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

January 27, 2022 updated by: Dow University of Health Sciences

Effects of Hip Joint Mobilizations and Strength Training on Pain, Physical Function and Dynamic Balance in Patients With Knee Osteoarthritis: A Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75400
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hip Joint Mobilizations
Hip joint mobilizations Hip strength training Knee exercises
Other: Hip Joint Mobilizations
i. Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation
Other: Hip joint Muscle strength training
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
Other: knee strengthening and flexibility exercises

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:
Experimental: Hip & Knee Muscles strength training
Hip strength training Knee exercises
Other: Hip joint Muscle strength training
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
Other: knee strengthening and flexibility exercises

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:
Active Comparator: Knee Muscles strength training
Knee exercises
Other: knee strengthening and flexibility exercises

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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: up to 6 weeks
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.
up to 6 weeks
Four step square test
Time Frame: up to 6 weeks
Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.
up to 6 weeks
Koos
Time Frame: up to 6 weeks
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.
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Bushra Mehwish, MSAPT, Dow University of Health Sciences
  • Study Director: Shahzad Ali Syed, MSPT, Dow University of Health Sciences
  • Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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