Protocol summary
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Study aim
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Comparison of the effect of resistance training with motor skills training and pain reprocessing on pain, performance and quality of life of flight attendants with non-specific chronic back pain
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Design
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A controlled, parallel-group, single-blind, randomized clinical trial on 60 patients.
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Settings and conduct
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Flight attendants with non-specific chronic low back pain who refer to the health and wellness center of Kharazmi University during the study, if they are eligible, will be included in the study and will be randomly assigned to the intervention and control groups using a randomized block method. This study is conducted in a single-blinded manner so that the doctor examining the patients does not know about the type of interventions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: male and female flight attendants with non-specific chronic low back pain between 20 and 40 years old;
Exclusion criteria: history of any surgery and inflammatory diseases in the spine area, history of any musculoskeletal abnormalities in the spine area
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Intervention groups
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Intervention group 1: resistance exercises along with motor skill exercises (24 sessions over 8 weeks)
Intervention group 2: resistance exercises with pain reprocessing (8 sessions over 4 weeks)
Intervention group 3: resistance exercises with motor skill exercises and pain reprocessing (24 sessions over 8 weeks combined with 8 sessions of pain reprocessing over 4 weeks)
Control group:only resistance training (24 sessions over 8 weeks)
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Main outcome variables
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Pain, performance, quality of life, disability, fear of movement, pain catastrophizing, fear-avoidance beliefs, pain self-efficacy, depression, anxiety, stress.
General information
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Reason for update
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Dear all
in order to the fact that the patients collection was not carried out at the specified time due to the large number of patients, the current research needs to change the time of the patient collection.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220804055617N1
Registration date:
2022-12-17, 1401/09/26
Registration timing:
prospective
Last update:
2024-04-30, 1403/02/11
Update count:
2
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Registration date
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2022-12-17, 1401/09/26
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Registrant information
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Recruitment status
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Not yet recruiting
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Funding source
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Expected recruitment start date
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2025-12-20, 1404/09/29
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Expected recruitment end date
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2026-12-31, 1405/10/10
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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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Effectiveness of the resistance exercises with motor skills training and pain reprocessing program on pain, performance, and quality of life in flight attendants with chronic non-specific low back pain
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Public title
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The effect of a psychological-movement-based intervention in individuals with non-specific chronic low back pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male and female flight attendants with non-specific chronic back pain
Male and female flight attendants with an age range of 20-40 years
Exclusion criteria:
History of any surgery and inflammatory diseases in the spine area
History of any musculoskeletal abnormalities in the spine area
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Age
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From 20 years old to 40 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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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using random permuted blocks randomization (16 blocks with size 8), four treatment combinations are independently allocated to participants by1:1:1:1 ratio (after the initial assessment). The random sequence list was generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983), and using (https://www.randomizer.org) This step will be guaranteed by a blind assessor.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessor will be blind to group allocation. Participants will not be blind to the study and grouping; however, they were not aware which treatment will be considered as therapeutic (There is an unavoidable risk of bias in this study where the intervention cannot be blinded to interventionists, patients). Before the evaluation, the necessary training will be given to the outcome assessor in relation to how to measure the outcomes in order to prevent any questions and answers between the assessor and the participants.
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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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2022-07-20, 1401/04/29
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Ethics committee reference number
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IR.SSRC.REC.1401.048
Health conditions studied
1
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Description of health condition studied
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Chronic non-specific 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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Pain
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Visual analogue scale
Secondary outcomes
1
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Description
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Disability
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Roland Morris disability questionnaire
2
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Description
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Kinesiophobia
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Tempa Scale Of Kinesiphobia
3
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Description
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Catastrophizing Pain
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Pain catastrophizing scale
4
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Description
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Fear avoidance beliefs
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Fear avoidance beliefs questionnaire
5
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Description
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Pain self-efficacy
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Pain self-efficacy questionnaire
6
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Description
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Depression
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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DASS questionnaire
7
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Description
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Quality of life
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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The 36-Item quality of life questionnaire
8
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Description
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Performance
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Finger to floor test
9
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Description
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Single Limb Stance
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Single Limb Stance test
10
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Description
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Sitting On Bobath Ball
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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Sitting On Bobath Ball test
11
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Description
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Muscular Endurance
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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McGill's Torso Muscular Endurance Test Battery
12
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Description
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Anxiety
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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DASS questionnaire
13
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Description
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Stress
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Timepoint
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Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
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Method of measurement
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DASS questionnaire
Intervention groups
1
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Description
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First intervention group: people receive resistance exercises along with motor skill exercises. Resistance exercises: It includes exercises for the muscles of the trunk area, which is divided into 3 stages, each stage is gradually more difficult. All patients will begin with Phase 1 exercises. Training will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Motor skills training: will include motor skills training and challenging functional activities that are difficult to perform due to back pain.
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Category
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Rehabilitation
2
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Description
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In the second intervention group: participants receive resistance exercises with pain reprocessing. Resistance exercises: include exercises for the muscles of the trunk area, which are divided into 3 phases, each phase is gradually more difficult. All patients will begin with Phase 1 exercises. Exercises will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Pain reprocessing: involves education aimed at increasing patients' re-perception of primary chronic pain as a false alarm generated by the brain. Pain reprocessing shares concepts and techniques with existing treatments for pain and cognitive behavioral therapy for the fear disorder. Participants will complete 8 sessions of 1-hour individual therapy sessions with an experienced therapist twice weekly for 4 weeks. Techniques include (1) providing personal evidence for focused pain (2) guided reappraisal of pain sensation while sitting and while engaging in fearful situations or movements (3) techniques focusing on psychosocial factors (e.g, depression) that potentially increase pain, and (4) techniques to increase positive emotions and self-compassion.
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Category
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Rehabilitation
3
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Description
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In the third intervention group: participants receive resistance exercises with motor skill exercises and pain reprocessing. Resistance exercises: include exercises for the muscles of the trunk area, which are divided into 3 phases, each phase is gradually more difficult. All patients will begin with Phase 1 exercises. Exercises will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Motor skills training: will include motor skills education and challenging functional activities that are difficult to perform due to low back pain. Pain reprocessing: involves education aimed at increasing patients' re-perception of primary chronic pain as a false alarm generated by the brain. Pain reprocessing shares concepts and techniques with existing treatments for pain and cognitive behavioral therapy for the fear disorder. Participants will complete 8 sessions of 1-hour individual therapy sessions with an experienced therapist twice weekly for 4 weeks. Techniques include (1) providing personal evidence for focused pain (2) guided reappraisal of pain sensation while sitting and while engaging in fearful situations or movements (3) techniques focusing on psychosocial factors (e.g, depression) that potentially increase pain, and (4) techniques to increase positive emotions and self-compassion.
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Category
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Rehabilitation
4
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Description
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Control group: Individuals will only receive resistance training. Resistance exercises: includes exercises for the muscles of the trunk area, which is divided into 3 stages, each stage is gradually more difficult. All patients will begin with Phase 1 exercises. Training will be done three days a week and in eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week.
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Category
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Rehabilitation
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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No
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Title of funding source
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Kharazmi University
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is 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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Only data related to demographic and outcomes information is shared.
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When the data will become available and for how long
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After publishing the article/articles extracted from the study
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To whom data/document is available
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Data upon reasonable request of the Clinical Trial Registry
Iran, journals and people/university researchers who are in this field
Research and scientific activities can be displayed and shared
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Under which criteria data/document could be used
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Data analysis and use of documents can only be done provided that their results are reported in scientific articles conducted by researchers and academic researchers. Necessary conditions for sending data and documents include 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation of how to use the data or documents.
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From where data/document is obtainable
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Through requesting from Amir Letafatkar
letafatkaramir@yahoo.com
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What processes are involved for a request to access data/document
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The applicant can request details from the researchers within 7 to 14 days using the message sent by email.
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Comments
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