Effects of Kaltenborn Versus Mulligan Techniques in Rheumatoid Arthritis.

NCT06459453 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/01109
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

: Rheumatoid arthritis, Wrist joint , Kaltenborn, Mulligan

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Kaltenborn Technique

ACTIVE COMPARATOR

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.

Other: Kaltenborn

Mulligan Technique

EXPERIMENTAL

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.

Other: Mulligan

Interventions

Kaltenborn OTHER

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.

Kaltenborn Technique

Mulligan OTHER

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.

Mulligan Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Shaikh zayed hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (22)

• 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.

  PMID: 15077287 BACKGROUND

• Gavrila BI, Ciofu C, Stoica V. Biomarkers in Rheumatoid Arthritis, what is new? J Med Life. 2016 Apr-Jun;9(2):144-8.

  PMID: 27453744 BACKGROUND

• 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.

  PMID: 33799362 BACKGROUND

• 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.

  PMID: 11792885 BACKGROUND

• 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.

  PMID: 37378145 BACKGROUND

• Ilan DI, Rettig ME. Rheumatoid arthritis of the wrist. Bull Hosp Jt Dis. 2003;61(3-4):179-85.

  PMID: 15156823 BACKGROUND

• 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.

  PMID: 29166759 BACKGROUND

• 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.

  PMID: 37048705 BACKGROUND

• 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.

  PMID: 16467182 BACKGROUND

• 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.

  PMID: 23288628 BACKGROUND

• 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.

  PMID: 20959326 BACKGROUND

• 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.

  PMID: 25232530 BACKGROUND

• 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.

  PMID: 7521116 BACKGROUND

• Halverson PB. Extraarticular manifestations of rheumatoid arthritis. Orthop Nurs. 1995 Jul-Aug;14(4):47-50. doi: 10.1097/00006416-199507000-00009.

  PMID: 7659452 BACKGROUND

• 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.

  PMID: 26321751 BACKGROUND

• 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.

  PMID: 33269077 BACKGROUND

• 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.

  PMID: 22051110 BACKGROUND

• 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.

  PMID: 33921207 BACKGROUND

• 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.

  PMID: 3358796 BACKGROUND

• 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.

  PMID: 38037132 BACKGROUND

• 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.

  PMID: 28974987 BACKGROUND

• 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.

  PMID: 13498603 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hajra Anwer

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, PhD

CONTACT

0515481826

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding refers to a practice where study participants are prevented from knowing certain information that may somehow influence them thereby tainting the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of the treatment arms at the begining of the trial and continue in that arm throughout the length of the trial.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: November 23, 2023
• Primary Completion: July 5, 2024
• Study Completion: August 6, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

PA (1)