Effects of diaphragmatic myofascial release on pain, balance and quality of life in patients with nonspecific chronic low back pain: A regional interdependence model
According to relative high prevalence of non specific chronic low back pain and the absence of conclusive treatment for this disorder, aim of this study is to provide an option in treatment of this disorder.
Design
ََA concealed, randomized with "Random allocation software", two parallel group trial with blinded participants and post intervention assessor.
Settings and conduct
The study would take place in a physiotherapy clinic; The first assessor is the therapist who would do intervention and sham intervention and the second assessor is another person who does not know about groups. Both group will receive analgesic treatment with electrical stimulations; Intervention group will receive diaphragm myofascial release and sham group will receive same hand placements by therapist but no release.
Participants/Inclusion and exclusion criteria
Participants of this study are patients with non specific chronic low back pain who do not receive concurrent treatment for their pain; Participants are aged between 18 - 40 years old. They lack history of surgery in thoracic and lumbar regions or infection and fracture in the region of treatment.
Intervention groups
In the intervention group which includes12 non specific low back pain patients the myofascial release of diaphragm will be done with two techniques. There will be three sessions of treatment and myofascial release of diaphragm will be done in every session. In the sham intervention group which includes12 non specific low back pain patients the same hand placements will take place but with no intention to release.
Effects of diaphragmatic myofascial release on pain, balance and quality of life in patients with nonspecific chronic low back pain: A regional interdependence model
Public title
Effect of diaphragm myofascial release on non specific chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of non specific chronic low back pain (Have symptoms more than 3 months)
Patients with consent
Pain in the area between last rib and gluteal crease
No radicular symptoms
No nerve root compression symptoms
No history of surgery in thoracic or lumbar regions
Exclusion criteria:
Pain below gluteal crease
Infection or fracture in the particular region
Neurologic disorders
Receiving treatment for low back pain concurrent with this study
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of participants will be done with "Random allocation software" with 4 randomized blocks and 1:1 allocation ratio.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be randomized in two intervention and sham groups. none of the participants know which group is he in so the participants would be blind to grouping. The intervention and sham intervention would get done by the same therapist that has assessed the baseline measurements; After the last session, another therapist would measure the outcomes without knowing which group each participant was in so the second assessor would be blind to the participants and grouping; Therefore it will be a two blinded RCT.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Tehran University of medical sciences
Street address
Room no. 604, 6th floor, Tehran university of medical sciences central building, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1769654649
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.TUMS.FNM.REC.1401.119
Health conditions studied
1
Description of health condition studied
Non specific chronic low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain is an unpleasant emotional and sensory experience related to an injury or a potential injury.
Timepoint
First and last session of treatment
Method of measurement
Using Visual analogue scale
Secondary outcomes
1
Description
Disability is a prolonged dysfunction of body, mind, sensation or a complex of them which prevents individuals to participate efficiently in society.
Timepoint
First session of treatment and one week after the last session of treatment.
Method of measurement
Roland Morris low back pain questionnaire
2
Description
Mobility of lumbopelvic region with flexion of trunk and pelvis.
Timepoint
First and last sessions of treatment
Method of measurement
Finger tip to floor distance test with measuring the distance between 3rd finger and the floor with the patient flexed fully from trunk and pelvis in standing position.
3
Description
Dynamic balance is the ability to maintain body line of gravity within base of support margins during extremities movements and weight shifting.
Timepoint
First and last sessions of treatment
Method of measurement
by measuring the maximal reaching by patient in standing position without lower extremity movement
4
Description
Static balance is the ability to maintain body line of gravity within base of support margins while standing still
Timepoint
First and last sessions of treatment
Method of measurement
By measuring the person's ability to maintain his/her balance during single leg stance.
5
Description
Chest expansion is the difference of thoracic level perimeter during maximal inhalation and exhalation.
Timepoint
First and last sessions of treatment
Method of measurement
By measuring the difference of thoracic level perimeter during maximal inhalation and exhalation.
Intervention groups
1
Description
Intervention group: In the intervention group which includes12 non specific low back pain patients the myofascial release of diaphragm will be done with two techniques. There will be three sessions of treatment and myofascial release of diaphragm will be done in every session.
Category
Rehabilitation
2
Description
Control group: In the sham intervention group which includes12 non specific low back pain patients the same hand placements will take place but with no intention to release.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Energy rehabilitation center
Full name of responsible person
Soheil hejazi yekta
Street address
No. 67, Bustan 7 alley, Pasdaran Exp, Tehran
City
Tehran
Province
Tehran
Postal code
1666714971
Phone
+98 21 2279 7268
Email
soheilhejaziyekta@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Street address
Piche shemiran, Enghelab Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soheil hejazi yekta
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.67, 7th bustan, Eslami st, Tehran
City
Tehran
Province
Tehran
Postal code
1666714971
Phone
+98 21 2279 7268
Email
soheilhejaziyekta@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheil hejazi yekta
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.67, 7th bustan, Eslami st, Tehran
City
Tehran
Province
Tehran
Postal code
1666714971
Phone
+98 21 2279 7268
Email
soheilhejaziyekta@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheil hejazi yekta
Position
Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.67, 7th bustan, Eslami st, Tehran
City
Tehran
Province
Tehran
Postal code
1666714971
Phone
+98 21 2279 7268
Email
soheilhejaziyekta@gmail.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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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