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Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

Primary Purpose

Non Specific Knee Osteoarthritis Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Combination therapy (CT)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Specific Knee Osteoarthritis Pain

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Madonna Noshi Welson Aiad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intervention

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knee Range Of Motion
electronic goniometer it measures range of motion objectively assess ROM for extremities and digits

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2022
Last Updated
May 8, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05529446
Brief Title
Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women
Official Title
Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Knee Osteoarthritis Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Combination therapy (CT)
Intervention Description
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 Outcome Measure Information:
Title
Knee Range Of Motion
Description
electronic goniometer it measures range of motion objectively assess ROM for extremities and digits
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
activity of daily living
Description
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
Time Frame
up to four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Madonna Noshi Welson Aiad
City
Cairo
ZIP/Postal Code
00000
Country
Egypt

12. IPD Sharing Statement

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Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

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