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Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Mulligan's mobilization with movement MWM added isometric strength training
Sponsored by
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteo Arthritis Knee focused on measuring Isometric exercise, Osteoarthritis, Rehabilitation

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with knee OA with radiological evidence of grade 2 or 3 of the Kellgren and Lawrence scale.
  • Age between 40-65 years, unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included), and pain in and around the knee.

Exclusion Criteria:

  • Patient will be excluded, if they had any deformity of the knee, hip, or back, had any central or peripheral nervous system involvement.
  • They had received steroids or intra-articular injection within the previous three months, uncooperative patients.

Sites / Locations

  • Rehabilitation center, Majmaah UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Mulligan's mobilization with movement added isometric strength training will be given 3 days a week for six weeks.

Mobilization-added isometric strength training will be given 3 days a week for six weeks.

Outcomes

Primary Outcome Measures

pain intensity
Visual Analogue scale on 0 to10 cm
Range of Motion
Standard goniometer.
Western Ontario and McMaster universities osteoarthritis (WOMAC) index
Western Ontario and McMaster universities osteoarthritis scale

Secondary Outcome Measures

Full Information

First Posted
December 7, 2021
Last Updated
October 10, 2022
Sponsor
Majmaah University
Collaborators
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05577403
Brief Title
Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.
Official Title
Effect of Mulligan's Mobilization With Movement Added With Isometric Exercises on Muscle Strength Pain and Disability Associated With Knee Osteoarthritis: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
February 5, 2023 (Anticipated)
Study Completion Date
March 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
Collaborators
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effect of Mulligan's mobilization with movement in osteoarthritis of the knee.
Detailed Description
Patients with knee OA diagnosed at the orthopaedic clinic of Tumair general hospital and referred to the physiotherapy department who attended the rehabilitation centre of Majmaah university will be recruited. Patients will be excluded if they had knee or hip injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury, had low back-related leg pain, or had any contraindication to manual therapy. The protocol was submitted to and approved by the Majmaah University Research Ethics committee (MUREC Dec.2/ COM-2021/19-3) Participants will be requested to sign a written informed consent form approved by the institutional ethics committee. A total of 60 participants were randomly assigned to group A (experimental group): Mulligan's mobilization with movement MWM added isometric strength training, and group B (control group): Sham MWM added isometric strength training. Pre and post-test readings were taken at baseline, week 2, and week 4, respectively. The outcome measures for this study will be maximal voluntary isometric contraction of quadriceps strength (measured by ISOMOVE dynamometer), ROM, and Western Ontario and McMaster universities osteoarthritis (WOMAC) index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Isometric exercise, Osteoarthritis, Rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation: Randomized
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Mulligan's mobilization with movement added isometric strength training will be given 3 days a week for six weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Mobilization-added isometric strength training will be given 3 days a week for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mulligan's mobilization with movement MWM added isometric strength training
Other Intervention Name(s)
Sham MWM added isometric strength training
Intervention Description
Mulligan's mobilization with movement added isometric exercise: the participants in the experimental group will receive a Mulligan's mobilization with movement added isometric exercise. Treatment will be given for the period of three weeks, for five days a week in both groups. Data will be collected before intervention and after 2nd & 4th week of intervention.
Primary Outcome Measure Information:
Title
pain intensity
Description
Visual Analogue scale on 0 to10 cm
Time Frame
6 weeks
Title
Range of Motion
Description
Standard goniometer.
Time Frame
6 weeks
Title
Western Ontario and McMaster universities osteoarthritis (WOMAC) index
Description
Western Ontario and McMaster universities osteoarthritis scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with knee OA with radiological evidence of grade 2 or 3 of the Kellgren and Lawrence scale. Age between 40-65 years, unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included), and pain in and around the knee. Exclusion Criteria: Patient will be excluded, if they had any deformity of the knee, hip, or back, had any central or peripheral nervous system involvement. They had received steroids or intra-articular injection within the previous three months, uncooperative patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahnaz Hasan, PhD
Phone
+966-536043632
Email
sh.ahmad@mu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Naiyer Shahzad, PhD
Phone
+966-506275989
Email
shahzad.naiyer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahnaz Hasan, PhD
Organizational Affiliation
Majmah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation center, Majmaah University
City
Al Majma'ah
State/Province
Riyadh
ZIP/Postal Code
15341
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahnaz Hasan, PhD
Phone
+966-536043632
Email
sh.ahmad@mu.edu.sa
First Name & Middle Initial & Last Name & Degree
Naiyer Shahzad, PhD
Phone
+966-506275989
Email
shahzad.naiyer@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept secure with the principal investigator (Dr. Shahnaz Hasan) and sub-investigator (Dr. Naiyer Shahzad) due to confidentiality issues.

Learn more about this trial

Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.

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