Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence
• Intervention / Treatment: Other: Post-operative rehabilitation; Other: Post-operative mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Zilan Bazancir Apaydın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Mehmet Fatih Korkmaz, MD, Inonu University Faculy of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2017
• Primary Completion (Actual): October 20, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; post-operative; early ambulation; posterior fusion surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2017/53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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,
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No