Evaluation of the effect of lumbopelvic fascial release alone with lumbopelvic and cervical fascial release on pain intensity, functional disability, pressure pain threshold, quality of life and sonoelastography indices of the fascia in both regions in non-specific chronic low back pain patients associated with neck pain
Due to the connection of the fascias of different parts of the spine, in this study it is possible to examine the effect of releasing the fascia in one area on areas far away from applying the technique.
Design
The present study is a randomized clinical trial with two parallel groups.
The sample size was based on similar studies, using G-power software and considering the average pain index with 95% confidence and 80% power.
Patients will be assigned to two groups based on the random block method (block size of 4 and allocation ratio 1:1) using the website www.randomization.com.
Settings and conduct
In Tehran's private physiotherapy clinic, after completing the informed consent form and background information and measuring primary and secondary outcomes, patients will receive treatment for two consecutive weeks and will be followed up for two weeks. The outcome assessor and the person performing the analysis will be blinded.
Participants/Inclusion and exclusion criteria
People with the simultaneous complication of non-specific chronic back pain and neck pain, where the severity of back pain is greater compared to the neck
Age between 20 and 55 years
Not having back pain and neck pain caused by specific pathologies
Not being pregnant
Not receiving painkillers and anti-inflammatory drugs during the last 3 to 7 days
Not currently receiving physical therapy or other treatment
Attending therapy sessions regularly
Willingness to continue participating in the study
Absence of contracting or developing cases (after the start of the study) that for any reason violates the criteria for entering the study
Intervention groups
Group A: they receive lumbopelvic fascial release.
Group B: they receive lumbopelvic and cervical fascial release.
Main outcome variables
Primary outcomes are pain and disability, and secondary outcomes are pressure pain threshold, quality of life, and fascial elasticity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230502058059N1
Registration date:2023-07-09, 1402/04/18
Registration timing:prospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Soodeh Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6911
Email address
soodeh.zandi@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-15, 1402/04/24
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lumbopelvic fascial release alone with lumbopelvic and cervical fascial release on pain intensity, functional disability, pressure pain threshold, quality of life and sonoelastography indices of the fascia in both regions in non-specific chronic low back pain patients associated with neck pain
Public title
Evaluation of the effect of lumbopelvic fascial release alone with lumbopelvic and cervical fascial release on pain intensity, functional disability, pressure pain threshold, quality of life and sonoelastography indices of the fascia in both regions in non-specific chronic low back pain patients associated with neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with the simultaneous complication of non-specific chronic low back pain and neck pain, where the intensity of low back pain is greater compared to the neck pain
Age between 20 and 55 years
Not having low back pain and neck pain caused by specific pathologies
Not receiving painkillers and anti-inflammatory drugs in the last 3-7 days
Not currently receiving physical therapy or other treatment
Exclusion criteria:
pregnancy
Not attending regular therapy sessions
Unwillingness to continue participating in the study
Infecting or developing cases (after the start of the study) that violates the criteria for entering the study for any reason
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be assigned to two groups based on the random block method (block size of 4 and allocation ratio 1:1) using the website www.randomization.com.
To conceal the sequence of random allocation, numbered sealed envelopes containing group A or group B contents will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the outcome evaluator and the person who analyzes the results will be blind to the study conditions. In this way, the questionnaires are taken by another person and the sonoelastography is performed by a radiologist and the results are analyzed by a statistician. In this study, the patients are blinded in terms of placement in the groups, but they are not blinded in terms of the type and place of treatment they receive, because the treatment process is explained to the patient. Also, the therapist is not blind and a trained and skilled physiotherapist (myself) performs fascia release.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences
Street address
First bell, No. 42, Dolatshad West St., Farid Afshar St., Zafar St
City
Tehran
Province
Tehran
Postal code
1916615463
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.USWR.REC.1401.250
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M95.9-M99.
ICD-10 code description
XIII Diseases of the musculoskeletal system and connective tissue
2
Description of health condition studied
Neck pain
ICD-10 code
M95.9-M99.
ICD-10 code description
XIII Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Pain score on Visual Analog Scale
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Visual Analog Scale
2
Description
Back disability score in back disability questionnaire
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Oswestry Disability Index
3
Description
Neck disability score in neck disability questionnaire
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Neck Disability Index
Secondary outcomes
1
Description
Pressure pain threshold score
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Algometer tool
2
Description
Quality of life score
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Short form health survay
3
Description
Fascia elasticity
Timepoint
Before the start of the intervention, at the end of the intervention and after the two-week follow-up
Method of measurement
Sonoelastography
Intervention groups
1
Description
The first intervention group: they receive lumbo-pelvic fascial release.
Category
Rehabilitation
2
Description
The second intervention group: they receive lumbo-pelvic and cervical fascial release.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Rehabilitation Center of Medico Plus Center Complex
Full name of responsible person
Soodeh Zandi
Street address
unit 502, 5th floor, Medico Plus Center complex, Bakhshgandan Alley, not far from Tavanir, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1516743411
Phone
+98 21 8867 3288
Email
soodeh.zandi@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Vice President of Research and Technology University of Welfare and Rehabilitation Sciences
Street address
University of Welfare and Rehabilitation Sciences, Chibiyar St., Student Blvd., Valenjek St.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2895
Email
soodeh.zandi@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Soodeh Zandi
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 42, The First Bell., West Dolatshad Ave., Farid Afshar., Zafar
City
Tehran
Province
Tehran
Postal code
1916615463
Phone
+98 21 2200 6911
Fax
Email
soodeh.zandi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Soodeh Zandi
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 42, The First Bell., West Dolatshad Ave., Farid Afshar., Zafar
City
Tehran
Province
Tehran
Postal code
1916615463
Phone
+98 21 2200 6911
Fax
Email
soodeh.zandi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
soodeh zandi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 42, The First Bell., West Dolatshad Ave., Farid Afshar., Zafar
City
Tehran
Province
Tehran
Postal code
1916615463
Phone
+98 21 2200 6911
Email
soodeh.zandi@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Considering that in the ethical considerations section, we said that we do not publish the information, the data of the participants will not be published and there is no more information regarding the non-identification of individual data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available