Protocol summary

Study aim
The Effectiveness of Gluteus Maximus Activation and Kinesio Taping along with Muscle Energy Technique on Pain, Alignment and Functional Activities in Subject with Anterior Innominate Rotation Dysfunction
Design
Forty-five patients with anterior innominate rotation were divided into three groups (gluteus maximus exercises, kinesio tape and control) in a simple random manner using a sealed envelope. The study is single blinded with parallel groups.
Settings and conduct
This single blinded study (data analyst) will be conducted in the physiotherapy clinic of the rehabilitation faculty of Tehran University of Medical Sciences, and the participants will be randomly divided into three groups (two intervention groups and a control group) and will be evaluated before and after the intervention (after six sessions).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-50 years old, chronic sacroiliac joint dysfunction as diagnosed by at least three positive tests out of the five specific orthopedic sacroiliac provocation tests. Participants who are taking analgesic medication (e.g., Ibuprofen, Paracetamol) will be included following a three day wash out period. Exclusion criteria: Absolute contraindications to spinal manipulative therapy (i.e., abdominal aortic aneurysm, disc prolapse, fractures, osteoporosis, dislocation, bone tumors and bone infections and/or kinesio taping (malignancy, cellulitis, skin infections and open wounds, and deep vein thrombosis). Low back pain due to a history of trauma and radiculopathy.
Intervention groups
Both intervention groups will receive muscle energy techniques. One of the intervention groups receives gluteus maximus exercises and the other receives kinesio tape. The control group will only receive muscle energy techniques.
Main outcome variables
Pain, Alignment, Functional impairment, Balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210214050356N6
Registration date: 2022-08-15, 1401/05/24
Registration timing: prospective

Last update: 2022-08-15, 1401/05/24
Update count: 0
Registration date
2022-08-15, 1401/05/24
Registrant information
Name
Sara Fereydounnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
s-fereydounnia@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Gluteus Maximus Activation and Kinesio Taping along with Muscle Energy Technique on Pain, Alignment and Functional Activities in Subject with Anterior Innominate Rotation Dysfunction
Public title
Taping and Muscle Contraction in Pelvic Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-50 years old Chronic sacroiliac joint dysfunction as diagnosed by at least three positive tests out of the five specific orthopedic sacroiliac provocation tests. Participants who are taking analgesic medication (e.g., Ibuprofen, Paracetamol) will be included following a three day wash out period.
Exclusion criteria:
Absolute contraindications to spinal manipulative therapy (i.e., abdominal aortic aneurysm, disc prolapse, fractures, osteoporosis, dislocation, bone tumors and bone infections and/or kinesio taping (malignancy, cellulitis, skin infections and open wounds, and deep vein thrombosis). Low back pain due to a history of trauma and radiculopathy.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial evaluation, the patients are randomly placed in one of the three intervention 1, intervention 2 and control groups (randomization method: block of six, unit: cluster). The randomization process will be done by an independent person and each of the numbers assigned to the participants through the software (randomization tool: Random Allocation software with a block of six and equal allocation ratio for three groups), they are placed inside a sealed envelope and the patients receive this envelope from the clinic secretary who is not aware of the evaluation processes and etc.
Blinding (investigator's opinion)
Single blinded
Blinding description
As mentioned above, the study will be single-blinded. In this way, the participants know in which group they are, also the therapist, who is the person who performs the intervention and evaluates the outcome measures, knows in which group the participants are. But the person responsible for analyzing the data is unaware of which of the study groups the data belongs to.
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 of
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.TUMS.FNM.REC.1401.060

Health conditions studied

1

Description of health condition studied
Dislocation of other and unspecified parts of lumbar spine and pelvis (anterior innominate rotation)
ICD-10 code
S33.3
ICD-10 code description
Dislocation of other and unspecified parts of lumbar spine and pelvis

Primary outcomes

1

Description
Pain at rest
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Visual Analogue Scale

2

Description
Pain during motion
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Visual Analogue Scale

3

Description
Alignment
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Photogrammetric pelvic tilt angles analysis

4

Description
Functional impairment
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Oswestry disability index

5

Description
Balance
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Y-Balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Group 1 (n = 15) will receive Gluteus Maximus strengthening exercises with muscle energy techniques for inducing posterior rotation of ilium, three sessions in a week for two weeks.
Category
Rehabilitation

2

Description
Intervention group 2: Group 2 (n = 15) will receive Kinesio Taping for facilitation of rectus abominis and external oblique muscles and mechanical correction for maintaining the position of ilium with muscle energy techniques for inducing posterior rotation of ilium, three sessions in a week for two weeks.
Category
Rehabilitation

3

Description
Control group: Group 3 (n = 15) will receive muscle energy techniques for inducing posterior rotation of ilium, three sessions in a week for two weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia
Street address
corner of Ghods Street, Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 7752 8468
Email
s-fereydounnia@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 8163 3639
Email
research@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
Sara Fereydounnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
Email
S-fereydounnia@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
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
Sara Fereydounnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
Email
S-fereydounnia@sina.tums.ac.ir

Sharing plan

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 3 months after the articles are published
To whom data/document is available
For researchers working in academic, scientific and hospital institutions
Under which criteria data/document could be used
Researchers working in the field of musculoskeletal physiotherapy and manual therapy.
From where data/document is obtainable
Applicants for documentation can contact Dr. Sara Fereydounnia via email. S-fereydounnia@sina.tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month.
Comments
Loading...