Effects of adding Cognitive-Behavioral Therapy (CBT) to stability exercises on Lumbo-Pelvic Rhythm during lifting in non-specific low back pain patients with high fear of movement
Evaluation of the effect of adding cognitive-behavioral therapy to stability exercises on lumbar-pelvic rhythm in nonspecific low back pain patients with high fear of movement during lifting.
Design
A randomized clinical trial study with three parallel groups including two intervention groups and a control group, not blinded on 51 patients. Randomization is done using the 3 and 6 permutation random block method.
Settings and conduct
This study is performed with the voluntary participation of patients with nonspecific low back pain after fulfilling the conditions for entry and exit from the study in the neuromuscular rehabilitation research center of Semnan University of Medical Sciences. Initially, the lumbo-pelvic rhythm of all patients will be evaluated and the first and second groups will be given 2 days a week of stabilization exercises and the second group will also be given 1 day a week of cognitive-behavioral therapy and the control group will be without treatment. Patients' pelvic lumbar rhythm will be measured after 8 weeks of treatment and also one month after the end of the study. In this study, researcher is blind.
Participants/Inclusion and exclusion criteria
Patients with nonspecific low back pain who are between 20 and 55 years old and have periodic low back pain for at least 12 weeks. Patients' pain on the study day should be less than 3 based on the VAS scale and Fear of movement score on the Tampa scale is greater than 40. Participants had no signs of specific pathology in the spine.
Intervention groups
The first and second groups are taught stability exercises, the second group is given cognitive-behavioral therapy too, and the control group is without treatment and will receive several sessions of treatment after completing the study in order to observe ethical considerations.
Main outcome variables
Lumbo-pelvic rhythm, fear of movement, disability, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210101049910N1
Registration date:2021-03-12, 1399/12/22
Registration timing:prospective
Last update:2021-03-12, 1399/12/22
Update count:0
Registration date
2021-03-12, 1399/12/22
Registrant information
Name
Mahdie Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
mahdieghs21@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-09-05, 1400/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adding Cognitive-Behavioral Therapy (CBT) to stability exercises on Lumbo-Pelvic Rhythm during lifting in non-specific low back pain patients with high fear of movement
Public title
Effects of adding Cognitive-Behavioral Therapy (CBT) to stability exercises in low back pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-specific low back pain patients with high fear of movement
At least 12 weeks have passed since the low back pain
Having fear scores greater than 40 on the Tampa scale for kinesiophobia
According to VAS on the day of the study the maximum pain intensity of each patient must be 3
Exclusion criteria:
Any signs of serious spinal involvement
Having symptoms of cauda equina syndrome
Having symptoms of sciatica
Symptoms of spinal canal stenosis
Symptoms of nerve root involvement
History of spinal surgery
Spinal fracture
Structural abnormalities in the spine
Swelling, inflammation and dryness of the lumbar joints
Having a BMI of more than 25 kg per square meter
Report of uncorrected visual impairment
Severe cognitive and memory impairment
Pregnancy
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks of 3 and 6 are used for randomization. The intervention groups are called A and B; the control group is called C. Different 3 blocks including A, B, C, and 6 different blocks with two A, B, C are defined in different permutations. We will have 3 blocks of 3 and 7 blocks of 6. Each block is assigned a number from 0 to 9. Using a random number generator, the blocks are selected from 10 designated blocks, respectively. Eligible individuals are assigned to one of three groups A, B, or C in each block (from left to right) in a predetermined order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.SEMUMS.REC.1399.274
Health conditions studied
1
Description of health condition studied
Non-specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Lumbo-pelvic rhythm
Timepoint
The first session, last session, and one month after the end of the sessions
Method of measurement
3D motion analysis system
Secondary outcomes
1
Description
Fear of movement
Timepoint
The first session, last session and one month after the end of the sessions for the intervention and control groups
Method of measurement
Tampa scale for kinesiophobia
2
Description
Disability
Timepoint
The first session, last session and one month after the end of the sessions for the intervention and control groups
Method of measurement
Roland Morris disability questionnaire
3
Description
pain
Timepoint
The first session, last session and one month after the end of the sessions for the intervention and control groups
Method of measurement
Visual analog scale
Intervention groups
1
Description
First intervention group: Participants in this group will receive stabilization exercises that involve pulling the abdomen in 10 different positions for eight weeks, two days in a week. Patients will be taught how to do the exercises orally and using pictures. The abdominal inhalation practice is held for 10 seconds and is repeated 10 times with a pause of 3 seconds and the time interval of each Practice until the next exercise is 60 seconds. The exercises are progressive and the number of exercises increases over time.
Category
Rehabilitation
2
Description
Second intervention group: In addition to trunk stabilization exercises that will be given to the subjects for eight weeks and two sessions per week, cognitive behavioral therapy will also be given to the participants of this group. This treatment is based on problem solving, so in the first stage, the patient is evaluated by the therapist. Evaluation in this treatment aims to collect information that based on the cognitive model, determine how the disorder is formed and its continuation. The psychotherapist examines the patient's mood and asks him or her to make a list of his or her problems, write down his or her thoughts, identify abnormal behaviors, and try to control them. Each week, a treatment session is provided for patients in this group, the first session will be 2 hours and the next sessions will be 30 minutes for 8 weeks. Except for the first session, which is more about introducing the patient to the treatment process, in the next sessions, the therapist and the patient review the previous week and both work together to determine the current agenda. In the treatment sessions, the treatment assignments are reviewed, the current agenda is executed, a new assignment is determined, and at the end of each session, the patient is asked to comment on the session.
Category
Rehabilitation
3
Description
Control group: This group will not receive treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Mahdie Ghasemian
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mahdieghs21@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Faculty member of the Faculty of Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
rosehed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Faculty member of the Faculty of the Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
rosehed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Faculty member of the Faculty of Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
rosehed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available