Postoperative Rehabilitation or Mobilization After Scoliosis Surgery
Primary Purpose
Scoliosis Idiopathic, Scoliosis; Adolescence
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Post-operative rehabilitation
Post-operative mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring rehabilitation, post-operative, early ambulation, posterior fusion surgery
Eligibility Criteria
Inclusion Criteria:
- diagnosis of adolescent idiopathic scoliosis,
- underwent posterior spinal fusion surgery,
- Cobb's angle of 45 degrees or above,
- were aged between 10 and 18 years.
Exclusion Criteria:
- diagnosis of neuromuscular or rheumatismal diseases,
- could not comply with the exercise program,
- severe surgery-related pulmonary complications
- complications which would prevent early rehabilitation (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis),
- surgery-related wound infections.
Sites / Locations
- Zilan Bazancir Apaydın
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation group
Mobilization group
Arm Description
This is the study group in whom post-operative rehabilitation was provided for 5 days.
This is the control group in whom post-operative mobilization was provided for 5 days.
Outcomes
Primary Outcome Measures
Pain via Visual Analogue Scale
Change from baseline at 1 week Pain of the patients will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Patients is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 1 week of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Thoracic Mobility Index
Change from baseline at 1 week Thoracic mobility index was measured at the axillar, epigastric and subcostal regions during normal, maximal inspiration and maximal expiration, using a tape measure, baseline,1 week of follow-ups.
Secondary Outcome Measures
Trunk Balance Test
Change from baseline at 1 week Functional reach test was performed to assess the trunk balance. In standing position, the distances of sideways and forward reaches were measured as centimeters,baseline,1 week of followups.
2-minute Walking Test (2MWT)
Change from baseline at 1 week Two-minute walking test (2MWT), the individual was asked to walk at normal pace for two minutes between the marked start and end points on a 30-meter-long corridor. The walking distance was measured in meters and recorded, baseline,1 week of followups.
Scoliosis Research Society-22 (SRS-22)
Change from baseline at 1 week Scoliosis Research Society-22 (SRS-22) questionnaire was used to assess health-related quality of life. The questionnaire assesses pain, self-image, functions, mental health and satisfaction with the treatment. It consists of 22 items, each scored from 1, which is the worst situation, to 5, which is the best situation. The total score ranges from 1 to 5. Patients is asked to answer the questionnaire, baseline, 6 week of follow-ups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04403152
Brief Title
Postoperative Rehabilitation or Mobilization After Scoliosis Surgery
Official Title
Five Days of Intensive Postoperative Rehabilitation is Superior Than Mobilization in Improving Length of Hospitalization and Outcome of Patients Having Scoliosis Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Scoliosis surgery is a major surgery associated with postoperative pain, loss of physical function and pulmonary dysfunction in adolescent idiopathic scoliosis patients (AIS).Despite the advanced, various medical treatment methods of pain applied in the postoperative period, the mean period of hospitalization is 5 to 7 days. The increasing health expenditures over the years have brought along the need for rehabilitation programs conducted in the early term. Although early mobilization has been accepted as a rule of thumb by spinal surgeons in preventing the performance loss and reducing the causes of morbidity in recent years, the investigators could not find any research on postoperative rehabilitation implemented on patients under the supervision of a physiotherapist, following scoliosis surgery. The aim of this study was to compare effect of five days of intensive postoperative rehabilitation and mobilization on length of hospitalization and outcome in patients having scoliosis surgery.
Detailed Description
Following spinal surgeries, patients experienced deep somatic pain and severe reflex spasms of the muscles located in the surgical site. In addition, pulmonary dysfunction could develop due to reduced flexibility of the spine and mobility of the ribs. It is a known fact that cardiopulmonary functions in adolescent idiopathic scoliosis patients may not recover even two years after surgery. After fusion surgeries in patients with scoliosis have shown that the static and dynamic postural control were impaired and that the postural control could recover one year after the surgery. The increasing health expenditures over the years have brought along the need for rehabilitation programs conducted in the early term.
Increased postoperative pain, impaired balance reactions in the short, weak EMG responses of the trunk muscles, decreased pulmonary capacity and increased health costs have necessitated early rehabilitation in patients who had undergone scoliosis surgery. Also, the need for further research on the effects of physiotherapeutic approaches on the aforementioned functional losses has been indicated in several studies.Although early mobilization has been accepted as a rule of thumb by spinal surgeons in preventing the performance loss and reducing the causes of morbidity in recent years, the investigators could not find any research on postoperative rehabilitation implemented on patients under the supervision of a physiotherapist, following scoliosis surgery.
Therefore, based on these findings, the aim of this study was to compare effect of five days of intensive postoperative rehabilitation and mobilization on length of hospitalization and outcome in patients having scoliosis surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis; Adolescence
Keywords
rehabilitation, post-operative, early ambulation, posterior fusion surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation group
Arm Type
Experimental
Arm Description
This is the study group in whom post-operative rehabilitation was provided for 5 days.
Arm Title
Mobilization group
Arm Type
Active Comparator
Arm Description
This is the control group in whom post-operative mobilization was provided for 5 days.
Intervention Type
Other
Intervention Name(s)
Post-operative rehabilitation
Other Intervention Name(s)
rehabilitation
Intervention Description
Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.
Intervention Type
Other
Intervention Name(s)
Post-operative mobilization
Other Intervention Name(s)
mobilization
Intervention Description
Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.
Primary Outcome Measure Information:
Title
Pain via Visual Analogue Scale
Description
Change from baseline at 1 week Pain of the patients will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Patients is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 1 week of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Time Frame
Baseline, 1 week
Title
Thoracic Mobility Index
Description
Change from baseline at 1 week Thoracic mobility index was measured at the axillar, epigastric and subcostal regions during normal, maximal inspiration and maximal expiration, using a tape measure, baseline,1 week of follow-ups.
Time Frame
Baseline, 1 week
Secondary Outcome Measure Information:
Title
Trunk Balance Test
Description
Change from baseline at 1 week Functional reach test was performed to assess the trunk balance. In standing position, the distances of sideways and forward reaches were measured as centimeters,baseline,1 week of followups.
Time Frame
Baseline, 1 week
Title
2-minute Walking Test (2MWT)
Description
Change from baseline at 1 week Two-minute walking test (2MWT), the individual was asked to walk at normal pace for two minutes between the marked start and end points on a 30-meter-long corridor. The walking distance was measured in meters and recorded, baseline,1 week of followups.
Time Frame
Baseline, 1 week
Title
Scoliosis Research Society-22 (SRS-22)
Description
Change from baseline at 1 week Scoliosis Research Society-22 (SRS-22) questionnaire was used to assess health-related quality of life. The questionnaire assesses pain, self-image, functions, mental health and satisfaction with the treatment. It consists of 22 items, each scored from 1, which is the worst situation, to 5, which is the best situation. The total score ranges from 1 to 5. Patients is asked to answer the questionnaire, baseline, 6 week of follow-ups.
Time Frame
Baseline, 6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of adolescent idiopathic scoliosis,
underwent posterior spinal fusion surgery,
Cobb's angle of 45 degrees or above,
were aged between 10 and 18 years.
Exclusion Criteria:
diagnosis of neuromuscular or rheumatismal diseases,
could not comply with the exercise program,
severe surgery-related pulmonary complications
complications which would prevent early rehabilitation (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis),
surgery-related wound infections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Fatih Korkmaz, MD
Organizational Affiliation
Inonu University Faculy of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Zilan Bazancir Apaydın
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 12 months after publication
IPD Sharing Access Criteria
Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,
Learn more about this trial
Postoperative Rehabilitation or Mobilization After Scoliosis Surgery
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