Skip to main content
OpenTrials
Completed

NCT Number: NCT05529446

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Madonna Noshi Welson Aiad

Cairo, 00000, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination therapy (CT)

Device

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

Primary outcomes

  1. Knee Range Of Motion

    Time frame: up to four weeks

    electronic goniometer it measures range of motion objectively assess ROM for extremities and digits

Secondary outcomes

  1. activity of daily living

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.