Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Non Specific Knee Osteoarthritis Pain
• Intervention / Treatment: Device: Combination therapy (CT)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: madonna N aiad, bachelor; Phone Number: giza,egypt 01284941475; Email: donna.noshi@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 00000
    • Madonna Noshi Welson Aiad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; 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.	Device: Combination therapy (CT); Two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US & TENS where this approach was effective in pain modulation
Sham Comparator: control; 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.	Device: Combination therapy (CT); Two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US & TENS where this approach was effective in pain modulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range Of Motion	electronic goniometer it measures range of motion objectively assess ROM for extremities and digits	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
activity of daily living	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	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: p.t.REC/012/003571

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No