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

December 12, 2021 updated by: Jordan University of Science and Technology
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Mohammad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMF and PRE
The PEMF and PRE group received 24 sessions (3 sessions/week for 8 weeks) of combined treatment group (pulsed electromagnetic field with PRE training)
Combination product: Pulsed electromagnetic field and Progressives resistance exercise

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Scores of The Knee Injury and Osteoarthritis Outcome Score
Time Frame: Baseline, 4 weeks, 3 and 6 month follow-up
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]
Baseline, 4 weeks, 3 and 6 month follow-up
Change Scores of The Short Physical Performance Battery (SPPB)
Time Frame: Baseline, 4 weeks, 3 and 6 month follow-up
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]
Baseline, 4 weeks, 3 and 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Scores of The Numeric pain rating scale (NPRS)
Time Frame: Baseline, 4 weeks, 3 and 6 month follow-up
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]
Baseline, 4 weeks, 3 and 6 month follow-up
Change Scores of The RAND-36 health survey
Time Frame: Baseline, 4 weeks, 3 and 6 month follow-up
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]
Baseline, 4 weeks, 3 and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2019

Primary Completion (Actual)

January 22, 2020

Study Completion (Actual)

January 22, 2020

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43/120/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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