NCT Number: NCT07396233
A randomized controlled trial will be conducted at the Department of Physiotherapy, Dr. Ziauddin Hospital and Al-Rayaz Hospital, Karachi, Pakistan. A total of 150 patients diagnosed with knee osteoarthritis, aged between 40-60 years, will be recruited through a non-probability purposive sampling technique. Written informed consent will be obtained from all eligible participants prior to enrollment. The participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group, with 75 participants in each group. Group A (experimental group) will receive diagonal proprioceptive neuromuscular facilitation (PNF) pattern exercises, while Group B (control group) will receive conventional strength training exercises. Heat therapy will be administered to both groups. All participants will be assessed using a standardized assessment form. Outcome measures will include pain intensity, knee range of motion, functional disability, hamstring flexibility, dynamic balance, and fatigue level. A single blinded assessor will assess all participants at baseline and at post intervention. Treatment sessions will be given thrice a week on alternate days for 6 weeks.
Interested in participating?
Request Info40 year–60 year
All sexes
Interventional
Not applicable
Al-Rayaz Hospital, Karachi, Sindh, Pakistan
The Statistical Package for the Social Sciences (SPSS) version 23 will be used for data analysis. Mean and standard deviation will be calculated for quantitative variables such as age. Qualitative variables will be presented as frequencies and percentages. Outcome measures (decrease pain intensity, improve functional disability, increase knee range of motion, improve hamstring flexibility, dynamic balance, and fatigue level) recorded at baseline and after 18th session of intervention will be compared and analyzed. Repeated measures ANOVA will be applied for statistical analysis. A p-value of less than 0.05 will be considered as the level of statistical significance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagonal PNF pattern exercises include Diagonal 1 and Diagonal 2 lower limb pattern movements performed against resistance to improve strength, flexibility, and functional performance.
The conventional strength training exercises include quadriceps and hip abductor strengthening performed using resisted active movements to improve muscle strength and functional ability.
Heat therapy will be given for 10 minutes by the help of electric heating pad.
Time frame: Baseline and after 6 weeks of intervention
The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or assess pain severity in different conditions. It is 0 to 10 cm scale. Patients rate their pain on the scale. Higher the score in centimeter, severe will be the pain experienced.
Time frame: Baseline and after 6 weeks of intervention.
The universal goniometer is an instrument for the precise measurement of range of movement angles in degree, especially one used to measure the angles before and after range of motion. Increase in the degree of angle suggests increase in range of movement.
Time frame: Baseline and after 6 weeks of intervention.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems regarding functional disability. It consists of total 100 scores. Increase in scores suggests better function and decrease in scores suggests increased functional disability.
Time frame: Baseline and after 6 weeks of intervention.
The Active Knee Extension (AKE) test will be used to assess hamstring muscle length using a goniometer with the hip flexion position at 90°. A greater knee extension angle indicates greater hamstring muscle length.
Time frame: Baseline and after 6 weeks of intervention.
The Four Square Step Test will be used to assess dynamic balance. It is measured in seconds. A higher completion times indicate poorer dynamic balance and a greater risk of falls.
Time frame: Baseline and after 6 weeks of intervention.
The multidimensional fatigue inventory is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher total scores correspond with more acute levels of fatigue.
Contact information is provided by the study sponsor or research team.
Basit Ansari, PhD
CONTACT
Rabia Hassan, MSAPT
CONTACT
University of Karachi
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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