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

NCT ID: NCT04106986

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-24

Study Completion Date

2020-01-22

Brief Summary

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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

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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

Conditions

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Knee Osteoarthritis

Keywords

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Knee osteoarthritis Pulsed Electromagnetic Field Progressive Resistance Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigators and outcome assessor are blinded to subject assigned group

Study Groups

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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)

Group Type EXPERIMENTAL

Pulsed electromagnetic field and Progressives resistance exercise

Intervention Type COMBINATION_PRODUCT

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.

PRE

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

Group Type EXPERIMENTAL

PRE

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mohammad

Irbid, , Jordan

Site Status

Countries

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Jordan

References

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Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

Reference Type BACKGROUND
PMID: 24024017 (View on PubMed)

Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.

Reference Type BACKGROUND
PMID: 21684382 (View on PubMed)

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

Reference Type BACKGROUND
PMID: 18163497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28438380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24792947 (View on PubMed)

Loew L, Brosseau L, Kenny GP, Durand-Bush N, Poitras S, De Angelis G, Wells GA. An evidence-based walking program among older people with knee osteoarthritis: the PEP (participant exercise preference) pilot randomized controlled trial. Clin Rheumatol. 2017 Jul;36(7):1607-1616. doi: 10.1007/s10067-017-3606-9. Epub 2017 Mar 22.

Reference Type BACKGROUND
PMID: 28332010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12602111 (View on PubMed)

Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

Reference Type BACKGROUND
PMID: 9699158 (View on PubMed)

Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

Reference Type BACKGROUND
PMID: 10811152 (View on PubMed)

Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.

Reference Type BACKGROUND
PMID: 7838189 (View on PubMed)

Alghadir AH, Anwer S, Iqbal ZA. The psychometric properties of an Arabic numeric pain rating scale for measuring osteoarthritis knee pain. Disabil Rehabil. 2016 Dec;38(24):2392-7. doi: 10.3109/09638288.2015.1129441. Epub 2016 Jan 6.

Reference Type BACKGROUND
PMID: 26733318 (View on PubMed)

Coons SJ, Alabdulmohsin SA, Draugalis JR, Hays RD. Reliability of an Arabic version of the RAND-36 Health Survey and its equivalence to the US-English version. Med Care. 1998 Mar;36(3):428-32. doi: 10.1097/00005650-199803000-00018.

Reference Type BACKGROUND
PMID: 9520966 (View on PubMed)

Other Identifiers

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43/120/2019

Identifier Type: -

Identifier Source: org_study_id