Postoperative Rehabilitation or Mobilization After Scoliosis Surgery
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|ClinicalTrials.gov Identifier: NCT04403152|
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis Idiopathic Scoliosis; Adolescence||Other: Post-operative rehabilitation Other: Post-operative mobilization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking Description:||The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.|
|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|
|Actual Study Start Date :||February 5, 2017|
|Actual Primary Completion Date :||October 20, 2017|
|Actual Study Completion Date :||November 15, 2017|
Experimental: Rehabilitation group
This is the study group in whom post-operative rehabilitation was provided for 5 days.
Other: Post-operative rehabilitation
Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.
Other Name: rehabilitation
Active Comparator: Mobilization group
This is the control group in whom post-operative mobilization was provided for 5 days.
Other: Post-operative mobilization
Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.
Other Name: mobilization
- Pain via Visual Analogue Scale [ Time Frame: Baseline, 1 week ]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 [ Time Frame: Baseline, 1 week ]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.
- Trunk Balance Test [ Time Frame: Baseline, 1 week ]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) [ Time Frame: Baseline, 1 week ]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) [ Time Frame: Baseline, 6 week ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403152
|Zilan Bazancir Apaydın|
|Ankara, Turkey, 06560|
|Study Director:||Mehmet Fatih Korkmaz, MD||Inonu University Faculy of Medicine|