Clinical trial NCT04403152: 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
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis Idiopathic
Scoliosis; Adolescence
Keywords: rehabilitation
post-operative
early ambulation
posterior fusion surgery
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain via Visual Analogue Scale
timeFrame: Baseline, 1 week
measure: Thoracic Mobility Index
timeFrame: Baseline, 1 week
Secondary outcomes:
measure: Trunk Balance Test
timeFrame: Baseline, 1 week
measure: 2-minute Walking Test (2MWT)
timeFrame: Baseline, 1 week
measure: Scoliosis Research Society-22 (SRS-22)
timeFrame: Baseline, 6 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zilan Bazancir Apaydın
Study officials:
affiliation: Inonu University Faculy of Medicine
name: Mehmet Fatih Korkmaz, MD
role: STUDY_DIRECTOR
References: