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

NCT04106986 | Completed DMC

• 1 other identifier: 43/120/2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Pulsed Electromagnetic Field; Progressive Resistance Exercise

Outcome Measures

Primary Outcomes (2)

• 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\[8\]

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

• 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\[9,10\]

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

Secondary Outcomes (2)

• Change Scores of The Numeric pain rating scale (NPRS)

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

• Change Scores of The RAND-36 health survey

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

Study Arms (2)

PEMF and PRE

EXPERIMENTAL

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

PRE

EXPERIMENTAL

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

Other: PRE

Interventions

Pulsed electromagnetic field and Progressives resistance exercise 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.

PEMF and PRE

PRE 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.

PRE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Mohammad

Irbid, 22110, Jordan

Location

Related Publications (12)

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

  PMID: 24024017 BACKGROUND

• 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.

  PMID: 21684382 BACKGROUND

• 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.

  PMID: 18163497 BACKGROUND

• 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.

  PMID: 28438380 BACKGROUND

• 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.

  PMID: 24792947 BACKGROUND

• 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.

  PMID: 28332010 BACKGROUND

• 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.

  PMID: 12602111 BACKGROUND

• 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.

  PMID: 9699158 BACKGROUND

• 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.

  PMID: 10811152 BACKGROUND

• 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.

  PMID: 7838189 BACKGROUND

• 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.

  PMID: 26733318 BACKGROUND

• 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.

  PMID: 9520966 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and outcome assessor are blinded to subject assigned group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: September 27, 2019
• Study Start: March 24, 2019
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

JO (1)