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Comparative Effects of Post Isometric Relaxation Technique and Mulligan Traction Straight Leg Raise Technique Along with Retro walking on Hamstring Flexibility in Knee Osteoarthritis

Protocol summary

Study aim
The objective of this study is to check comparative effects of post isometric relaxation technique and mulligan traction straight leg raise technique along with retro walking on pain, hamstrings flexibility, quadriceps strength in knee osteoarthritis pain. To check effects of hamstrings flexibility and quadriceps strength on knee range of motion and functional activity in knee osteoarthritic patients
Design
Parallel group, Randomised trial
Settings and conduct
Settings: Madina Teaching Hospital FSD, Physio Fixx Physiotherapy center Faisal Hospital, FSD, Revive Healthcare Clinic, FSD, Sarfraz Healthcare Clinic, FSD, InMotion Physiotherapy and Rehabilitation Clinic, FSD Participant, Care provider, investigator and outcome assessor will be blinded .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Knee pain with crepitus sound, Radiographically finding Grade II-III, Both genders having age 40-60, Morning stiffness <30 minutes, tight Hamstrings muscles, NPRS score of 5 or greater than 5 Exclusion criteria: Any history of trauma to the knee ligament, pathology, recent surgery or any neurological impairment, severe valgus or varus deformity, active infection or inflammation, unwilling participants
Intervention groups
Baseline treatment: moist heat on hamstrings muscles, quadriceps isometrics by foam roller before treatment and retro walking at maximum pace for 5 minutes after treatment will be given to both groups A and B. Group A (Post isometric relaxation technique) will be treated with baseline treatment and PIR Technique. Repetition 3 to 4 times per day; three sessions per week on alternative days. Group B (Mulligan Traction Straight Leg raise technique) will be treated with baseline treatment and TSLR technique. Repetition 3 to 4 times per day, three sessions per week on alternative days.
Main outcome variables
Pain, Knee Range of Motion, Functional Activity and Cadence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230606058395N1
Registration date: 2023-06-26, 1402/04/05
Registration timing: registered_while_recruiting

Last update: 2023-06-26, 1402/04/05
Update count: 0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
TAHREEM MUNIR
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2693355
Email address
dr.tahreemnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-09, 1402/03/19
Expected recruitment end date
2023-07-09, 1402/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Post Isometric Relaxation Technique and Mulligan Traction Straight Leg Raise Technique Along with Retro walking on Hamstring Flexibility in Knee Osteoarthritis
Public title
Comparative Effects of PIR Technique and Mulligan TSLR Technique alng with Retrowalking in Knee OA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee pain with crepitus sound for 6 months or more Both genders having age 40-60 Morning stiffness lasting <30 minutes Bony tenderness with no palpable warmth Tight Hamstrings muscles Numeric Pain Rate Scale (NPRS) score of 5 or greater than 5 Radiographic finding Grade II-III according to Kellgren Lawrence Scale Bilateral or Unilateral Involvement
Exclusion criteria:
Any history of trauma to the knee ligament or any neurological impairment Any other pathology (e.g. fractures, bursitis, backache, radiating pain to the leg) History of recent steroid injection since 3 months Severe valgus or varus deformity History of recent lower limb or spinal surgeries Signs of active infection or inflammation to the knee joint Participants who are unwilling to participate in study
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by double lottery method while allocating individuals in Group A and Group B equally divide.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double Blinding As participant do not know about treatment or in which treatment Group, he/she was allocated. The care provider also do not know the individual group. Investigator and outcome assessor will only collect outcome of the individuals instead of knowing the group and treatment allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The University of Faisalabad
Street address
Street 5, Madan pura Faisalabad
City
Faisalabad
Postal code
38900
Approval date
2023-05-25, 1402/03/04
Ethics committee reference number
TUF/AddiREg/SB/360

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knee Pain
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Numeric Pain Rate Scale

2

Description
Range of motion
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Universal Goniometer

Secondary outcomes

1

Description
Functional Ability
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
WOMAC Questionnare

2

Description
Cadence
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Pedometer

Intervention groups

1

Description
Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold, then Group A was treated by (Post isometric relaxation technique). In Group A, the participants received a treatment known as the baseline treatment and Post-Isometric Relaxation (PIR) Technique. Patient Positioning: During this technique, the patient was positioned in a supine lying position, and the therapist stood on the side affected by the condition. Procedure: The involved leg's knee was gently extended, while the involved leg’s hip was flexed. Then therapist placed the patient's calf on their shoulder and positioned their hands across the upper leg, just above the knee joint. Next, the therapist passively flexed the hip of the affected leg until they encountered resistance. Isometric contraction: The patient was instructed to gently push down on the therapist's shoulder with their leg, exerting resistance against the therapist's effort to extend the hip while inhaling air by normal breathing. This created an isometric contraction, which was held for approximately 5-8 seconds, with appropriate breathing instructions provided to the patient. After the contraction, the patient was instructed to relax and do exhalation, then therapist gently flexed the whole leg at hip joint until the next point of resistance was reached. Repetition: This cycle was repeated 3 to 4 times per day, with three sessions per week on alternate days. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes.
Category
Rehabilitation

2

Description
Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold, then Group B will be treated with baseline treatment and TSLR technique involves sustained traction applied to the limb. Patient actively does the SLR and both the therapist and the patient note the range. Therapist now grasp patient lower leg proximal to the ankle joint and raise it off the bed to a position just short of the painful range. Therapist flexes his knees and holds the clasped leg to his chest. When the therapist extends his knees this will effectively apply a longitudinal traction to the leg provided the bed is low enough and the therapist is tall enough. Sustain this traction and undertake a straight leg raise as far as it will go provided there is no pain. Then pain free SLR with traction is given for 3 times, three sessions per week. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Revive Healthcare Center Faisalabad
Full name of responsible person
Rabia Khan
Street address
Abdullah colony samundri rad faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 302 9129919
Email
rabisandhu4549@gmail.com

2

Recruitment center
Name of recruitment center
Sarfraz Healthcare Clinic
Full name of responsible person
Sarfraz Ahmad
Street address
ST4 Sialvi Colony Faisalabad
City
Faisalabad
Postal code
38800
Phone
+92 306 9263828
Email
waliihaider02@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Falak naz
Street address
Sargodha Road Faisalabad
City
Faisalabad
Postal code
38200
Phone
+92 315 5020830
Email
cutenaz12345@gmail.com
Grant name
Rubina
Grant code / Reference number
009201
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rubina Zulfiqar
Position
Professsor and Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road near Kia motors Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9392994
Email
rubinazulfqar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Nimra Iftikhar
Position
Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 42 Daewoo road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38002
Phone
+92 41 2698888
Email
nimraiftikhar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Tahreem Munir
Position
Clinical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
P.454 Madan pura Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38900
Phone
+92 41 2693355
Email
hareemnaz658@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
Yes - There is 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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
for primary and secondary outcome
When the data will become available and for how long
4 months after publication, starting in the January 2024
To whom data/document is available
Working people in academic institutions
Under which criteria data/document could be used
Articlle
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Emails
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