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Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403152
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Zilan Bazancir Apaydın, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Scoliosis; Adolescence Other: Post-operative rehabilitation Other: Post-operative mobilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Turkey
Zilan Bazancir Apaydın
Ankara, Turkey, 06560
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Mehmet Fatih Korkmaz, MD Inonu University Faculy of Medicine
  Study Documents (Full-Text)

Documents provided by Zilan Bazancir Apaydın, Hacettepe University:
Informed Consent Form  [PDF] February 5, 2017

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Responsible Party: Zilan Bazancir Apaydın, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT04403152    
Other Study ID Numbers: 2017/53
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: starting 12 months after publication
Access Criteria: Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zilan Bazancir Apaydın, Hacettepe University:
rehabilitation
post-operative
early ambulation
posterior fusion surgery
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases