Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

Scoliosis Idiopathic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403152
• Other study ID #: 2017/53
• Status: Completed
• Phase: N/A
• Start date: February 5, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: May 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 15, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. diagnosis of adolescent idiopathic scoliosis,

2. underwent posterior spinal fusion surgery,

3. Cobb's angle of 45 degrees or above,

4. were aged between 10 and 18 years.

Exclusion Criteria:

1. diagnosis of neuromuscular or rheumatismal diseases,

2. could not comply with the exercise program,

3. severe surgery-related pulmonary complications

4. complications which would prevent early rehabilitation (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis),

5. surgery-related wound infections.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

Intervention

Other:
• Post-operative rehabilitation
Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.
• 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.

Locations

Country	Name	City	State
Turkey	Zilan Bazancir Apaydin	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 week
Primary	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.	Baseline, 1 week
Secondary	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.	Baseline, 1 week
Secondary	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.	Baseline, 1 week
Secondary	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.	Baseline, 6 week