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The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Pulsed electromagnetic field and Progressives resistance exercise
PRE
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Pulsed Electromagnetic Field, Progressive Resistance Exercise

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 40 year-old and above
  • Diagnosed with unilateral or bilateral knee OA

Exclusion Criteria:

  • Patients with current or previous knee surgeries
  • Inflammatory arthritis's (rheumatoid arthritis, gout, etc.)
  • Alzheimer disease
  • Parkinson disease
  • Unable to walk unaided for 6 months

To maximize the efficiency of our experiments we excluded patients if they:

  • Have participated in progressive resistance training or received pulsed electromagnetic field treatment in the prior year
  • Exercise regularly more than once a week.

Sites / Locations

  • Mohammad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEMF and PRE

PRE

Arm Description

The PEMF and PRE group received 24 sessions (3 sessions/week for 8 weeks) of combined treatment group (pulsed electromagnetic field with PRE training)

The PRE group received 24 sessions (3 sessions/week for 8 weeks) of only progressive resistance exercise

Outcomes

Primary Outcome Measures

Change Scores of The Knee Injury and Osteoarthritis Outcome Score
is knee-specific instrument , developed to assess the patients opinion about their knee and associated problems. the Knee Injury and osteoarthritis outcome Score(KOOS) evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored sub-scales; pain, other symptoms , functions in daily living (ADL), Function in sport and Recreation (sport/Rec), and knee-related Quality of Life (QOL). An Arabic version of KOOS has been found to be valid and reliable was used in our study[8]
Change Scores of The Short Physical Performance Battery (SPPB)
The SPPB assesses lower extremity function and has 3 components: walking gait speed, standing balance, and time to complete 5 chair stands. The total score is the sum of the three tests scores. The total score will be the variable used during data analysis. The SPPB has demonstrated good intra and inter-tester reliability, responsiveness, and validity[9,10]

Secondary Outcome Measures

Change Scores of The Numeric pain rating scale (NPRS)
The NPRS is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". Patients are instructed to choose a single number from the scale that best indicates their level of pain. The Arabic version of NPRS has shown good to excellent test-retest reliability and validity for patients with knee OA.[11]
Change Scores of The RAND-36 health survey
The RAND-36 (identical items of SF-36 health survey with different scoring system) is an easily administered health status and quality of life self-reported measure. It consists of 36-items that assess eight health concepts: general health perceptions, physical functioning, limitations of activities due to physical health problems, limitations of activities due to emotional problems, bodily pain, social functioning, energy and emotional well-being. A valid and reliable Arabic version of RAND-36 health survey was used in our study.[12]

Full Information

First Posted
July 14, 2019
Last Updated
December 12, 2021
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04106986
Brief Title
The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis
Official Title
The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2019 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of pulsed electromagnetic field and progressive resistance exercise on Knee Osteoarthritis. It is experimental research study that look at the additive effect of pulsed electromagnetic field and progressive resistive exercise on pain level, patient-reported and performance-based physical function and Quality of life for patients with knee osteoarthritis
Detailed Description
Background: osteoarthritis is the main cause of disability in elderly population.[1,2] It affects almost one third of individuals aged 65 and older and approximately 25% of osteoarthritis patients 60 years and older cannot perform activities of daily living.[3] The clinical symptoms that lead to disability in Knee osteoarthritis are more frequent than all other joint complaint. A large body of evidence exists proving the beneficial effects of progressive resistance exercise (PRE) in patients with knee osteoarthritis (OA).[4,5,6] Pulse electromagnetic field(PEMF) is a physical therapy modality that could be used for treating knee osteoarthritis (OA) and there emerging evidence suggesting its beneficial effect in reducing pain and improving function for knee osteoarthritis (OA)[7] The purpose of the study is to examine the effectiveness of using pulsed electromagnetic field (PEMF) with progressive resistance exercise (PRE) training in decreasing pain level ,improving physical function, and improving quality of life in patients with Knee osteoarthritis (OA) A small randomized control trial conducted to recruit 32 patients with knee osteoarthritis (OA). Participants with knee osteoarthritis (OA) as defined by American College of Rheumatology recruited from Prince Basma Educational Hospital. Eligible patients were randomly assigned to receive 24 sessions (3 sessions/week for 8 weeks) of either the combined (PRE and PEMF) treatment or PRE only. Participants will be evaluated at baseline, after the end of treatment protocol (8 weeks), and at 3 and 6 months follow up. Mixed ANOVA and repeated measure ANOVA will be used to evaluate the differences between groups in pain, and physical function, and quality of life

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Pulsed Electromagnetic Field, Progressive Resistance Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial study to investigate the effect of pulsed electromagnetic field and progressive resistance exercise on knee osteoarthritis regard pain level ,physical function, and quality of life
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators and outcome assessor are blinded to subject assigned group
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEMF and PRE
Arm Type
Experimental
Arm Description
The PEMF and PRE group received 24 sessions (3 sessions/week for 8 weeks) of combined treatment group (pulsed electromagnetic field with PRE training)
Arm Title
PRE
Arm Type
Experimental
Arm Description
The PRE group received 24 sessions (3 sessions/week for 8 weeks) of only progressive resistance exercise
Intervention Type
Combination Product
Intervention Name(s)
Pulsed electromagnetic field and Progressives resistance exercise
Intervention Description
The pulsed electromagnetic field treatment consist of 30 minutes pulsed electromagnetic field with 50 Hz pulses The progressive resistance exercise training consist of 45 minutes of progressive resistance exercise protocol as the following: The PRE session begun with warm-up exercises that included riding a stationary ergometer for 5 minutes followed by stretching exercises for the hamstrings, quadriceps and gastrocnemius muscles. After this, subjects performed non-weight bearing (open chain) and weight bearing (closed chain) quadriceps exercises. The amount of resistance and number of repetitions for each exercise are based on a modification of the daily adjustable progressive resistance exercise (DAPRE) program that was described by Knight eta al.
Intervention Type
Other
Intervention Name(s)
PRE
Intervention Description
The progressive resistance exercise training consist of 45 minutes of progressive resistance exercise protocol as the following: The PRE session begun with warm-up exercises that included riding a stationary ergometer for 5 minutes followed by stretching exercises for the hamstrings, quadriceps and gastrocnemius muscles. After this, subjects performed non-weight bearing (open chain) and weight bearing (closed chain) quadriceps exercises. The amount of resistance and number of repetitions for each exercise are based on a modification of the daily adjustable progressive resistance exercise (DAPRE) program that was described by Knight eta al.
Primary Outcome Measure Information:
Title
Change Scores of The Knee Injury and Osteoarthritis Outcome Score
Description
is knee-specific instrument , developed to assess the patients opinion about their knee and associated problems. the Knee Injury and osteoarthritis outcome Score(KOOS) evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored sub-scales; pain, other symptoms , functions in daily living (ADL), Function in sport and Recreation (sport/Rec), and knee-related Quality of Life (QOL). An Arabic version of KOOS has been found to be valid and reliable was used in our study[8]
Time Frame
Baseline, 4 weeks, 3 and 6 month follow-up
Title
Change Scores of The Short Physical Performance Battery (SPPB)
Description
The SPPB assesses lower extremity function and has 3 components: walking gait speed, standing balance, and time to complete 5 chair stands. The total score is the sum of the three tests scores. The total score will be the variable used during data analysis. The SPPB has demonstrated good intra and inter-tester reliability, responsiveness, and validity[9,10]
Time Frame
Baseline, 4 weeks, 3 and 6 month follow-up
Secondary Outcome Measure Information:
Title
Change Scores of The Numeric pain rating scale (NPRS)
Description
The NPRS is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". Patients are instructed to choose a single number from the scale that best indicates their level of pain. The Arabic version of NPRS has shown good to excellent test-retest reliability and validity for patients with knee OA.[11]
Time Frame
Baseline, 4 weeks, 3 and 6 month follow-up
Title
Change Scores of The RAND-36 health survey
Description
The RAND-36 (identical items of SF-36 health survey with different scoring system) is an easily administered health status and quality of life self-reported measure. It consists of 36-items that assess eight health concepts: general health perceptions, physical functioning, limitations of activities due to physical health problems, limitations of activities due to emotional problems, bodily pain, social functioning, energy and emotional well-being. A valid and reliable Arabic version of RAND-36 health survey was used in our study.[12]
Time Frame
Baseline, 4 weeks, 3 and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40 year-old and above Diagnosed with unilateral or bilateral knee OA Exclusion Criteria: Patients with current or previous knee surgeries Inflammatory arthritis's (rheumatoid arthritis, gout, etc.) Alzheimer disease Parkinson disease Unable to walk unaided for 6 months To maximize the efficiency of our experiments we excluded patients if they: Have participated in progressive resistance training or received pulsed electromagnetic field treatment in the prior year Exercise regularly more than once a week.
Facility Information:
Facility Name
Mohammad
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Citations:
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24024017
Citation
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Results Reference
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Citation
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PubMed Identifier
28438380
Citation
Bartholdy C, Juhl C, Christensen R, Lund H, Zhang W, Henriksen M. The role of muscle strengthening in exercise therapy for knee osteoarthritis: A systematic review and meta-regression analysis of randomized trials. Semin Arthritis Rheum. 2017 Aug;47(1):9-21. doi: 10.1016/j.semarthrit.2017.03.007. Epub 2017 Mar 18.
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24792947
Citation
Bennell KL, Dobson F, Hinman RS. Exercise in osteoarthritis: moving from prescription to adherence. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):93-117. doi: 10.1016/j.berh.2014.01.009.
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Nicolakis P, Kollmitzer J, Crevenna R, Bittner C, Erdogmus CB, Nicolakis J. Pulsed magnetic field therapy for osteoarthritis of the knee--a double-blind sham-controlled trial. Wien Klin Wochenschr. 2002 Aug 30;114(15-16):678-84.
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The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis

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