Investigating the Effectiveness of Adding Lumbopelvic Core Stability Exercises to Muscle Energy Technique on Pain, Performance and Neurocognitive Parameters in Patients with Sacroiliac Joint Dysfunction
Understanding the therapeutic effects of adding central stability exercises to the muscle energy technique on patients with sacroiliac joint disorders
Design
A controlled, parallel-group, single-blind, randomized clinical trial of 30 patients.
Settings and conduct
6 treatment sessions are performed in Amir A'lam Hospital
Patients are blinded to the intervention and control groups (single blinding).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 18-45 years
Having literacy (at least a diploma for neuro-cognitive variables)
Having a unilateral disorder of AIR and PIR
The direction of the disorder side and the painful side are the same
Pain below the fifth lumbar vertebra (L5) and around the PSIS
Chronic pain that has lasted for at least 3 months
Minimum pain intensity based on VAS should be 30
The minimum degree of disability based on ODI should be 30%
Body mass index between 18-28 kg/m2
The positivity of 3 out of 5 iliac crest height tests, the level of PSISs, the level of ASISs, Standing Flexion Test and Gillet's Test, the positivity of Long Sitting Test and the positivity of 3 out of 5 tests Distraction Test, Compression Test, Thigh thrust test, sacral thrust test and Gaenslen's test
The minimum intensity of the disturbance in performing the Active Straight Leg Raise movement should be 3
Exclusion criteria:
Radiculopathy
Fractures of the spine and lower limbs
Lumbosacral surgery
Spinal deformity and scoliosis
Anatomical leg length difference with a difference of more than 1 cm
pregnancy
Rheumatoid arthritis and ankylosing spondylitis
Malignancies
Infection
Cardiovascular disease and pacemakers
The subject's unwillingness to cooperate in the beginning or continuation of the sessions
Intervention groups
Intervention group: Core stability exercises along with muscle energy technique
Control group: Muscle energy technique
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240728062565N1
Registration date:2024-10-05, 1403/07/14
Registration timing:registered_while_recruiting
Last update:2024-10-05, 1403/07/14
Update count:0
Registration date
2024-10-05, 1403/07/14
Registrant information
Name
Majid Rajabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8881 0325
Email address
mrajabian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Adding Lumbopelvic Core Stability Exercises to Muscle Energy Technique on Pain, Performance and Neurocognitive Parameters in Patients with Sacroiliac Joint Dysfunction
Public title
Effects of Core stability exercise in sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-45 years
Having literacy (at least a diploma for neuro-cognitive variables)
Having a unilateral disorder of AIR and PIR
The direction of the disorder side and the painful side are the same
Pain below the fifth lumbar vertebra (L5) and around the PSIS
Chronic pain that has lasted for at least 3 months
Minimum pain intensity based on VAS should be 30
The minimum degree of disability based on ODI should be 30%
Body mass index between 18-28 kg/m2
The positivity of 3 out of 5 iliac crest height tests, the level of PSISs, the level of ASISs, Standing Flexion Test and Gillet's Test, the positivity of Long Sitting Test and the positivity of 3 out of 5 tests Distraction Test, Compression Test, Thigh thrust test, sacral thrust test and Gaenslen's test
The minimum intensity of the disturbance in performing the Active Straight Leg Raise movement should be 3
Exclusion criteria:
Radiculopathy
Fractures of the spine and lower limbs
Lumbosacral surgery
Spinal deformity and scoliosis
Anatomical leg length difference with a difference of more than 1 cm
pregnancy
Rheumatoid arthritis and ankylosing spondylitis
Malignancies
Infection
Cardiovascular disease and pacemakers
The subject's unwillingness to cooperate in the beginning or continuation of the sessions
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization and quadruple block creation with 1:1 ratio
Randomization will be done using randomization.com
For the purpose of allocation concealment, sealed and numbered envelopes will be used, which will be provided to the participant by the secretary
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are blinded to control or intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1581749811
Approval date
2024-07-17, 1403/04/27
Ethics committee reference number
IR.TUMS.FNM.REC.1403.053
Health conditions studied
1
Description of health condition studied
Sacroiliac joint dysfunction
ICD-10 code
S33.6
ICD-10 code description
Sprain of sacroiliac joint
Primary outcomes
1
Description
Pain: To measure the pain of patients, a 100 mm long ruler known as Visual Analogue Scale will be used, with the word "no pain" at one end and the word "maximum pain" at the other end. In this study, people who have pain of at least 30 will be included in the study.
Timepoint
Before the start of the intervention, immediately after the first intervention session, after the 6th intervention session and one month after the last intervention session
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Neuro-cognitive variables that include visual and auditory selective reaction time and complex visual and complex auditory choice and prediction skill at low and high speed, which are measured with the Speed Anticipation Reaction Time system.
Timepoint
Before the first intervention, immediately after the first internal session, after the 6th intervention session and one month after the last intervention session
Method of measurement
Speed Anticipation Reaction Time system
Intervention groups
1
Description
Intervention group: Lumbo-pelvic core stability exercises along with muscle energy technique
Category
Treatment - Other
2
Description
Control group: Muscle energy technique
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Dr. Mostafa Rahimi
Street address
Saadi Ave.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6672 7060
Fax
+98 21 6670 8103
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid dalvand
Street address
Enghelab Ave., Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
hdalvand@sina.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
Dr. Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran university of medical science- School of rehabilitation
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
Shadmehr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran university of medical science- School of rehabilitation
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7763 6041
Email
Shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Rajabian
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 179, Somayyeh Ave., Iranshahr
City
Tehran
Province
Tehran
Postal code
1581749811
Phone
+98 21 8881 0325
Email
Mrajabian19@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