Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Osteoarthritis (Knee)
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Single (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.Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

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 ...

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

Tracking Information

NCT #
NCT04769531
Collaborators
Not Provided
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