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Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hip Joint Mobilizations
Hip joint Muscle strength training
knee strengthening and flexibility exercises
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee Osteo-arthritis, Musculoskeletal, lower extremity manual therapy, clinical trial Manual therapy, Resistance training, posture

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with unilateral or bilateral knee OA.
  • Subjects of 50 years or above
  • palpable bony enlargement
  • Crepitus on knee motion
  • morning stiffness for less than 30 minutes
  • Kellgren and Lawrence scale: Grade 1-3

Exclusion Criteria:

  • Patients with spinal surgery
  • lower extremity arthroplasty
  • Severe joint contractures and bony deformities of lower extremity
  • Amputation of lower extremity
  • Recent trauma to lower extremity
  • A cortisone injection to the hip/ knee within previous 30 days
  • Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
  • Patient with lower extremity bony deformities either acquired or congenital
  • Patient with advanced hip OA.
  • Systemic arthritis or rheumatoid arthritis

Sites / Locations

  • Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Hip Joint Mobilizations

Hip & Knee Muscles strength training

Knee Muscles strength training

Arm Description

Hip joint mobilizations Hip strength training Knee exercises

Hip strength training Knee exercises

Knee exercises

Outcomes

Primary Outcome Measures

Visual analog scale
Visual analog scale (VAS) is a tool evaluating subjective attitudes that cannot be directly measurable, it has a good Test-retest reliability. This scoring range from 0 to 10 cm, Where 0 stands for no pain and 10 indicates worse possible pain.
Four step square test
Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.
Koos
The Knee Injury and Osteoarthritis Outcome Score is a PROM having five sub scales used for knee osteoarthritis (OA), it monitors the course of disease and final outcomes following interventions. Each subscale is scored from 0 (extreme problems) to 100 (no problems). It has high test-retest reliability.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2021
Last Updated
January 27, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04769531
Brief Title
Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis
Official Title
Effects of Hip Joint Mobilizations and Strength Training on Pain, Physical Function and Dynamic Balance in Patients With Knee Osteoarthritis: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow University of Health Sciences

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
Knee osteoarthritis has been ranked 11th highest contributor to non-fatal burdens in the world. Many research studies have discussed the relationship of hip muscle with knee joint stating that impaired hip strength can be a reason for knee pain. Furthermore, mobilization has been shown to be helpful in reducing pain, increasing range of motion and physical function in Osteoarthritis. Despite the evidence, there are very few studies that actually conducted clinical trials to test the effectiveness of mobilizations and strengthening of hip muscles in knee Osteoarthritis. Therefore our aim is to evaluate the effectiveness of hip joint mobilizations and strength training in knee osteoarthritis. OBJECTIVE: To determine the effects of hip joint mobilizations and strengthening exercises, on pain, physical function and dynamic balance in patients with knee osteoarthritis (OA) using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and four square step test. METHODOLOGY: A randomized control trial will be conducted on 66 subjects with knee osteoarthritis and age 50 years will be enrolled in this study after screening by referring consultants. This study will be carried out at Physiotherapy OPD of DUHS, Civil hospital Karachi and Rabia Moon Memorial Institute of Neurosciences Trust. Subjects will be assessed at baseline and after 18 sessions using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and square step test for pain, physical functioning and dynamic balance respectively. The subjects will be allocated into three groups through simple random sampling. Group A (joint mobilization group) will receive hip mobilization techniques, hip strengthening exercises along with the best available knee exercises while group B (hip muscles strengthening group) will receive hip-strengthening exercises with the best available knee exercises. Group C (knee strengthening group) will be receiving the best available knee treatment including exercises only. Patients will receive a total of 18 sessions, 5 treatment sessions per week for four successive weeks. The data will be entered and analyzed using SPPS version 21. Repeated mean one way ANOVA will be applied to measure VAS and KOOS scores within the group, for pairwise comparison between groups, Tukey's test will be applied. Chi-square will be applied for FSST scoring. A P-Value less than 0.5 will be considered significant.
Detailed Description
STUDY DESIGN: A randomized control trial STUDY SETTING: The study will be carried out at an outpatient department of the Institute of Physical Medicine and Rehabilitation, Civil hospital and Rabia Moon Memorial Institute of Neurosciences Trust, Karachi STUDY DURATION: The duration of the study is 6 months after the approval of the synopsis. Each subject will receive a total of 18 sessions, 5 treatment sessions per week over the period of 4 weeks. Each treatment session accounts for 30-45 minutes. STUDY POPULATION: Subjects with knee osteoarthritis who fulfilled the following study inclusion and exclusion criteria: INCLUSION CRITERIA Patients with unilateral or bilateral knee OA. Subjects of 50 years or above palpable bony enlargement Crepitus on knee motion morning stiffness for less than 30 minutes Kellgren and Lawrence scale: Grade 1-3 EXCLUSION CRITERIA Patients with spinal surgery lower extremity arthroplasty Severe joint contractures and bony deformities of the lower extremity Amputation of lower extremity Recent trauma to lower extremity A cortisone injection to the hip/ knee within the previous 30 days Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica Patient with lower extremity bony deformities either acquired or congenital Patient with advanced hip OA. Systemic arthritis or rheumatoid arthritis SAMPLE SIZE: Total 66 patients will be carried out, 22 in each group that include 2 patients as a drop out per group. Using PASS version 11 software, two independent sample t-test and 95% confidence interval 80% power of the test, mean ± S.D of VAS in group A is 4.67 ± 1.59 and group B is 3.6 ± 1.06. The calculated sample size is 27 per group. But due to the unavailability of patients, we will take 22 patients per group within 6 months. SAMPLING TECHNIQUE: Non- probability purposive sampling technique. Treatment will be allocated normally using a random number sheet generated by a statistician. DATA COLLECTION PROCEDURE: Data collection will begin right after the approval. Subjects fulfilling the inclusion criteria will be selected. Informed consent would be obtained after explaining the study objectives and procedure. Each enrolled patient will be randomly allocated using a computer-generated random number list in group A or group B or group C. All patients will be blinded to the type of intervention. The outcome measures would be used to collect data from all participants. The Visual analog scale for pain intensity, Knee injury and osteoarthritis outcome score for physical functions along with four-step square test for dynamic balance would be used and recorded. Outcome results would be obtained at the baseline before starting the treatment after 3 weeks as a follow-up and after 6 weeks after the completion of the study. The study will be carried out for 6 weeks. 18 sessions of 30-45 minutes will be given. Every attempt within ethical constraints will be made to obtain and record outcome data. If symptoms precipitate, subjects will be advised to use a hot pack or cold pack and prescribe an analgesic to control pain and discomfort. STUDY VARIABLES i DEPENDENT: VAS, KOOS, FFST ii. INDEPENDENT: Age, gender, strengthening, mobilization STATISTICAL ANALYSES: For pair-wise comparison between groups, repeated mean one-way ANOVA will be applied and if there is any difference we will apply Tukey's test. For within-group, chi-square and repeated one-way ANOVA will be applied for FSST and VAS, KOOS respectively. Baseline, midline and final readings will be taken for each group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee Osteo-arthritis, Musculoskeletal, lower extremity manual therapy, clinical trial Manual therapy, Resistance training, posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized control trial. Total 66 patients will be carry out, 22 in each of the three groups that include 2 patients as a drop out per group. There will be two interventional groups and one control group. Treatment will be allocated normally using random number sheet generated by statistician.
Masking
Participant
Masking Description
After enrolling the patient, informed consent will be taken from each taken. All patients will be blinded to the type of information to avoid biasness.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip Joint Mobilizations
Arm Type
Experimental
Arm Description
Hip joint mobilizations Hip strength training Knee exercises
Arm Title
Hip & Knee Muscles strength training
Arm Type
Experimental
Arm Description
Hip strength training Knee exercises
Arm Title
Knee Muscles strength training
Arm Type
Active Comparator
Arm Description
Knee exercises
Intervention Type
Other
Intervention Name(s)
Hip Joint Mobilizations
Intervention Description
i. Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation
Intervention Type
Other
Intervention Name(s)
Hip joint Muscle strength training
Intervention Description
i. Hip abduction in side-lying ii. Hip extension in the prone position iii. Sideways walk iv. Hip abduction in stand up position v. Hip hitching
Intervention Type
Other
Intervention Name(s)
knee strengthening and flexibility exercises
Intervention Description
i. STRENGTHENING EXERCISES: Knee extension static quads set, terminal knee extension while standing up, sitting leg press, partial squat, step-ups. ii. STRETCHING EXERCISES:: stretching of the calf, hamstring, and quadriceps-femoris. iii. RANGE OF MOTION EXERCISES: Knee in mid-flexion to full-extension, Knee in mid-flexion to full-flexion:
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Visual analog scale (VAS) is a tool evaluating subjective attitudes that cannot be directly measurable, it has a good Test-retest reliability. This scoring range from 0 to 10 cm, Where 0 stands for no pain and 10 indicates worse possible pain.
Time Frame
up to 6 weeks
Title
Four step square test
Description
Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.
Time Frame
up to 6 weeks
Title
Koos
Description
The Knee Injury and Osteoarthritis Outcome Score is a PROM having five sub scales used for knee osteoarthritis (OA), it monitors the course of disease and final outcomes following interventions. Each subscale is scored from 0 (extreme problems) to 100 (no problems). It has high test-retest reliability.
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unilateral or bilateral knee OA. Subjects of 50 years or above palpable bony enlargement Crepitus on knee motion morning stiffness for less than 30 minutes Kellgren and Lawrence scale: Grade 1-3 Exclusion Criteria: Patients with spinal surgery lower extremity arthroplasty Severe joint contractures and bony deformities of lower extremity Amputation of lower extremity Recent trauma to lower extremity A cortisone injection to the hip/ knee within previous 30 days Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica Patient with lower extremity bony deformities either acquired or congenital Patient with advanced hip OA. Systemic arthritis or rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bushra Mehwish, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahzad Ali Syed, MSPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75400
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis

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