Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648005
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Effect of Spinal Manipulative Therapy Combined with Brace in Moderate-severe Grade Adolescent Idiopathic Scoliosis a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Spinal Manipulative Therapy Combined with Brace in Moderate-severe Grade Adolescent Idiopathic Scoliosis a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To determine whether spinal manipulative therapy combined with brace is superior to a control of brace alone in improving spinal deformity and quality of life of moderate-severe grade AIS
Design It is a prospective randomized controlled study Patients who met the inclusion criteria were randomly assigned to either the spinal manipulative therapy combined brace group SMTB or the Brace group All participants were prescribed with a GBW brace and the spinal manipulative regimen was provided to the subjects in the SMBT group Cobb angle angle of trunk rotation ATR quality of life SRS-22 progression rates and surgical rates of the subjects were measured at baseline to the 12-month follow-up
Design It is a prospective randomized controlled study Patients who met the inclusion criteria were randomly assigned to either the spinal manipulative therapy combined brace group SMTB or the Brace group All participants were prescribed with a GBW brace and the spinal manipulative regimen was provided to the subjects in the SMBT group Cobb angle angle of trunk rotation ATR quality of life SRS-22 progression rates and surgical rates of the subjects were measured at baseline to the 12-month follow-up
Detailed Description:
Introduction Adolescent idiopathic scoliosis AIS is a complex three-dimensional deformity of the spine that primarily affects children and adolescents It is characterized by coronal scoliosis sagittal imbalance and horizontal rotation of the spine The global prevalence of AIS is estimated to be around 2-3 with a higher proportion of female patients Moderate-severe grade AIS may lead to physical deformities including razorback shoulder imbalance and chest deformity and even affect cardiopulmonary function and irreversible damage to nerves In addition patients with AIS are often associated with moderate to severe psychological disorders Research has confirmed that if left untreated approximately 60 of individuals with moderate-severe AIS will experience progression of their scoliosis Moreover about 30 moderate-severe AIS will suffer from physical deformities chronic pain and psychosocial disorders such as anxiety and depression during adulthood
AIS is classified into three categories based on the extent of spinal curvature measured by the Cobb angle mild ampamplt20 moderate 20-40 and severe ampampgt40 Current guidelines such as the 2016 SOSORT guidelines 8 recommend the primary treatment regimen for moderate AIS to consist of bracing therapy and rehabilitative exercises This regimen aims to reduce pain improve posture and control further progression of scoliosis ultimately aiming to avoid surgery However in clinical practice prolonged bracing alone can have negative impacts on growth and development including pressure sores back pain decreased respiratory function and potential mental health issues
It is now generally accepted that severe-grade AIS with skeletally immature need to undergo surgical corrective surgery But this approach involves relatively high-cost issues and risk of complications due to the invasive complex nature of the procedure As a result of these problems some patients with AIS who are considered to be surgical candidates as well as their parents expressly resist surgery and seek more aggressive conservative treatment In recent years more and more reports in the literature have shown that conservative treatment still has a certain therapeutic effect on AIS ampampgt40 35-91But this efficacy is affected by a number of risk factors There is still a need to explore an active conservative treatment for AIS aims to correct scoliosis avoid surgery
Spinal manipulative therapy SMT as a complementary and alternative therapy for AIS is a skilled hand manipulative technique including massage chiropractic osteopathy and Tuina traditional Chinese manipulation Extensive research has demonstrated its effectiveness in reducing pain decreasing scoliosis angle and improving overall quality of life in patients with AIS Our team has also observed the corrective effect of SMT on moderate-grade AIS in the clinic beforehand
However what needs to be acknowledged is that existing research on the efficacy of SMT for AIS is hampered by the heterogeneity of clinical research protocols and the lack of high-quality randomized controlled trials RCTs To ensure consistency in the application of SMT and to obtain more reliable evidence of its efficacy in the clinical management of AIS our team conducted this RCT to observe the effect of SMT on improving spinal deformity and quality of life in patients with moderate-severe AIS
Methods Trial design This study employed a randomized controlled clinical trial design employing a 11 allocation ratio to assign participants either to the intervention group receiving spinal manipulative therapy combined with brace SMTB or the control group receiving brace Patient enrollment commenced in January 2022 and follow-up treatment concluded in December 2023 The study strictly adhered to the CONSORT guidelines and ethical approval was obtained from the Ethics Committee of the First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine 2022-K-380-01 Furthermore the study protocol was registered with ClinicalTrialsgov ChiCTR2200057023
Participants The participants who fulfilled the subject selection criteria were all enrolled from Scoliosis Treatment Centre of The First Affiliated Hospital of Zhejiang Chinese Medical University The target population for this study was those with moderate-severe grade AIS who met the comprehensive inclusion criteria recommended by the Scoliosis Research Society SRS and the Society on Scoliosis Orthopedic and Rehabilitation Treatment SOSORT 1 10-18 years old 2 primary curve magnitude 20-60 Cobb angle 3 signing informed consent and cooperating with treatment and follow-ups The subjects with neuromuscular rheumatic cardiovascular pulmonary congenital spine-related disorders psychiatric problems or a history of spinal surgery were excluded from the study
Intervention Upon enrollment subjects in SMTB group and Brace group were all prescribed a brace with reference to the 2016 SOSORT guidelines and received preliminary assessment for brace design and fabrication at their first visit Subjects were requested to wear orthosis 23 hrsd and 1 hr for personal hygiene and exercise activities The subjects were treated for 12 months In addition interview for compliance was launched when the subjects came to the scoliosis clinic for follow-up visits
Besides bracing the SMTB group was treated with spinal manipulative therapy If discomfort occurs the investigators will stop the treatment immediately Spinal manipulation is performed twice a week Two doctors with 10 years of clinical experience will perform all examinations and manipulations Intensive training was given to the physiotherapists in spinal manipulation The doctors took the medical history of all participants and performed a clinical examination
1 Finger-pressing manipulation Subjects were kept in the prone position Continuous pressure is applied to the treated section using manipulatorampamp39s own thumb to relax the thoracic vertebra concave side muscle groups It takes 5 minutesFigure 1 finger-pressing manipulation
2 Elbow-pressing manipulation Subjects were kept in the prone position Continuous pressure is applied to the treated section using manipulatorampamp39s elbow to relax the lumbar vertebra concave side muscle groups It takes 5 minutesFigure 2 Elbow-pressing manipulation
3 Thoracic vertebra pulling manipulation Take the left thoracic curve as an example The patient was placed in a sitting position with his left hand resting on his neck and his left elbow bent The operatorampamp39s left hand was passed through the patientampamp39s left elbow and placed on top of the patientampamp39s left hand with the right hand gripping the patientampamp39s left upper arm The operatorampamp39s right hand was pulled upward for pulling the thoracic vertebrae sometimes with localized joint poppingFigure 3 Thoracic vertebra pulling manipulation
4 Lumbar oblique-rotation- pulling manipulation Take the left lumbar curve as an example The patient was placed in the left lateral decubitus position The surgeon stands to the left of the patient The right hand was placed on the right shoulder of the patient to fix the right shoulder The left hand was placed on the patientampamp39s right pelvis for fixation The surgeon rotated the patientampamp39s lumbar spine to its maximum The left hand is rotated ventrally and pulled down to create a momentary force sometimes with localized joint popping Figure 4 Lumbar oblique-rotation- pulling manipulation
Compliance supervision To promote subject cooperation the subjects and their parents will be educated before treatment about the risk of progression of scoliosis its harmfulness and the necessity for treatment When a subjects compliance begins to falter their parents will be encouraged to encourage the subjects to continue training
Outcomes General patient characteristics collected at baseline included agey sexfemale male weightkg heightcm body mass index BMIkgm2 risser grade and location of the major curvethoracic thoracolumbar lumbar Assessments were performed at baseline and after 3 6 12 months of treatment for each patient The final measurements were taken 24 hours after removal of the brace Cobb angle trunk rotation angle ATR and quality of life of the participants were assessed by the same researcher who conducted the interviews
Body mass index BMI is a statistical index using a personampamp39s weight and height to provide an estimate of body fat in males and females of any age It is calculated by taking a personampamp39s weight in kilograms divided by their height in meters squared or BMI weight in kg height2 in m2 The number generated from this equation is then the individualampamp39s BMI number
Risser grade is a staging system of bone maturity based on the ossification of the iliac apophysis ranging from 0 to 5 with higher grades indicating Greater maturity
Location of the major curve judgement according to the location of the apex thoracic apex between T2 and T11 thoracolumbar apex in T12 or L1 and lumbar apex between L2 and L4
The primary outcome measure was the curve reduction of 6 or more treatment success or curve reduction of less than 6 seen on pretherapy and post-treatment posteroanterior standing radiographs compared with the inclusion radiograph treatment failure
Radiographic measurements were conducted through radiographic images in the Digital Imaging and Communications in Medicine image format using the picture archiving and communication system version 231 clinical imaging tool Sectra PACS
A range of secondary outcomes were measured which was scoliosis related Cobb angle is the gold standard for evaluating the degree of scoliosis Measurement of Cobb angle was carried out at baseline and after 12-month of treatment and changes in its degree were observed to determine whether the scoliosis had improved or progressed
ATR was measured using the Bunnells sociometer in a standing forward flexed position which is considered to be sensitive specific and reliable The greater the angle the more pronounced the razorback and the worse the subjectampamp39s posture The ATR was collected at baseline and after 3 6 12month of treatment
The Scoliosis Research Society-22 SRS-22 questionnaire used to assess health-related quality of life is a simple yet practical questionnaire currently available for AIS with good validity and retest reliability for clinical application It consists of five dimensions function pain self-image mental health five questions each and satisfaction with treatment two questions for a total of 22 questions each rated from 1 worst to 5 best The higher the score the better the subjectampamp39s quality of life This questionnaire was assessed at subject enrollment and after 6 12month of treatment
Randomization and Blinding A random number sequence was generated by SPSS Statistics version 230 IBM Corp and used to completely randomize the included all patients into groups They were divided into intervention and control groups The grouping information was made into a randomization card and kept in sequentially numbered and opaque envelopes The doctor in charge of treatment opened the envelopes to obtain the grouping code according to the order in which the patients were enrolled Due to the specificity of the manipulation this study could not be blinded to subjects and clinicians but researchers who assessed efficacy and analyzed the data were blinded to treatment assignment
Safety monitoring and adverse events All expected or unexpected adverse events from this study will be recorded and monitored Patients suffered from any adverse events related to this study will also receive free treatment There will be a fast channel for the emergency or abnormal sensations requiring the clinicians intervention
Statistical analysis When calculating the sample size the response rate was taken as the primary indicator for assessing the efficacy of manipulation in patients who with AIS Based on data from and the pre-test results the control group effectiveness was 680 whereas it was anticipated that the treatment group effectiveness would achieve 895 By utilizing the PASS software version 15 and setting an alpha level of 005 and power 1-β of 080 it was determined that a minimum of 106 subjects per group was necessary Taking into account 12 months of continuous treatment and potential losses it was ultimately decided to include 118 subjects per group
All primary analyses were conducted according to the intention-to-treat principle The investigators did efficacy analyses in the full analysis set and per protocol set which included all randomized patients who received at least one session of treatment and had at least one efficacy measureThe primary analysis population included all patients with Cobb angle data reported within the time window defined in the protocol -4 week to 0 weeks around the 12-month post-randomization follow-up timepoint A sensitivity analysis was performed comparing the intention to treat analysis data against per-protocol data exclusively from patients who complied with the study protocol
The investigators did safety analyses in the safety set which included all randomized patients who received at least one session of spinal manipulative therapy or brace
All statistical analyses were performed using SPSS statistics version 230 IBM Corp Continuous and discrete parameters were measured using parametric or nonparametric tests for group comparisons The Shapiro-Wilks test was used to test the normality of each study parameter Independent t-test was used for comparison between groups and paired t-test for comparison within groups Meanwhile the chi-square test was used for comparison between groups for count data The statistical significance level was set at Pampamplt005
All statistical analyses of the primary outcome were conducted by 2 independent statisticians who were blinded to intervention and assigned to each patient participating in the study
Patient and public involvement No patients were involved in the design or conduct of the study in setting the research question or in determining the outcome measures of this study nor did they have any input on data analysis interpretation or writing up of results
AIS is classified into three categories based on the extent of spinal curvature measured by the Cobb angle mild ampamplt20 moderate 20-40 and severe ampampgt40 Current guidelines such as the 2016 SOSORT guidelines 8 recommend the primary treatment regimen for moderate AIS to consist of bracing therapy and rehabilitative exercises This regimen aims to reduce pain improve posture and control further progression of scoliosis ultimately aiming to avoid surgery However in clinical practice prolonged bracing alone can have negative impacts on growth and development including pressure sores back pain decreased respiratory function and potential mental health issues
It is now generally accepted that severe-grade AIS with skeletally immature need to undergo surgical corrective surgery But this approach involves relatively high-cost issues and risk of complications due to the invasive complex nature of the procedure As a result of these problems some patients with AIS who are considered to be surgical candidates as well as their parents expressly resist surgery and seek more aggressive conservative treatment In recent years more and more reports in the literature have shown that conservative treatment still has a certain therapeutic effect on AIS ampampgt40 35-91But this efficacy is affected by a number of risk factors There is still a need to explore an active conservative treatment for AIS aims to correct scoliosis avoid surgery
Spinal manipulative therapy SMT as a complementary and alternative therapy for AIS is a skilled hand manipulative technique including massage chiropractic osteopathy and Tuina traditional Chinese manipulation Extensive research has demonstrated its effectiveness in reducing pain decreasing scoliosis angle and improving overall quality of life in patients with AIS Our team has also observed the corrective effect of SMT on moderate-grade AIS in the clinic beforehand
However what needs to be acknowledged is that existing research on the efficacy of SMT for AIS is hampered by the heterogeneity of clinical research protocols and the lack of high-quality randomized controlled trials RCTs To ensure consistency in the application of SMT and to obtain more reliable evidence of its efficacy in the clinical management of AIS our team conducted this RCT to observe the effect of SMT on improving spinal deformity and quality of life in patients with moderate-severe AIS
Methods Trial design This study employed a randomized controlled clinical trial design employing a 11 allocation ratio to assign participants either to the intervention group receiving spinal manipulative therapy combined with brace SMTB or the control group receiving brace Patient enrollment commenced in January 2022 and follow-up treatment concluded in December 2023 The study strictly adhered to the CONSORT guidelines and ethical approval was obtained from the Ethics Committee of the First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine 2022-K-380-01 Furthermore the study protocol was registered with ClinicalTrialsgov ChiCTR2200057023
Participants The participants who fulfilled the subject selection criteria were all enrolled from Scoliosis Treatment Centre of The First Affiliated Hospital of Zhejiang Chinese Medical University The target population for this study was those with moderate-severe grade AIS who met the comprehensive inclusion criteria recommended by the Scoliosis Research Society SRS and the Society on Scoliosis Orthopedic and Rehabilitation Treatment SOSORT 1 10-18 years old 2 primary curve magnitude 20-60 Cobb angle 3 signing informed consent and cooperating with treatment and follow-ups The subjects with neuromuscular rheumatic cardiovascular pulmonary congenital spine-related disorders psychiatric problems or a history of spinal surgery were excluded from the study
Intervention Upon enrollment subjects in SMTB group and Brace group were all prescribed a brace with reference to the 2016 SOSORT guidelines and received preliminary assessment for brace design and fabrication at their first visit Subjects were requested to wear orthosis 23 hrsd and 1 hr for personal hygiene and exercise activities The subjects were treated for 12 months In addition interview for compliance was launched when the subjects came to the scoliosis clinic for follow-up visits
Besides bracing the SMTB group was treated with spinal manipulative therapy If discomfort occurs the investigators will stop the treatment immediately Spinal manipulation is performed twice a week Two doctors with 10 years of clinical experience will perform all examinations and manipulations Intensive training was given to the physiotherapists in spinal manipulation The doctors took the medical history of all participants and performed a clinical examination
1 Finger-pressing manipulation Subjects were kept in the prone position Continuous pressure is applied to the treated section using manipulatorampamp39s own thumb to relax the thoracic vertebra concave side muscle groups It takes 5 minutesFigure 1 finger-pressing manipulation
2 Elbow-pressing manipulation Subjects were kept in the prone position Continuous pressure is applied to the treated section using manipulatorampamp39s elbow to relax the lumbar vertebra concave side muscle groups It takes 5 minutesFigure 2 Elbow-pressing manipulation
3 Thoracic vertebra pulling manipulation Take the left thoracic curve as an example The patient was placed in a sitting position with his left hand resting on his neck and his left elbow bent The operatorampamp39s left hand was passed through the patientampamp39s left elbow and placed on top of the patientampamp39s left hand with the right hand gripping the patientampamp39s left upper arm The operatorampamp39s right hand was pulled upward for pulling the thoracic vertebrae sometimes with localized joint poppingFigure 3 Thoracic vertebra pulling manipulation
4 Lumbar oblique-rotation- pulling manipulation Take the left lumbar curve as an example The patient was placed in the left lateral decubitus position The surgeon stands to the left of the patient The right hand was placed on the right shoulder of the patient to fix the right shoulder The left hand was placed on the patientampamp39s right pelvis for fixation The surgeon rotated the patientampamp39s lumbar spine to its maximum The left hand is rotated ventrally and pulled down to create a momentary force sometimes with localized joint popping Figure 4 Lumbar oblique-rotation- pulling manipulation
Compliance supervision To promote subject cooperation the subjects and their parents will be educated before treatment about the risk of progression of scoliosis its harmfulness and the necessity for treatment When a subjects compliance begins to falter their parents will be encouraged to encourage the subjects to continue training
Outcomes General patient characteristics collected at baseline included agey sexfemale male weightkg heightcm body mass index BMIkgm2 risser grade and location of the major curvethoracic thoracolumbar lumbar Assessments were performed at baseline and after 3 6 12 months of treatment for each patient The final measurements were taken 24 hours after removal of the brace Cobb angle trunk rotation angle ATR and quality of life of the participants were assessed by the same researcher who conducted the interviews
Body mass index BMI is a statistical index using a personampamp39s weight and height to provide an estimate of body fat in males and females of any age It is calculated by taking a personampamp39s weight in kilograms divided by their height in meters squared or BMI weight in kg height2 in m2 The number generated from this equation is then the individualampamp39s BMI number
Risser grade is a staging system of bone maturity based on the ossification of the iliac apophysis ranging from 0 to 5 with higher grades indicating Greater maturity
Location of the major curve judgement according to the location of the apex thoracic apex between T2 and T11 thoracolumbar apex in T12 or L1 and lumbar apex between L2 and L4
The primary outcome measure was the curve reduction of 6 or more treatment success or curve reduction of less than 6 seen on pretherapy and post-treatment posteroanterior standing radiographs compared with the inclusion radiograph treatment failure
Radiographic measurements were conducted through radiographic images in the Digital Imaging and Communications in Medicine image format using the picture archiving and communication system version 231 clinical imaging tool Sectra PACS
A range of secondary outcomes were measured which was scoliosis related Cobb angle is the gold standard for evaluating the degree of scoliosis Measurement of Cobb angle was carried out at baseline and after 12-month of treatment and changes in its degree were observed to determine whether the scoliosis had improved or progressed
ATR was measured using the Bunnells sociometer in a standing forward flexed position which is considered to be sensitive specific and reliable The greater the angle the more pronounced the razorback and the worse the subjectampamp39s posture The ATR was collected at baseline and after 3 6 12month of treatment
The Scoliosis Research Society-22 SRS-22 questionnaire used to assess health-related quality of life is a simple yet practical questionnaire currently available for AIS with good validity and retest reliability for clinical application It consists of five dimensions function pain self-image mental health five questions each and satisfaction with treatment two questions for a total of 22 questions each rated from 1 worst to 5 best The higher the score the better the subjectampamp39s quality of life This questionnaire was assessed at subject enrollment and after 6 12month of treatment
Randomization and Blinding A random number sequence was generated by SPSS Statistics version 230 IBM Corp and used to completely randomize the included all patients into groups They were divided into intervention and control groups The grouping information was made into a randomization card and kept in sequentially numbered and opaque envelopes The doctor in charge of treatment opened the envelopes to obtain the grouping code according to the order in which the patients were enrolled Due to the specificity of the manipulation this study could not be blinded to subjects and clinicians but researchers who assessed efficacy and analyzed the data were blinded to treatment assignment
Safety monitoring and adverse events All expected or unexpected adverse events from this study will be recorded and monitored Patients suffered from any adverse events related to this study will also receive free treatment There will be a fast channel for the emergency or abnormal sensations requiring the clinicians intervention
Statistical analysis When calculating the sample size the response rate was taken as the primary indicator for assessing the efficacy of manipulation in patients who with AIS Based on data from and the pre-test results the control group effectiveness was 680 whereas it was anticipated that the treatment group effectiveness would achieve 895 By utilizing the PASS software version 15 and setting an alpha level of 005 and power 1-β of 080 it was determined that a minimum of 106 subjects per group was necessary Taking into account 12 months of continuous treatment and potential losses it was ultimately decided to include 118 subjects per group
All primary analyses were conducted according to the intention-to-treat principle The investigators did efficacy analyses in the full analysis set and per protocol set which included all randomized patients who received at least one session of treatment and had at least one efficacy measureThe primary analysis population included all patients with Cobb angle data reported within the time window defined in the protocol -4 week to 0 weeks around the 12-month post-randomization follow-up timepoint A sensitivity analysis was performed comparing the intention to treat analysis data against per-protocol data exclusively from patients who complied with the study protocol
The investigators did safety analyses in the safety set which included all randomized patients who received at least one session of spinal manipulative therapy or brace
All statistical analyses were performed using SPSS statistics version 230 IBM Corp Continuous and discrete parameters were measured using parametric or nonparametric tests for group comparisons The Shapiro-Wilks test was used to test the normality of each study parameter Independent t-test was used for comparison between groups and paired t-test for comparison within groups Meanwhile the chi-square test was used for comparison between groups for count data The statistical significance level was set at Pampamplt005
All statistical analyses of the primary outcome were conducted by 2 independent statisticians who were blinded to intervention and assigned to each patient participating in the study
Patient and public involvement No patients were involved in the design or conduct of the study in setting the research question or in determining the outcome measures of this study nor did they have any input on data analysis interpretation or writing up of results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None