Comparison between the effect of routine physiotherapy and routine physiotherapy with Psoas muscle direct myofascial release technique on pain and disability index in patient with chronic nonspecific low back pain
The aim of this study is to survey the effect of routine physiotherapy with Psoas muscle Myofascial release technique on pain and disability among patients with chronic nonspecific low back pain.
Design
Two arm parallel group randomized trial with control group, single blinded, phase 3 on 40 patients, random number table have been used for randomization
Settings and conduct
The subject of this study is the application of a kind of manual therapy that is being used in physiotherapy. The place of performing study is Isfahan Farhangian physiotherapy clinic. Intervention group receives routine physiotherapy and this manual technique (Psoas Myofascial release) and control group receives routine physiotherapy. The assessor is blinded and doesn't know what kind of treatment each participant has received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nonspecific chronic low back pain patient who have pain in lumbar for at least in past 3 months with tightness or stiffness of Psoas muscle. Non inclusion criteria: Serious spinal pathology and the conditions that result in non myofascial pain in lumbar region.
Intervention groups
Both intervention and control groups receive routine physiotherapy (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Intervention group will receive Psoas muscle Myofascial release technique in addition to routine physiotherapy. This technique is going to be done as following: In supine position with 90 degree hip and knees. Therapist puts her hands on Psoas muscle for 3 min and then will perform transvers sliding.
Main outcome variables
Pain score (on Visual Analog Scale); Disability index (Roland‐Morris disability questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049305N1
Registration date:2020-12-13, 1399/09/23
Registration timing:registered_while_recruiting
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Kosar Iranpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 2472
Email address
k.iranpour75@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of routine physiotherapy and routine physiotherapy with Psoas muscle direct myofascial release technique on pain and disability index in patient with chronic nonspecific low back pain
Public title
Effect of Psoas myofascial release in nonspecific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18_60 years old patient with diagnosed nonspecific chronic low back pain
Pain in lumbar region, at least since 3 months ago
Score 3_7 in Visual Analog Scale
Disability index score of 4_8 in Roland‐Morris disability questionnaire
Having enough literacy for filling the questionnaire
Having at least two parameters of tree following conditions:
- Positive modified Thomas test, at least in one side of pelvic
- Tenderness due to pressure on Psoas muscle, at least in one side of pelvic
- Producing pain and uncomfortable due to Psoas muscle maximum contraction, at least in one side of pelvic
Exclusion criteria:
Pregnancy
BMI score more than 30
History of lumbar spine surgery
Low back pain due to serious spinal pathology such as tumor, infection, inflammatory disorders
Symptoms of disc herniation (reduction of lower extremity force, reduction of reflexes of lower extremity, positive Straight Leg Raise test in less than 45 degrees.
No pain reduction in rest, No pain increasing with activity
History of fracture in spinal region
History of recent trauma to spine
Pain in resting
Joint disorders such as Rheumatoid Arthritis
Lumbar vertebral Spondylolisthesis
Using paregoric and muscle relaxant medicine in past 48 hours before assessment
Fibromyalgia
History of myofascial or rehabilitation treatment in past 2 months
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple randomization is used. For generating random sequence, table of random numbers generated by Start Trek website is used, there are 40 numbers in this table which are coding from 01 to 40. After writing the numbers by the researcher, she will read the randomized number from left to right, so the first 20 codes will be in the control group and the second 20 codes will be in the intervention group. Based on the time of attending, the participants will be coded from 01, 02, ..., 40 till the sample size being completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blinded study. The assessor (who going to assess the outcome measures and collect the data) will be blind. Each participant will be aware of treatment that is being used for her/him. The researcher(physiotherapist) is aware of each participant's sort of treatment.
The person who prepares the article draft and Data Safety and Monitoring Committee, will not be aware of each participant's grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.386
Health conditions studied
1
Description of health condition studied
Nonspecific chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain score
Timepoint
Before starting the treatment, 1day and 4 weeks after the end of treatment
Method of measurement
Visual Analog Scale
2
Description
Disability index
Timepoint
Before starting the treatment, 1day and 4 weeks after the end of treatment
Method of measurement
Roland‐Morris Disability Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is Psoas muscle myofascial release technique, This technique is going to be done as following: In supine position with 90 degree hip and knees. Therapist puts her hands on Psoas muscle for 3 min and then will perform transvers sliding. In the intervention group, in addition to this technique, routine physiotherapy is performed (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Patients will receive 8 sessions of routine physiotherapy in 3 weeks (3 sessions per week) and 4 sessions of myofascial release therapy (in sessions 1, 3, 5, 7).
Category
Rehabilitation
2
Description
Control group: Participants in the control group will receive routine physiotherapy in 8 sessions (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Farhangian physiotherapy clinic
Full name of responsible person
Kosar Iranpour
Street address
In front of the General Department of Education of Isfahan Province, Hasht Behesht Blvd, Baghe Goldaste Ave, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8145683111
Phone
+98 31 3222 6861
Email
k.iranpour75@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooye Javanmard
Street address
Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data obtained, including information on the main outcomes and individual characteristics of the participants (including height, weight, body mass index and gender) will be published as an article without identifying the participant. If needed, individual information will be shared with other researchers and the Data Safety and Monitoring Committee.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions can apply for information.
Under which criteria data/document could be used
Other researchers can be used to collect data or write systematic reviews, to guide and improve the quality of patients' treatment and encourage similar studies.
From where data/document is obtainable
Applicants should contact the general manager of this research to obtain documentation and data. For this purpose, contact Kosar Iranpour at 00989217104152, email address K.iranpour75@gmail.com and postal code 81799-37531. Address: No. 12, Lale Ally, Farabi2 Ave, Ghadir Blvd, Sepahanshahr Town, Isfahan.
What processes are involved for a request to access data/document
After 6 months from the publication of the results of the study, individuals who have a certificate from academic institutions can apply for data and documents and receive the documents about 1 to 2 months later.