Protocol summary
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Study aim
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Effect of massage on chronic nonspecific low back pain in the elderly treated with corrective movements
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Design
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A randomized controlled clinical trial with parallel groups
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Settings and conduct
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Massage is done in each session before starting the movements. In this study, 12 sessions are considered every other day for the presence of each patient in the study to perform corrective movements and massage in the two physiotherapy centers of Novin and Bouali.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
• Elderly patients with nonspecific low back pain ranging in age from 60 to 80 years.
• Not having specific chronic low back pain
• No chronic diseases such as: respiratory, heart disease, malignant tumors, etc.
Exclusion criteria:
• Elderly unwillingness to continue working
• Creating a specific problem that the patient cannot continue to study.
• Missing more than two sessions
• People who have had a lower back pain than they did during the corrective and massage exercises.
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Intervention groups
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Control samples only received corrective movements prescribed by the physiotherapist and the intervention group will receive massage in addition to the corrective exercises by the researcher who trained the massage before study or by the trained assistant.
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Main outcome variables
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Measurement of LBP and pain assessment in pre and post intervention and one month after intervention
General information
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Reason for update
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Enter the end time of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200125046246N1
Registration date:
2020-04-09, 1399/01/21
Registration timing:
registered_while_recruiting
Last update:
2020-08-20, 1399/05/30
Update count:
1
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Registration date
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2020-04-09, 1399/01/21
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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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2019-09-23, 1398/07/01
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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2019-09-28, 1398/07/06
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Actual recruitment end date
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2020-04-13, 1399/01/25
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Trial completion date
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2020-05-29, 1399/03/09
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Scientific title
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Investigating the effect of massage on chronic low back pain in the elderly undergoing corrective movements
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Public title
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The effect of massage on the treatment of low back pain before corrective exercises
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Elderly with nonspecific chronic low back pain ranging in age from 60 to 80 years
According to VAS measurements, their back pain score is greater than 3.
Exclusion criteria:
Lack of respiratory, heart disease, malignant tumors, tuberculosis, cutaneous lesions and severe skin allergies
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Age
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From 60 years old to 80 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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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
67
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization:7 blocks with 10 samples(5 samples in each intervention and control group) by www.sealedenvelop.com
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-09-02, 1398/06/11
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1398.035
Health conditions studied
1
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Description of health condition studied
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Non-specific chronic low back pain
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ICD-10 code
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Dorsalgia
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ICD-10 code description
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M54
Primary outcomes
1
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Description
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The effect of massage on Low back pain score in the Quebec and Vas questionnaire
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Timepoint
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Measurement of LBP before intervention for both sample and control groups and after intervention for both groups
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Method of measurement
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Quebec Back Pain Disability Scale and VAS(visual Analougue Scale)
Secondary outcomes
1
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Description
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Low back pain score
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Timepoint
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Low back pain score 1 month after intervention for both sample and control groups
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Method of measurement
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Quebec Back Pain Disability Scale and VAS(visual Analougue Scale)
Intervention groups
1
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Description
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Intervention group: Receiving 20 minutes of massage by the researcher and in each session for the patient before performing the corrective movements prescribed by the physiotherapist
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Category
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Prevention
2
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Description
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Control group: Physiotherapist received prescription corrective movements in 12 sessions according to intervention group.
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Category
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Prevention
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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Kashan 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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Yes - There is 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
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Title and more details about the data/document
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The informed consent form is used to obtain patient consent to participate in the study, and each patient reads it before entering the study, and if so, signed and entered the study.
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When the data will become available and for how long
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Each patient is studied before entering the study.
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To whom data/document is available
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Supervisor as well as project visitors who rebel on site to monitor the project.
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Under which criteria data/document could be used
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To obtain patients' consent to enter the study and in case of unsatisfactory exit from the study.
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From where data/document is obtainable
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The forms of informed consent are in the hands of the researcher and one is in the hands of the University Research Institute.
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What processes are involved for a request to access data/document
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After completing the titles, the informed consent form is approved by the supervisor and then by the Vice President of Research and multiplied by the number of samples to be completed by the patients.
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Comments
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