NCT06459453|Unknown
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Sponsor study identifier
interventional
34
1 country
1
Study Start
November 23, 2023
Actual (reported)Primary Completion
July 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This project was a randomized control trial conducted to check the effects of kaltenborn versus mulligan techniques on pain ,range of motion and functional disability in patients with rheumatoid arthritis of the wrist The inflammatory polyarthritis that primarily affects the tiny joints is a hallmark of rheumatoid arthritis, a chronic autoimmune illness. It is characterized by synovial joint degeneration, joint swelling, and joint discomfort, which can result in disability and early death .All patients of chronic stage,convenience sampling technique was used,subjects following eligibility criteria from Shaikh zayed hospital lahore ,were randomly allocated into two groups ,baseline assessment was done.Group A participants were given Kaltenborn mobilization along with conventional physiotherapy.Group B participants were given Mulligan mobilization along with conventional physiotherapy.Post intervention assessment was done via,VAS(visual analogue scale),goniometric measurements of wrist ranges,and QUICK DASH score.3 sessions per week were given,Data was analyzed by using SPSS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2023
Actual (reported)June 11, 2024
Actual (reported)June 14, 2024
Actual (reported)July 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
VAS(visual analogue scale)
The visual analogue scale measures pain intensity .it consists of a 10cm line, with two end points representing 0 ('no pain')and 10('worst pain').The patient rate their current level of pain by placing a mark on the line. .
4 weeks
GONIOMETER
Goniometer is an instrument used to determine range of motion in patients joint .During rehabilitation, a goniometer would also be used to measure what progress has been achieved in returning back to normal range of motion.In rheumatoid arthritis of the wrist , goniometer measures the range of flexion ,extension ,radial and ulnar deviation of the wrist joint .
4 weeks
QUICK DASH
It is the 11 item questionnaire that measures upper extremity specific symptoms and disability. It can be used to access any region of the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities and the other five items related to quality of sleeping, social activities ,daily activities and the intensity of pain and numbness.
4weeks
Per participant was randomized to receive weekly low grade Kaltenborn manual mobilization(grade I).Any tightening of the connective tissues surrounding the joint gave (grade II) and oscillations followed by additional stretching gave (grade III).For wrist joints, Kaltenborn mobilization was performed to improve wrist flexion, extension ,radial and ulnar deviation.The duration of intervention will be 4 weeks,3 sessions per week, a total of 12 sessions will be given to the study participants.Each session will be last for 30 minutes .Conventional physical therapy will be given to the participants along with the kaltenborn mobilization.
Per participant gave concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient . Mulligan mobilization was performed for wrist flexion and extension,(in the form of a fist)MCP joint flexion and extension,Thumb IC joint flexion and extension ,abduction and adduction of fingers.. The duration of intervention will be 4 weeks,3 sessions per week, a total of 12 sessions will be given to the study participants . Each session will last for 30 minutes .Conventional physical therapy will be given to the participants along with mulligan mobilization.
Per participant was randomized to receive low grade Kaltenborn manual mobilization(grade I).Any tightening of the connective tissues surrounding the joint (grade II) or oscillations followed by additional stretching (grade III).Kaltenborm mobilization is performed for wrist flexion,extension,radial and ulnar deviation.The duration of intervention will be 4 weeks,3 sessions per week, a total of 12 sessions will be given to the study participants. Each session will be last for 30 minutes .Conventional physical therapy will be given to the participants along with kaltenborn.
Shaikh zayed hospital
Lahore, Punjab Province, Pakistan
Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, St Clair EW, Keenan GF, van der Heijde D, Marsters PA, Lipsky PE; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004 Apr;50(4):1051-65. doi: 10.1002/art.20159.
Gavrila BI, Ciofu C, Stoica V. Biomarkers in Rheumatoid Arthritis, what is new? J Med Life. 2016 Apr-Jun;9(2):144-8.
Hajra Anwer
Riphah International University
First Submitted
June 11, 2024
First Posted
June 14, 2024
Study Start
November 23, 2023
Actual (reported)SARAH Exercise Program in Patients With Rheumatoid Arthritis
Per participant gave concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Mulligan mobilization is performed for wrist flexion and extension(in the form of fist)MCP joint flexion and extension,Thumb IC joint flexion and extension, abduction and adduction of fingers, The duration of intervention will be 4weeks,3 sessions per week ,a total of 12 sessions will be given to the study participants .Each session will last for 30 minutes. Conventional physical therapy will be given to the participants along with conventional physiotherapy.
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Targonska-Stepniak B, Grzechnik K, Kolarz K, Gagol D, Majdan M. Systemic Inflammatory Parameters in Patients with Elderly-Onset Rheumatoid Arthritis (EORA) and Young-Onset Rheumatoid Arthritis (YORA)-An Observational Study. J Clin Med. 2021 Mar 14;10(6):1204. doi: 10.3390/jcm10061204.
Carmona L, Villaverde V, Hernandez-Garcia C, Ballina J, Gabriel R, Laffon A; EPISER Study Group. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology (Oxford). 2002 Jan;41(1):88-95. doi: 10.1093/rheumatology/41.1.88.
Guan CM, Beg S. Diet as a Risk Factor for Rheumatoid Arthritis. Cureus. 2023 May 20;15(5):e39273. doi: 10.7759/cureus.39273. eCollection 2023 May.
Ilan DI, Rettig ME. Rheumatoid arthritis of the wrist. Bull Hosp Jt Dis. 2003;61(3-4):179-85.
Lee KA, Min SH, Kim TH, Lee SH, Kim HR. Magnetic resonance imaging-assessed synovial and bone changes in hand and wrist joints of rheumatoid arthritis patients. Korean J Intern Med. 2019 May;34(3):651-659. doi: 10.3904/kjim.2016.271. Epub 2017 Nov 24.
Zelnio E, Taljanovic M, Manczak M, Sudol-Szopinska I. Hand and Wrist Involvement in Seropositive Rheumatoid Arthritis, Seronegative Rheumatoid Arthritis, and Psoriatic Arthritis-The Value of Classic Radiography. J Clin Med. 2023 Mar 30;12(7):2622. doi: 10.3390/jcm12072622.
Papp SR, Athwal GS, Pichora DR. The rheumatoid wrist. J Am Acad Orthop Surg. 2006 Feb;14(2):65-77. doi: 10.5435/00124635-200602000-00002.
Kurko J, Besenyei T, Laki J, Glant TT, Mikecz K, Szekanecz Z. Genetics of rheumatoid arthritis - a comprehensive review. Clin Rev Allergy Immunol. 2013 Oct;45(2):170-9. doi: 10.1007/s12016-012-8346-7.
McInnes IB, O'Dell JR. State-of-the-art: rheumatoid arthritis. Ann Rheum Dis. 2010 Nov;69(11):1898-906. doi: 10.1136/ard.2010.134684.
Korczowska I. Rheumatoid arthritis susceptibility genes: An overview. World J Orthop. 2014 Sep 18;5(4):544-9. doi: 10.5312/wjo.v5.i4.544. eCollection 2014 Sep 18.
Winchester R. The molecular basis of susceptibility to rheumatoid arthritis. Adv Immunol. 1994;56:389-466. doi: 10.1016/s0065-2776(08)60456-3. No abstract available.
Halverson PB. Extraarticular manifestations of rheumatoid arthritis. Orthop Nurs. 1995 Jul-Aug;14(4):47-50. doi: 10.1097/00006416-199507000-00009.
Markusse IM, Dirven L, Gerards AH, van Groenendael JH, Ronday HK, Kerstens PJ, Lems WF, Huizinga TW, Allaart CF. Disease flares in rheumatoid arthritis are associated with joint damage progression and disability: 10-year results from the BeSt study. Arthritis Res Ther. 2015 Aug 31;17(1):232. doi: 10.1186/s13075-015-0730-2.
Zhang C. Flare-up of cytokines in rheumatoid arthritis and their role in triggering depression: Shared common function and their possible applications in treatment (Review). Biomed Rep. 2021 Jan;14(1):16. doi: 10.3892/br.2020.1392. Epub 2020 Nov 19.
Molnar-Kimber KL, Kimber CT. Each type of cause that initiates rheumatoid arthritis or RA flares differentially affects the response to therapy. Med Hypotheses. 2012 Jan;78(1):123-9. doi: 10.1016/j.mehy.2011.10.006. Epub 2011 Nov 1.
Tanski W, Wojciga J, Jankowska-Polanska B. Association between Malnutrition and Quality of Life in Elderly Patients with Rheumatoid Arthritis. Nutrients. 2021 Apr 12;13(4):1259. doi: 10.3390/nu13041259.
Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
Rydholm M, Sharma A, Jacobsson L, Turesson C. The relation between synovitis of individual finger joints and grip force over the first 5 years in early rheumatoid arthritis - a cohort study. Arthritis Res Ther. 2023 Nov 30;25(1):231. doi: 10.1186/s13075-023-03212-6.
Ajeganova S, Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366. Epub 2017 Aug 2.
KELLGREN JH, LAWRENCE JS. Radiological assessment of rheumatoid arthritis. Ann Rheum Dis. 1957 Dec;16(4):485-93. doi: 10.1136/ard.16.4.485. No abstract available.
Primary Completion
July 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 14, 2024
Record last verified: 2024-06
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