Effect of Iliotibial band Myofascial release Combined with valgus Controlled exercises on pain, range of motion, balance and quality of life in patients with grade II knee osteoarthritis.
The objective and aim of this study are:
To find out the effectiveness of myofascial release technique with Valgus correction exercise on balance, quality of life, range of motion and pain in patients with grade II knee osteoarthritis.
Design
parallel group randomized clinical trial and Randomization will be achieved through computer generated random number table.
Settings and conduct
Allied Hospital. it will be assessor who will be blinded about the type of intervention. Treatment will be given by principal /investigator
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
age: 40-60 years
Both gender
Iliotibial band tightness
Knee osteoarthritis ACR (American college of Rheumatology)
Exclusion Criteria:
knee arthroplasty
bone tumor
Any other pathology
Osteomyelitis
Intervention groups
Group A: Intervention group. Myofascial release technique
The individuals in the Group A will be treated using hot pack on knee area, quadricep isometrics 10 *10 and myofascial release Technique for iliotibial band. Patients will be asked to perform knee flexion and extension for another 5 minutes.
Frequency: Two Times a Week for 6 weeks
Group B: valgus correction exercise (VCE)
Technique: The individuals in the Group B will be treated using hot pack on knee area, quadricep isometrics 10 *10 and myofascial release Technique. In addition to this patient will perform valgus correction exercise (VCE) for 10 minutes.
Valgus correction exercise (VCE)
• Squat in front of mirror (0°-60° of knee flexion, performed in front of mirror to ensure the knee does not exceed the midfoot)
• Hip lateral rotation
• Lateral walk with elastic resistance around forefoot
Frequency: Two Times a Week for 6 weeks
The outcome measures will be assessed at baseline, third and at 6 weeks of intervention.
Main outcome variables
Pain, knee Range of motion, balance and qaulity of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230216057434N3
Registration date:2023-03-14, 1401/12/23
Registration timing:registered_while_recruiting
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Zainab Sheraz
Name of organization / entity
Riphah International University, Faisalabad
Country
Pakistan
Phone
+92 301 7070941
Email address
zainab.48@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-08, 1401/12/17
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iliotibial band Myofascial release Combined with valgus Controlled exercises on pain, range of motion, balance and quality of life in patients with grade II knee osteoarthritis.
Public title
Effectiveness of two manual therapy technique in osteo arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: 40-60 years
Both gender
Iliotibial band tightness
Knee osteoarthritis diagnosed as per ACR (American college of Rheumatology) criteria
Exclusion criteria:
knee arthroplasty
bone tumor
Any other knee pathology
Osteomyelitis
limb length shortening
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done through a computer software "Random allocation". The total sample size was entered with requirement to be allocated in two groups. An automated randomization list was achieved with attrition rate included.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding was done on part of outcome assessor who was an experienced therapist. Patients were assessed by him at the end of treatment session. He was blinded about the type of intervention patient has received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International University Faisalabad
Street address
Riphah International University, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
RCRAHS/REC/08
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Assessment will be performed at 0 week (baseline) at 3rd week and at completion of 6 weeks treatment
Method of measurement
Visual Analogue scale
2
Description
Range of motion
Timepoint
Assessment will be performed at 0 week (baseline) at 3rd week and at completion of 6 weeks treatment
Method of measurement
Goniometer
Secondary outcomes
1
Description
Quality of life
Timepoint
Assessment will be performed at 0 week (baseline) at 3rd week and at completion of 6 weeks treatment
Method of measurement
KOOS (Knee injury osteoarthritis outcome score)
2
Description
Balance
Timepoint
Assessment will be performed at 0 week (baseline) at 3rd week and at completion of 6 weeks treatment
Method of measurement
Berg Balance Scale
Intervention groups
1
Description
Intervention group 1 (Iliotibial Band Myofascial Release)
Category
Treatment - Other
2
Description
Control group: (Iliotibial Band Myofascial Release + Valgus control exercise)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Dr Laiba Fatima
Street address
Jail Road, Adjacent Faisalabad Medical University, Near Sargodha Road, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 335 2536667
Email
laibafatima2535@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self funded
Full name of responsible person
Zainab Sheraz
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Real patient involved
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available