15):1039-1046. doi: 10.1097/BRS.0000000000003451.
- Lee BK. Influence of the proprioceptive neuromuscular facilitation exercise programs on idiopathic scoliosis patient in the early 20s in terms of curves and balancing abilities: single case study. J Exerc Rehabil. 2016 Dec 31;12(6):567-574. doi: 10.12965/jer.1632796.398. eCollection 2016 Dec.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
May 31, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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