Protocol summary
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Study aim
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The Effect of Multimedia Training on Pain Intensity, Depression and Catastrophizing in Patients with Chronic Low Back Pain
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Design
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Clinical trials with two intervention and blind group, double-blind, control group with parallel, randomized, community-based, and pragmatic groups
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Settings and conduct
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The researcher will complete the questionnaire by referring to clinics in Fasa. Patients will be randomly assigned into two intervention and control groups. In the multimedia tutorial group, seven cd films will be provided to patients over seven weeks, but face-to-face tutorials will be delivered through lectures, question and answer, and slides. At the end of 7 sessions and one month after the intervention, the questionnaires will be completed again by the patients. No training is given in the control group. This is a double-blind clinical trial.
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Participants/Inclusion and exclusion criteria
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Including criteria: Age more than 18 years, Chronic lower back pain with expert diagnosis, Depression score higher than 14
Exclusion criteria: Unwillingness to participate in the study, Other chronic underlying diseases
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Intervention groups
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Multimedia education group and face to face training group
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Main outcome variables
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Pain intensity; Depression; Catastrophic
General information
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Reason for update
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Based on a review of recent studies and a recent study done by the research project manager, the researchers have decided to consider catastrophizing and depression as secondary outcomes in the present research project.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180313039074N1
Registration date:
2018-03-21, 1397/01/01
Registration timing:
prospective
Last update:
2022-02-22, 1400/12/03
Update count:
1
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Registration date
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2018-03-21, 1397/01/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-09, 1397/01/20
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Expected recruitment end date
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2018-09-21, 1397/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of multimedia training on pain management on the severity of pain, depression and catastrophic in patients with non-specific chronic low back pain.
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Public title
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A survey of multimedia education on severity of pain, depression and catastrophizing in patients with chronic low back pain.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age older than 18 years
Possibility to attend face to face face-to-face faculty members
Involvement in research on chronic low back pain based on expert diagnosis based on physical examinations and diagnostic tests such as MRI, CT scan and imaging
Ability and use of educational CDs in patients with multimedia training
Inclination to participate in research
Having a depression score higher than 14 according to the Beck Depression Inventory
Exclusion criteria:
Unwillingness or the possibility of continuing to participate in the study for any reason (such as the severity of the pain of the patient), but also to other chronic pain such as chronic headache - chronic psychiatric disorders such as schizophrenia - participation in similar training classes - lack of participation in more than twoEducational session
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, patients will be selected by available sampling method. Then, eligible patients will be assigned face-to-face and face-to-face training using random numbers in three groups of multimedia tutorials. As perpendiculars A represent multimedia tutorials, B represents a face-to-face education group and C represents a control group that will have six different modes; for example:
(1-AABBcc, 2-ABcABc, ..., 6-ABccBA
Then, to select the sample individuals, we move our finger randomly from a random point table in the direction of a row or column. Whenever there are numbers between one and six, the permutation is related to that number. For example, if number 6 arrives, the permutation of the ABCCBA is written down so that qualified patients are placed in three groups of multimedia education, face-to-face and control. The selection of permutations is repeated 15 times, so that 99 patients are assigned to three equal groups
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study blind people will be involved with study participants and analysts who will do the study analysis.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-03-28, 1396/01/08
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Ethics committee reference number
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IR-SUMS.REC.1396.117
Health conditions studied
1
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Description of health condition studied
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Chronic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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The average intensity of pain during the last 2 weeks
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Timepoint
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Before the intervention, immediately after the intervention (7 training sessions) and one month after the intervention
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Method of measurement
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The average intensity of pain during the last 2 weeks based on the numerical rating scale
Secondary outcomes
1
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Description
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Average pain catastrophizing score
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Timepoint
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Before the intervention, immediately after the intervention (7 training sessions) and one month after the intervention
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Method of measurement
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Pain Catastrophizing Scale
2
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Description
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Average Depression score
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Timepoint
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Before the intervention, immediately after the intervention (7 training sessions) and one month after the intervention
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Method of measurement
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Beck Depression Scale
Intervention groups
1
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Description
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Intervention group 1: Seven educational films will be provided to patients in seven weeks, which will be watched as a CD in the home.Intervention group 2: Face-to-face training, in which the patients fall into groups of 8 to 10 and receive training for seven weeks.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available