Idiopathic ScoliosisNCT05404620
Effects of Schroth Method and Proprioceptive Neuromuscular Facilitation Technique in Patients With Idiopathic Scoliosis
A study testing Schroth exercises and PNF technique in people with Idiopathic Scoliosis, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Schroth exercises and PNF technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants with Lenke curve type 1 scoliosis and other types of scoliotic curve magnitude will be included.
- Cobb angle 10-30
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
GOVT EYE-CUM general hospital (THQ), Gojra
Gojra, Punjab Province, 56000
Muhammad Salman Bashir, PhD, +923334497959, salman.bashir@riphah.edu.pk
Fazila Ramzan, MSPT-OM
About this study
Official title: 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.
Read the 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
- Conditions
- Idiopathic Scoliosis
- Being tested
- Schroth exercises, PNF technique
- Keywords
- idiopathic scoliosis, schroth method, proprioceptive neuromuscular facilitation techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth exercisesOther
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.
PNF techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PNF technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3rd week
Goniometer for range of motion
It will be used to measure flexion, extension, and lateral flexion of the spine.
Measured: 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.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study startJun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404620
- Sponsor's protocol ID
- REC/RCR & AHS/22/0121
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29435499Lee 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.
PubMed 27821972Stepien 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.
PubMed 28905003BECKERS 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.
PubMed 34982433Kocaman 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.
PubMed 33857180Burger 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.
PubMed 31206094Lee 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.
PubMed 32675606Kuru 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.
PubMed 25780260Lee 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.
PubMed 28119879
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Schroth Method and Proprioceptive Neuromuscular Facilitation Technique on Pain, Mobility and Quality of Life in Patients With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05404620
- Acronym / sponsor ID
- REC/RCR & AHS/22/0121
- Conditions
- Idiopathic Scoliosis
- Keywords
- idiopathic scoliosis, schroth method, proprioceptive neuromuscular facilitation techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schroth exercises | Experimental | Other: Schroth exercisesMobilization 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. |
| PNF technique | Experimental | Other: PNF techniqueThis 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. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants with Lenke curve type 1 scoliosis and other types of scoliotic curve magnitude will be included.
- Cobb angle 10-30
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schroth exercises9 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. | Other | Schroth exercises |
| PNF technique9 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. | Other | PNF technique |
Primary outcome
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).
Goniometer for range of motion
Time frame: 3rd week
It will be used to measure flexion, extension, and lateral flexion of the spine.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 29435499Negrini 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.
- Background: PubMed 27821972Lee 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.
- Background: PubMed 28905003Stepien 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.
- BackgroundBECKERS DB. PNF in practice: an illustrated guide: SPRINGER-VERLAG BERLIN AN; 2020.
- Background: PubMed 34982433Mohamed 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.
- Background: PubMed 33857180Kocaman 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.
- Background: PubMed 31206094Burger 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.
- BackgroundLee 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: PubMed 32675606Liu 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.
- Background: PubMed 25780260Kuru 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.
- Background: PubMed 28119879Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Salman Bashir, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schroth exercises and PNF technique in people with Idiopathic Scoliosis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS for pain (time frame: 3rd week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404620, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.