Back PainNCT02237105
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
A study testing Cognitive Behavioral Therapy in people with Back Pain, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who intended to undergo spinal surgery
Who cannot join
- patients who does not speak Hebrew language
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir MC
Kfar Saba
Shushan Amir, 09-7472966, linor.amir@clalit.org.il
Linor Shushan Amir, MA
About this study
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.
- Conditions
- Back Pain
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery Receives: Behavioral: Cognitive Behavioral Therapy |
| control group | No intervention | This group will not undergo any psychological intervention before the spinal surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSI questionnaire in spine preoperative patients .
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
Measured: 24 months
OSWESTRY questionnaire in spine preoperative patients
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
Measured: 24 months
SF 36 questionnaire in spine preoperative patients
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
Measured: 24 months
VAS scale in spine preoperative patients
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
Measured: 24 months
Secondary outcomes (4)
BSI questionnaire in spine postoperative patients
assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire
Measured: 24 months
OSWESTRY questionnaire in spine postoperative patients
Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire
Measured: 24 months
SF 36 questionnaire in postoperative patients
Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire
Measured: 24 months
VAS scale in spine postoperative patients
Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237105
- Sponsor's protocol ID
- MMC14276-13CTIL
- Status last verified
- Mar 2016
- First submitted
- 8 Jun 2014
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
- ClinicalTrials.gov ID
- NCT02237105
- Acronym / sponsor ID
- MMC14276-13CTIL
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | Behavioral: Cognitive Behavioral TherapyThis group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery |
| control group | No intervention | –This group will not undergo any psychological intervention before the spinal surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who intended to undergo spinal surgery
Key exclusion criteria (1 listed)
- patients who does not speak Hebrew language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive Behavioral Therapy | Behavioural | Cognitive Behavioral Therapy Group |
Primary outcome
BSI questionnaire in spine preoperative patients .
Time frame: 24 months
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
OSWESTRY questionnaire in spine preoperative patients
Time frame: 24 months
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
SF 36 questionnaire in spine preoperative patients
Time frame: 24 months
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
VAS scale in spine preoperative patients
Time frame: 24 months
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
4 secondary outcomes
BSI questionnaire in spine postoperative patients
Time frame: 24 months
OSWESTRY questionnaire in spine postoperative patients
Time frame: 24 months
SF 36 questionnaire in postoperative patients
Time frame: 24 months
VAS scale in spine postoperative patients
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Back Pain, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSI questionnaire in spine preoperative patients . (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.