- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459453
Effects of Kaltenborn Versus Mulligan Techniques in Rheumatoid Arthritis.
June 11, 2024 updated by: Riphah International University
Effects of Kaltenborn Versus Mulligan Techniques on Pain, Range of Motion and Functional Disability in Patients With Rheumatoid Arthritis Of The Wrist.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Rheumatoid arthritis is among the most commonly reported problems to physicians, orthopedics and physical therapist.Even before reporting to clinics there is a long history of using over the counter pain killers.Pain avoidance behaviors let the joint stiff so much that a clinician help is sought.Most times the cause of rheumatoid arthritis is not known therefore it is term as "autoimmune disorder".There is a vast literature regarding the management of rheumatoid arthritis and yet after the decades of research there are gaps in the treatment plan.In modern age of health care it is common goal of every health care to make patient self sufficient as early as possible .The self care model has new treatment protocols 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.
.This study has compared the effectiveness of kaltenborn versus mulligan mobilization on pain,range of motion and functional disabilty in patients with rheumatoid arthitis of the wrist.The current study was narrative in a way that in literature there is no comparison of two different mobilizations about treating rheumatoid arthritis.These two mobilizations were employed to see which is more effective to improve pain,range of motion and functional disability in rheumatoid arthritis of the wrist.
Study Type
Interventional
Enrollment (Estimated)
34
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 Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PhD
- Phone Number: 0515481826
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Recruiting
- Shaikh Zayed Hospital
-
Contact:
- Hajra Anwer
- Phone Number: 03347052438
- Email: hajiraanwer@gmail.com
-
Principal Investigator:
- Aqsa Arshad, Ms-OMPT
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age group between 18 to 65 years. Patients with less than 15degrees of flexion and 30 degrees of extension.
- Male and female both are included.
- Patients with chronic RA.
- Consider only those patients with Ra factor positive. Patients with less than 10degrees of radial deviation and 15 degrees of ulnar deviation.
- Patients willing to participate in the whole treatment session and follow up.
Exclusion Criteria:
- Patients who had any mental illness (Alzheimer's, Parkinson's disease, Dementia etc)
- Patients who had any neurological deficit(paresthesia ,sensory loss, radiculopathy ,myleopathy)
- Peripheral vascular diseases.
- Any history of surgery related to upper limb.
- Patients having metal implants in the upper limbs. Patients with any other serious pathology .
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Kaltenborn Technique
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 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.
|
|
Experimental: Mulligan Technique
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS(visual analogue scale)
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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
Time Frame: 4weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hajra Anwer, Riphah International University
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Ann Rheum Dis. 2011 Feb;70(2):399.
- 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.
- 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.
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)
November 23, 2023
Primary Completion (Estimated)
July 5, 2024
Study Completion (Estimated)
August 6, 2024
Study Registration Dates
First Submitted
June 11, 2024
First Submitted That Met QC Criteria
June 11, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/01109
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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