Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

NCT ID: NCT05529446

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-04-15

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.

Conditions

Non Specific Knee Osteoarthritis Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Combination therapy (CT)

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Combination therapy (CT)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Madonna Noshi Welson Aiad

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Madonna Noshi Welson Aiad

Cairo, , Egypt

Countries

Egypt

Other Identifiers

p.t.REC/012/003571

Identifier Type: -

Identifier Source: org_study_id