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Completed

NCT Number: NCT05052593

Compressive Myofascial Release in Knee Osteoarthritis

The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional physiotherapy clinic Bahria town phase 6. The sample size was 52 calculated through open-epi tool. The participants were divided into two interventional groups each having 26 participants. The study duration was six months. Sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. Only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. Tools used in this study are Q angle, numeric pain rating scale, goniometry and WOMAC questionnaire, Self structured Questionnaire. Data was collected at baseline, at the end of 3rd session and 6th session. Data analyzed through SPSS version 23.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bone and joints centre, Rawalpindi, Punjab Province, Pakistan

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About this study

knee osteoarthritis is commonly manifested as decreased joint space, sub chondral bone sclerosis, bony spur formation, cartilage loss and mainly lateral patellar tracking(2).Lateral patellar tracking is a condition in which patellar move laterally in relation to femoral groove on flexion and extension(4). Patellofemoral disorders are very common in patients of knee OA. One of the very common manifestation of which is lateral patellar tracking(5). Patella move laterally due to certain disorders of knee that include patellofemoral pain syndrome and anterior knee pain. Q-angle is used as an indicator of patellofemoral pain syndrome. When Q angle exceeds its normal limit i.e. 15-20 degrees it leads to lateral mal positioning of patella(6). Rozenfeld, E et al. in 2019 conducted a cross sectional study with a diagnosis of anterior knee pain that suggests highest prevalence of myofascial trigger points in distal vastus lateralis and mid and distal vastus lateralis. It also reported that presence of trigger points in anterior knee pain(7). There are several techniques that are used to release trigger points.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Includes diagnosed cases of knee osteoarthritis
  • Grades 2-3 according to the Kellgren and Lawrence method of grading(1)
  • Includes patients from the age group of 50 years and above(3)
  • Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test(4)

Exclusion criteria

  • history of recent trauma to knee
  • History of hip disease
  • Past history of knee surgery/arthroplasty
  • Intraarticular corticosteroid injection

Treatment and study plan

compressive myofascial release

Other

Patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. With pressure directed from distal to proximal.

conventional treatment group

Other

Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold)

Primary outcomes

  1. Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale:

    Time frame: 4th Week

    Western Ontario and McMaster Universities Arthrosis Index WOMAC was first developed in 1988 by Bellamy for use in patients with hip and knee osteoarthritis is a self-administered tool comprising of 24 items divided into 3 sub scales. It was used to assess pain, stiffness and physical function in knee osteoarthritis patients which were allocated in the study. Patient's pain is assessed by asking about intensity of pain in different positions including pain intensity at rest through 5 questions. Patient is asked about stiffness level in the morning and evening (2 questions). Patients is also assessed for difficulty doing several daily and self-care activities in 17 different questions. Each item in sub scale carries maximum score of 4 and minimum score of 0. Overall score of WOMAC scale is 100 with a cutoff value of 39. In first session, 2 and 4 weeks after treatment sessions.

Secondary outcomes

  1. Numeric Pain Rating Scale:

    Time frame: 4th Week

    Numeric pain rating scale is a type of scale which is used to measure pain intensity. It is easy to use as the patient can report the intensity of his/her pain by simply looking at the scale. The scale has ratings from 0 to 10, where the point 0 means no pain, the points 1, 2 and 3 measure pain of mild intensity, the points 4,5 and 6 measure pain of moderate intensity and the demarcations 7,8,9 and 10 measures severe intensity of pain. It was used in this study to measure the intensity of knee joint pain reported by each patient. Numeric pain rating scale is preferred over visual analog scale for use in elderly individuals. The patients are asked about the subjective examination of intensity of pain after describing the demarcations present on the scale to the patient about the maximum and minimum values. In first session, 2 and 4 weeks after treatment sessions.

Other outcomes

  1. Functional Reach Test:

    Time frame: 4th Week

    Functional reach test was utilized to determine instability present in the patient, in particular, dynamic standing balance was measured. During this test the participant was advised to stand next to the wall, not leaning against the wall, feet were at a comfortable distance apart. Care must be taken to assess the patient who is elderly and the one who has balance issues. Continuous supervision throughout the test is necessary and therapist must be there to help patient achieve and maintain the position. The participant was asked to flex the dominant arm to 90 degree and reach as much forward as possible without overbalancing. In first session, 2 and 4 weeks after treatment sessions.

  2. Measurement Quadriceps Angle:

    Time frame: 4th Week

    Q-angle measurement was used to assess lateral patellar tilting that is the primary objective. Q angle measurement with a goniometer is a standardized protocol and test-retest reliability was found out through intra-tester reliability study which included 52 adults with no history of knee injury. Reliability came out to be to be 0.88(45). Q-angle at knee is assessed by asking the patient to assume supine position with hip and knee extended at treatment table, arms by the side of the body, foot is always in neutral position with isometric contraction of rectus femoris. The bony landmarks that are used to assess Q-angle are anterior superior iliac spine, tibial tuberosity, and patella. In first session, 2 and 4 weeks after treatment sessions.

  3. Goniometry:

    Time frame: 4th Week

    It was used to assess knee joint range of motion with a reliable and valid tool goniometer. It has a fulcrum and 2 arm that are used to measure the angle. Reliability is found out to be 0.92-0.99 which is categorized as good reliability.

    In this study goniometer was used to find out Q-angle, knee flexion ROM and knee extension ROM for each patient in both control and experimental groups. For Q-angle measurement the center point was placed at center of patella, the proximal arm was placed parallel to anterior superior iliac spine and distal arm was placed at tibial tuberosity of the patient. In first session, 2 and 4 weeks after treatment sessions.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Compressive Myofascial Release of Vastus Lateralis on Lateral Patellar Tracking in Patients With Knee Osteoarthritis.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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