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Effects of Compression Mobilization in OA Patients

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physiotherapy
compression mobilization
Sponsored by
Mir Arif Hussain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring NPRS, mBBS, MMT, O.A

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age Limit 30 to 60
  • Unilateral OA Knee
  • Moderate OA

Exclusion Criteria:

  • No Associated Bone Disease
  • Lumber Radiculopathy
  • Osteoporosis
  • Any MSK Deformity

Sites / Locations

  • Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

It includes ultrasound therapy, glides, exercises and home plan.

It includes ultrasound therapy, glides, exercises, compression mobilization and home plan.

Outcomes

Primary Outcome Measures

Vernier Calliper For Joint Gap Measurement.
Vernier caliper, instrument for making very accurate linear measurements introduced in 1631 by Pierre Vernier of France. It can be used for joint space via x-ray radiograph of a joint.
Numeric Pain Rating Scale
Numeric pain rating scale is a scale used to quantify pain intensity. It is divided into eleven equal parts; for example 0 - 10. O means that there is no pain at all, 1 - 3 divisional range falls in the mild category pain , 4 - 6 indicates the symptoms of moderate pain while 7 - 10 reading symptoms the severity of pain.
Goniometry for knee ROM
The Range of motion was assessed by Goniometer. The placement of goniometer for flexion as follows the Axis of goniometer was placed at lateral epicondyle of femur laterally , stationary arm was along femur and the moving arm was along the fibula and the patient position was supine then ask the patient to flex knee until hip flexion came up to 90 degrees while monitors the measurements through goniometer .
Modified Berg Balance tool
The Berg Balance Scale (BBS) is based on 14 items common to daily life activities used to evaluate functional balance .here berg balance scale is used to assess patients proprioception through different tasks.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2021
Last Updated
September 2, 2021
Sponsor
Mir Arif Hussain
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1. Study Identification

Unique Protocol Identification Number
NCT04944056
Brief Title
Effects of Compression Mobilization in OA Patients
Official Title
Effect of Compression Mobilization (Kaltenborn Technique) in Knee Osteoarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
July 11, 2021 (Actual)
Study Completion Date
July 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mir Arif Hussain

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 Design was randomized control trial in which data was collected From Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT. Convenient sampling technique was used for data collection. 39 patients having knee osteoarthritis were recruited in this study. After taking consent from patients, patients were divided randomly into two groups through lottery method. The Experimental Group received compression mobilization with Conventional Physiotherapy (n = 19) and the Control group received Conventional Physiotherapy (n = 20). Research data was collected through structural questionnaire. the main variables were ROM, MMT, Muscle length and mBBS.
Detailed Description
Osteoarthritis (OA) is a disease which since long times is considered to be a "wear and tear" malfunctioning disease leading to a loss of cartilage. Osteoarthritis is considered as a "degenerative joint disease Osteoarthritis is a term used for disease in which destruction of cartilage is involved (articular), with a bone thickening (subchondral) and formation of new bone. . Joint swelling is also considered as one significant clinical feature of osteoarthritis attributes to inflammation. Osteoarthritis is one of the most common type in arthritis as well as the major cause of chronic musculoskeletal pain. In addition it is attributed to mobility disability in the elder or high aged population all over the world. If we have a glimpse of Asia, prevalence rate of knee osteoarthritis is believed to be higher in the elder population most probably in women. Susan et all conducted a mega level study related to symptomatic OA, where it has been observed that there is an increasing shift in the incidental rates of OA with the age. So, it was concluded that incidence related to knee OA in women limiting the age between 70-89, approached per year is 1% in women and they had the higher rates as compared to males, especially once they are over 50 years of age. Levelling-off or declining shift tends to occur for both groups approximately at the age of 80. Research says that in China, this prevailing rate of mentioned osteoarthritis disease is 7.50%, with a ratio of 10.9 & 13.6% in males and females respectively. Bangladesh and India reports 5.80 & 10.20% respectively. Now considering mainland of Pakistan, 28% urban whereas 25% rural population suffer this particular disease. Women are likely to suffer more with the OA as compared to men and they also tend to undergo the disease of OA with more severity. The marked increase of OA in females at menopause stages has directed towards investigational hypothesis that hormonal imbalance factor may perform a significant role for the developing of OA. However, results appearing on estrogen effects, either it's endogenous or exogenous, on OA as revealed from various observational researches have been contradictory. In a randomize clinical trials(the Heart and Estrogen/Progestin Replacement Study) considering the group of elder postmenopausal females suffering from heart disease, none significant variation was observed in persistence of knee pain or any associated disability while comparing those undergoing estrogen plus progestin therapy or those taking placebo. The prevalence of OA disease and joints patterns that are effected by OA possibly vary amongst the ethnic and racial groups. The frequency of Hand and Hip OA was found remarkably less in Chinese, concluded in the Beijing Osteoarthritis Study, in resemblance to whites researched under Framingham Study. it's important to mention that Chinese females observed under the Beijing Osteoarthritis Study had considerably high prevalence of both symptomatic knee OA and radiographic knee OA as compared to white females at Framingham Study. Results while having consideration of Johnston County Osteoarthritis Project have showed the prevalence of hip OA in African American females(23%) was similar to that in white ladies (22%), with a conclusion that prevalence was a bit higher in African American men (21%) than that in white. Result of various studies showed that dietary factor is a subject of considerable interest related to OA affected individuals. Vitamin D is considered as most advantageous nutritional factor for OA patients. Insufficiency of this specified vitamin will lead to bones thinness, brittleness or any mishaps. Corpulence (Obesity leading to overweight) have since long been predicted as the most potent risk factor to OA, especially knee OA. A more consistence and reliable evidence found is that the alarming effects occurs due to obesity are the risks of bi-lateral radiography and symptomatic hip OA. So, it is considered that application of increased loads on joints is probably a major cause, but not necessarily, a mechanism by which the obesity results into hip or knee OA. Whereas, an application of overloading the knee and hip joints could possibly directed towards synovial joint breakdown and failure of ligamentous as well as other structural support. A lot many studies provides evidence that knee injury is surely one of the strongest factor for risking OA. Severe conditions of injury to joints structures, particularly mentioning the meniscal tear that requiring meniscectomy, or trans-articular fracture or anterior cruciate ligament injury; may these all results into increased risk involvement of OA development and also musculoskeletal symptomatology. Repeated use of particular joints for work is marked with the increasing risk of OA. The risk factor involved in the development of knee OA was at least two times more for men whose consistency in jobs require both kneeling and carrying or squatness in a mid-life would definitely have more risk of developing OA by the nature of their commitments as compared to women whose job commitments do not offer these physical activities in common. Therefore, its a must mention that knee OA risks which are associated with squatness or kneeling are much higher amongst those who are overweighed or who are indulgent in lifting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
NPRS, mBBS, MMT, O.A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experimental Group received compression mobilization with Conventional Physiotherapy and the control group received Conventional Physiotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
It includes ultrasound therapy, glides, exercises and home plan.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
It includes ultrasound therapy, glides, exercises, compression mobilization and home plan.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
Ultrasound therapy 3-4 minutes. Tibiofemoral AP and PA glides 1 set x10reps x 3 sets. Patellar glides 1 set x 5 reps x 3 sets. Quads isometrics 1 set x 10 reps. Hams self stretching 1 sets x 10 reps. Home plan: Quads isometrics 1 set x 10 reps. Hams self stretching 1 sets x 10 reps. Active range of motion.
Intervention Type
Other
Intervention Name(s)
compression mobilization
Intervention Description
Ultrasound therapy 3-4 minutes. Tibiofemoral AP and PA glides 1 set x10reps x 3 sets. Patellar glides 1 set x 5 reps x 3 sets. Quads isometrics 1 set x 10 reps. Hams self stretching 1 sets x 10 reps. Compression mobilization 1 set x 10 reps x 3sets. Home plan: Quads isometrics 1 set x 10 reps. Hams self stretching 1 sets x 10 reps. Active range of motion.
Primary Outcome Measure Information:
Title
Vernier Calliper For Joint Gap Measurement.
Description
Vernier caliper, instrument for making very accurate linear measurements introduced in 1631 by Pierre Vernier of France. It can be used for joint space via x-ray radiograph of a joint.
Time Frame
2 weeks
Title
Numeric Pain Rating Scale
Description
Numeric pain rating scale is a scale used to quantify pain intensity. It is divided into eleven equal parts; for example 0 - 10. O means that there is no pain at all, 1 - 3 divisional range falls in the mild category pain , 4 - 6 indicates the symptoms of moderate pain while 7 - 10 reading symptoms the severity of pain.
Time Frame
2 weeks
Title
Goniometry for knee ROM
Description
The Range of motion was assessed by Goniometer. The placement of goniometer for flexion as follows the Axis of goniometer was placed at lateral epicondyle of femur laterally , stationary arm was along femur and the moving arm was along the fibula and the patient position was supine then ask the patient to flex knee until hip flexion came up to 90 degrees while monitors the measurements through goniometer .
Time Frame
2 weeks
Title
Modified Berg Balance tool
Description
The Berg Balance Scale (BBS) is based on 14 items common to daily life activities used to evaluate functional balance .here berg balance scale is used to assess patients proprioception through different tasks.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age Limit 30 to 60 Unilateral OA Knee Moderate OA Exclusion Criteria: No Associated Bone Disease Lumber Radiculopathy Osteoporosis Any MSK Deformity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeeba Shahzadi, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT
City
Islamabad
State/Province
Capital
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23194896
Citation
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Citation
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Citation
Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
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PubMed Identifier
2712610
Citation
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Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of osteoarthritis in Asia. Int J Rheum Dis. 2011 May;14(2):113-21. doi: 10.1111/j.1756-185X.2011.01608.x.
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Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141.
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Nelson AE, Braga L, Renner JB, Atashili J, Woodard J, Hochberg MC, Helmick CG, Jordan JM. Characterization of individual radiographic features of hip osteoarthritis in African American and White women and men: the Johnston County Osteoarthritis Project. Arthritis Care Res (Hoboken). 2010 Feb;62(2):190-7. doi: 10.1002/acr.20067.
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Effects of Compression Mobilization in OA Patients

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