Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

Not Applicable

Completed

• Conditions: Non Specific Knee Osteoarthritis Pain
• Interventions: Device: Combination therapy (CT)

• Registration Number: NCT05529446
• Lead Sponsor: Cairo University

Brief Summary

the aim of this study is to investigate the efficacy of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

Detailed Description

Osteoarthritis (OA) is the most common musculoskeletal condition affecting the quality of life of older adults. The prevalence of OA is very high 45% in females in comparison to males, especially after menopause due to the hormonal changes. In the physical therapy practice, therapeutic ultrasound (US) is one of the most frequently applied electrotherapeutic modalities in orthopedics physiotherapy. Simultaneous application of two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US \& Transcutaneous neuromuscular electrical stimulation (TENS )where this approach was effective in pain modulation .The use of combination therapy is highly preferable because of the advantageous effect both electro-therapy and ultrasound provide simultaneously. There are no current studies on using combination therapy in the treatment of pain in mild to moderate knee osteoarthritis in post-menopausal women and we don't know the proper treatment dose.The study is designed as a prospective, randomized, pre-posttest, controlled trial.where we have two groups Intervention group and control. the intervention group will recieve strengthening exercises in addition to combination therapy 10 minutes for each session, 3 times per week, for 3 weeks.The Control group will recieve the same strengthening exercises as intervention group and sham combination therapy 10 minutes for each session, 3 times per week, for 2 weeks.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Forty women who suffer pain out of mild to moderate knee osteoarthritis
• Their age will range from 55 to 65
• At least one year after last menstruation.
• Their BMI will be ranged from 25 to 35 kg/m2

Exclusion Criteria

• Neurological disorders.
• Cardiovascular disorders.
• Severe knee osteoarthritis
• Areas of the body where cancerous lesions exist.
• Any skin impairment at site of application as inflammation, lesion, wounds, infection and swelling.
• Pacemaker and any metallic implants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Combination therapy (CT)	This group will consist of twenty women with mild to moderate osteoarthritis suffering from pain. These women will perform strengthening exercises in addition to combination therapy 10 minutes for each session, 3 times per week, for 3 weeks.
control	Combination therapy (CT)	This group will consist of twenty women with mild to moderate osteoarthritis suffering from pain.These women will perform the same strengthening exercises as intervention group and receive sham combination therapy 10 minutes for each session, 3 times per week, for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Knee Range Of Motion	up to four weeks	electronic goniometer it measures range of motion objectively assess ROM for extremities and digits

Secondary Outcome Measures

Name	Time	Method
activity of daily living	up to four weeks	Western Ontario and McMaster universities arthritis index (WOMAC) It will be used to measure activities of daily living, functional mobility gait, general health and quality of life

Trial Locations

Locations (1)

Madonna Noshi Welson Aiad; 🇪🇬 Cairo, Egypt