The effectiveness of muscle energy techniques on clinical signs in individuals with trigger points related to chronic non-specific back pain (a double-blind clinical trial)
to investigate The effectiveness of muscle energy techniques on clinical signs in individuals with trigger points related to chronic non-specific back pain
Design
The present study will be a randomized, double-blind, controlled trial.
Settings and conduct
After selecting people with non-specific chronic back pain using non-probability sampling method, the patients will be randomly divided into two groups of muscle energy techniques (first group) and placebo group of muscle energy techniques (second group). In both treatment groups, participants will undergo routine physical therapy (includes low-power laser and fixed exercises). Both groups will be treated for 9 sessions in 3 days. Also, this study is a double-blind study in which the participants, the one who evaluates the outcomes and the one who analyzes the characteristics of the patients will be treated in two groups. This study will be conducted in the Faculty of Rehabilitation Sciences of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Patients aged between 20 to 50 years
no referral pain to lower extremities
Moderate pain intensity (between 3 to 6) based on Numerical Pain Rating Scale.
no specific cause for a subject's chronic back pain.
Patients with trigger points in the quadratus lumborum and erector spine muscles and gluteus medius muscle
Intervention groups
The treatments of the intervention group include muscle energy techniques and routine physiotherapy. The treatment of the control group includes sham muscle energy techniques along with routine physiotherapy.
Main outcome variables
A)Pain intensity measurement based on Numerical Pain Rating Scale B) Function based on Oswestry Disability Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045652N6
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:1
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
marzieh Yassin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
m.yassin.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of muscle energy techniques on clinical signs in individuals with trigger points related to chronic non-specific back pain (a double-blind clinical trial)
Public title
The effectiveness of a type of manual therapy on clinical sign in individuals with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 20 to 50 years
No referral pain to lower extremities
Moderate pain intensity (between 3 to 6) based on Numerical Pain Rating Scale
Patients with trigger points in the quadratus lumborum and erector spine muscles and gluteus medius muscle
Exclusion criteria:
History of lumbar surgery
Complications that affect the treatment process such as systemic diseases, neurological disorders, inflammatory conditions, infectious conditions, structural and degenerative changes, metabolic bone diseases and bleeding disorder.
Fracture
People who have received exercise therapy or manual treatments or dry needling for the lumbar region in past month.
Active cancer
Pregnancy
Long history of steroid use
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible chronic non-specific low back pain patients will be randomized to an intervention group ( muscle energy techniques and routine physical therapy) and a control group (sham muscle energy techniques and routine physical therapy) with a ratio of 1:1. Randomized allocation will be performed by using permuted block randomization method, which consists of four-letter blocks made of letters A and B. Then, the random treatment list that will be obtained at the end of the random allocation task will be placed in letters A and B inside the sealed and numbered envelopes (muscle energy techniques and letter B indicates sham muscle energy techniques). The random assignment process will be performed by someone outside the research team before the study begins. After the initial evaluation of the patient by the examiner, the numbered envelopes will be presented to him/her according to the ordinal number of each person admitted to the study. Finally, after each patient enters the treatment sessions, the therapist will adjust the treatment interventions based on the letters in the envelope. Patients are asked not to provide their grouping information to the assessor to prevent data contamination.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, outcome assessor and data analyzer will be kept blind to being assigned to the study groups.
Blinding method:
A) Participants: Participants will not have information about which treatment group they have entered, and also in each treatment group, people will receive a real treatment in addition to sham of the real treatment in the other group (the first group includes muscle energy techniques and the second group includes sham muscle energy techniques ) were used so the participants could not guess which treatment group they have entered.
B) Outcome assessor: Outcome assessment will be performed by a person who does not know the grouping of the individuals and the treatments performed in each treatment group.
C) Data analyzer: Data analysis will be performed by a person who does not know the grouping of individuals and the treatments performed in each treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ایران
Street address
Dormitory of the school of Rehabilitation of Iran University of Medical Sciences, Shah nazari Ave., Madar square, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.IUMS.REC.1401.189
Health conditions studied
1
Description of health condition studied
chronic nonspecific low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain
Primary outcomes
1
Description
Pain intensity based on Numerical Pain Rating Scale
Timepoint
Pain intensity measurement before intervention and after intervention
Method of measurement
numerical pain rating scale
2
Description
Functional disability based on Oswestry Disability Index
Timepoint
Functional disability measurement before intervention and after intervention
Method of measurement
Oswestry Disability Index
Secondary outcomes
1
Description
Range of motion
Timepoint
Before intervention and after intervention
Method of measurement
goniameter
2
Description
Pain pressure threshold
Timepoint
before and after intervention
Method of measurement
algometer
Intervention groups
1
Description
Intervention group:The treatments of this group include muscle energy techniques and routine physiotherapy: a) Muscle energy techniques: This technique is performed for the quadratus lumborum, erector spinae and gluteus medius muscles. To perform this technique after being in the treatment position The patient is asked to contract the muscle with a low power and a maximum of 20-35% of his power. After 5 to 7 seconds, the patient is asked to relax completely, then the therapist takes the muscle to a stretched position and maintains the stretched position for 30 seconds. After 2 to 3 seconds of rest, the above steps will be repeated 3 times.b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks
Category
Rehabilitation
2
Description
Control group:The treatments of this group include sham muscle energy techniques and routine physiotherapy: a) Sham muscle energy techniques are performed for the quadratus lumborum, erector spinae and gluteus medius muscles. In this way, the muscle is brought to the position of performing the technique, but no technique is performed.The treatment time will be the same in both groups. b)Routine physiotherapy includes a low-power diode laser (LAS-Expert, physiomed, made in Germany - with 14 diodes), wavelength 785 nm, output power 700 mW, with a frequency of 50 to 60 Hz, 50 J/cm2, as a pulse frequency With 80% duty cycle = 1.5 to 2 cm outside the spines of the lumbar vertebrae, it will be used for approximately 20 minutes.Core stability exercises will consist of three stages of exercises, The first week will include the exercises of the first stage, the second weeks include the first and second stage exercises, and the third week will include all of the exercises. The first stage exercises will include: abdominal drawing, abdominal bracing lift and alternative arm and leg lift, the second stage exercises will include: unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up, sit back and the third stage exercises will include: bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will be repeated 10 times and each repetition will last 10 seconds and there will be one minute break between each exercise. This group will be treated for 9 sessions over 3 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation school of Iran university of medical science
Full name of responsible person
Marzieh yassin
Street address
خیابان میرداماد، میدان مادر، خیابان شاه نظری، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
rehab@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Iran University of Medical Sciences, Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 5503
Email
Research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?