AzTrials
AzTrials

Rheumatoid ArthritisNCT06459453

Effects of Kaltenborn Versus Mulligan Techniques in Rheumatoid Arthritis.

A study testing Kaltenborn and Mulligan in people with Rheumatoid Arthritis, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Kaltenborn and Mulligan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
23 Nov 2023to 6 Aug 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 .

Trial locations and contacts

1 site in 1 country.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Imran Amjad, PhD contact

0515481826

Pakistan1 site, 1 recruiting
  • Shaikh zayed hospital

    Lahore, Punjab Province

    Hajra Anwer, 03347052438, hajiraanwer@gmail.com

    Aqsa Arshad, Ms-OMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Kaltenborn, Mulligan
Keywords
: Rheumatoid arthritis, Wrist joint , Kaltenborn, Mulligan
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • KaltenbornOther

    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.

  • MulliganOther

    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.

Study groups in NCT06459453
Study groupRoleWhat they receive
Kaltenborn TechniqueActive comparatorPer 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.
Receives: Other: Kaltenborn
Mulligan TechniqueExperimentalPer 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.
Receives: Other: Mulligan

What is being measured

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

  1. 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. .

    Measured: 4 weeks

  2. 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 .

    Measured: 4 weeks

  3. 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.

    Measured: 4weeks

Timeline

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

  1. First posted14 Jun 2024
  2. Study start23 Nov 2023
  3. Primary completion5 Jul 2024 (estimated)
  4. Study completion6 Aug 2024 (estimated)

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
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459453
Sponsor's protocol ID
REC/RCR&AHS/23/01109
Status last verified
Jun 2024
First submitted
11 Jun 2024
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15077287
  • Gavrila BI, Ciofu C, Stoica V. Biomarkers in Rheumatoid Arthritis, what is new? J Med Life. 2016 Apr-Jun;9(2):144-8.

    PubMed 27453744
  • 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.

    PubMed 33799362
  • 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.

    PubMed 11792885
  • 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.

    PubMed 37378145
  • Ilan DI, Rettig ME. Rheumatoid arthritis of the wrist. Bull Hosp Jt Dis. 2003;61(3-4):179-85.

    PubMed 15156823
  • 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.

    PubMed 29166759
  • 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.

    PubMed 37048705
  • 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.

    PubMed 16467182
  • 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.

    PubMed 23288628
  • 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.

    PubMed 20959326
  • 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.

    PubMed 25232530
  • 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.

    PubMed 7521116
  • Halverson PB. Extraarticular manifestations of rheumatoid arthritis. Orthop Nurs. 1995 Jul-Aug;14(4):47-50. doi: 10.1097/00006416-199507000-00009.

    PubMed 7659452
  • 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.

    PubMed 26321751

Questions about this trial

What is this clinical trial studying?

A study testing Kaltenborn and Mulligan in people with Rheumatoid Arthritis, run by Riphah International University at 1 site in Pakistan.

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 Pakistan. 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?

Results are not available in the source record.

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

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS(visual analogue scale) (time frame: 4 weeks). The study lists 3 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 NCT06459453, which also lists 22 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 Jun 2024.

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