The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

Back Pain Clinical Trial

Official title:

The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02237105
• Other study ID #: MMC14276-13CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2014
• Last updated: March 14, 2016
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the outcome of spinal surgery.

The goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style.

The patients in this study will be randomly divided into two groups. One group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a control group, and will not have any psychological intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients who intended to undergo spinal surgery

Exclusion Criteria:

• patients who does not speak Hebrew language

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Cognitive Behavioral Therapy

Locations

Country	Name	City	State
Israel	Meir MC	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BSI questionnaire in spine preoperative patients .	assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire	24 months	No
Primary	OSWESTRY questionnaire in spine preoperative patients	Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire	24 months	No
Primary	SF 36 questionnaire in spine preoperative patients	assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire	24 months	No
Primary	VAS scale in spine preoperative patients	Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale	24 months	No
Secondary	BSI questionnaire in spine postoperative patients	assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire	24 months	No
Secondary	OSWESTRY questionnaire in spine postoperative patients	Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire	24 months	No
Secondary	SF 36 questionnaire in postoperative patients	Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire	24 months	No
Secondary	VAS scale in spine postoperative patients	Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale	24 months	No