AzTrials
AzTrials

Knee OsteoarthritisNCT04106986

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

A study testing Pulsed electromagnetic field and Progressives resistance exercise and PRE in people with Knee Osteoarthritis, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Pulsed electromagnetic field and Progressives resistance exercise and PRE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteJordan
Study dates
24 Mar 2019to 22 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Mohammad

    Irbid, 22110

Other trials in Jordan

About this study

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

Read the 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

Being tested
Pulsed electromagnetic field and Progressives resistance exercise, PRE
Keywords
Knee osteoarthritis, Pulsed Electromagnetic Field, Progressive Resistance Exercise
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsed electromagnetic field and Progressives resistance exerciseCombination 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.

  • PREOther

    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.

Study groups in NCT04106986
Study groupRoleWhat they receive
PEMF and PREExperimentalThe PEMF and PRE group received 24 sessions (3 sessions/week for 8 weeks) of combined treatment group (pulsed electromagnetic field with PRE training)
Receives: Combination Product: Pulsed electromagnetic field and Progressives resistance exercise
PREExperimentalThe PRE group received 24 sessions (3 sessions/week for 8 weeks) of only progressive resistance exercise
Receives: Other: PRE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: Baseline, 4 weeks, 3 and 6 month follow-up

  2. 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]

    Measured: Baseline, 4 weeks, 3 and 6 month follow-up

Secondary outcomes (2)

  1. 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]

    Measured: Baseline, 4 weeks, 3 and 6 month follow-up

  2. 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]

    Measured: Baseline, 4 weeks, 3 and 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start24 Mar 2019
  3. Primary completion22 Jan 2020
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04106986
Sponsor's protocol ID
43/120/2019
Status last verified
Dec 2021
First submitted
14 Jul 2019
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 24024017

  • 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.

    PubMed 21684382

  • 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.

    PubMed 18163497

  • 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.

    PubMed 28438380

  • 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.

    PubMed 24792947

  • 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.

    PubMed 28332010

  • 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.

    PubMed 12602111

  • 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.

    PubMed 9699158

  • 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.

    PubMed 10811152

  • 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.

    PubMed 7838189

  • 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.

    PubMed 26733318

  • 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.

    PubMed 9520966

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed electromagnetic field and Progressives resistance exercise and PRE in people with Knee Osteoarthritis, run by Jordan University of Science and Technology at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Scores of The Knee Injury and Osteoarthritis Outcome Score (time frame: Baseline, 4 weeks, 3 and 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04106986, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in