Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ERGON Technique
Proprioceptive Neuromuscular Facilitation (PNF) stretching
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Ergon Technique, Proprioceptive Neuromuscular Facilitation stretching, Active Knee Extension Test, Western Ontario and McMaster Universities Arthritis Index, Visual Analogue Scale
Eligibility Criteria
Inclusion Criteria:
- Unilateral/bilateral osteoarthritis
- Participants with unilateral/bilateral hamstring tightness
- 200 from Active Knee Extension test
- Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis
Exclusion Criteria:
- Participant failing to fall in the category below will be excluded from the study:
- Any lower extremity injury in past 3 months
- Any fracture or surgery done for pelvis, hip or knee.
- Any neurological symptoms.
- Any recent knee reconstructive surgery
- Burns of lower extremities
- Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness
Sites / Locations
- RHS Rehabilitation Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ERGON Technique Group
Proprioceptive Neuromuscular Facilitation(PNF) stretching Group
Arm Description
Patients in this group will receive ERGON Technique along with conventional therapy
Patients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.
Western Ontario and McMaster Universities Arthritis Index(WOMAC)
The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
Active Knee Extension Test
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.
Secondary Outcome Measures
Full Information
NCT ID
NCT05110326
First Posted
October 26, 2021
Last Updated
March 15, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05110326
Brief Title
Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis
Official Title
Comparison of Ergon Technique Versus Proprioceptive Neuromuscular Facilitation Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, Ergon Technique, Proprioceptive Neuromuscular Facilitation stretching, Active Knee Extension Test, Western Ontario and McMaster Universities Arthritis Index, Visual Analogue Scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERGON Technique Group
Arm Type
Experimental
Arm Description
Patients in this group will receive ERGON Technique along with conventional therapy
Arm Title
Proprioceptive Neuromuscular Facilitation(PNF) stretching Group
Arm Type
Experimental
Arm Description
Patients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy
Intervention Type
Other
Intervention Name(s)
ERGON Technique
Intervention Description
Hot pack for 15 minutes.
Patient position: Prone with knee flexion approximately 45◦.
Position of therapist: Standing at the affected side of patient.
Technique:Massage cream will be applied on the hamstring and overactive or short muscle fibres that are restricted.The instrument will be applied parallel to the muscle fibers, both in a distal to proximal and them proximal to distal direction as needed.Then gentle massage stroking from the origin to the insertion will be performed using the instrument. Instrument Assisted Soft Tissue Mobilization(IASTM) will be applied for 5 minutes.
Strengthening exercises for quadriceps and hamstring will then be performed.
Isometrics exercises of Quadriceps: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
Isometrics exercises Hamstrings: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
Wall sits: For 10 seconds, 5 sets.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation (PNF) stretching
Intervention Description
The patient will be laid down prone and moist heat will be given for 15 minutes prior to stretching the hamstrings.
Then patient will be lying supine with hip in 90⁰ of flexion. Patient's knee will be extended until a very mild stretching sensation is felt in hamstring muscles.
Then patient will be asked to flex the knee against the resistance applied by hand of therapist.
The patient will be asked to use a force of around 50% of maximal strength and an isometric form of contraction will be gained in the hamstring muscles. The patient will hold the contraction for 8 seconds and then the therapist command to relax the hamstring muscle.
Immediately after the muscle relaxation the therapist further stretches the hamstring muscles up to a point where the subject reported a mild to moderate stretching sensation without any pain and will be held for 30 seconds.
The procedure will be repeated 3 times in every session.
Strengthening Exercises:
Same as ERGON Group
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.
Time Frame
6 Weeks
Title
Western Ontario and McMaster Universities Arthritis Index(WOMAC)
Description
The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
Time Frame
6 Weeks
Title
Active Knee Extension Test
Description
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral/bilateral osteoarthritis
Participants with unilateral/bilateral hamstring tightness
200 from Active Knee Extension test
Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis
Exclusion Criteria:
Participant failing to fall in the category below will be excluded from the study:
Any lower extremity injury in past 3 months
Any fracture or surgery done for pelvis, hip or knee.
Any neurological symptoms.
Any recent knee reconstructive surgery
Burns of lower extremities
Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RHS Rehabilitation Centre
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis
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