NCT05404620

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 31, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

idiopathic scoliosisschroth methodproprioceptive neuromuscular facilitation techniques

Outcome Measures

Primary Outcomes (3)

  • NPRS for pain

    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

    It will be used to measure flexion, extension, and lateral flexion of the spine.

    3rd week

  • SRS-22 questionnaire for quality of life

    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

Study Arms (2)

Schroth exercises

EXPERIMENTAL

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.

Other: Schroth exercises

PNF technique

EXPERIMENTAL

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.

Other: PNF technique

Interventions

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.

Schroth exercises

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.

PNF technique

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants with Lenke curve type 1 scoliosis and other types of scoliotic curve magnitude will be included.
  • Cobb angle 10-30

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOVT EYE-CUM general hospital (THQ), Gojra

Gojra, Punjab Province, 56000, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 29435499BACKGROUND
  • 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. doi: 10.1589/jpts.28.2975. Epub 2016 Oct 28.

    PMID: 27821972BACKGROUND
  • 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.

    PMID: 28905003BACKGROUND
  • BECKERS DB. PNF in practice: an illustrated guide: SPRINGER-VERLAG BERLIN AN; 2020.

    BACKGROUND
  • 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.

    PMID: 34982433BACKGROUND
  • 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.

    PMID: 33857180BACKGROUND
  • 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.

    PMID: 31206094BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32675606BACKGROUND
  • 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.

    PMID: 25780260BACKGROUND
  • 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.

    PMID: 28119879BACKGROUND

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

June 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations