AzTrials
AzTrials

Rheumatoid ArthritisNCT05039242

Effects of Kinesiotaping for Hands Function in Rheumatoid Arthritis

A study testing Conventional Physical Therapy), Kinesiotaping with I shaped application and Kinesiotaping with Fan-shaped Application in people with Rheumatoid Arthritis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this research is to compare the effects of I-shape and fan shape kinesiotape techniques on pain, range of motion, grip strength and ADLs of patients with Rheumatoid Arthritis. Randomized controlled trials done at Pain Clinic, Rawalpindi and Fauji Foundation Hospital, Rawalpindi. The sample size was 66. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Conventional Physical Therapy), Kinesiotaping with I shaped application and Kinesiotaping with Fan-shaped Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 sitePakistan
Study dates
15 Sep 2021to 1 Jul 2022
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Symptomatic subjects having age between 18-60 years.
  • Patients with diagnosed established Rheumatoid Arthritis of Hands (i.e greater than 6 months of onset of Rheumatoid Arthritis).
  • Patients who are currently experiencing pain in their hands.

Who cannot join

  • Patients with any malignancy, infections, open wounds, skin allergy, cellulitis, DVT or any deformities of hands.
  • Patients with co-morbidities including congestive heart failure, kidney disease, or any neurological deficits.
  • Patients with other conditions affecting hands except Rheumatoid Arthritis.
  • Patients with any history of hand surgery.
  • Patients not presenting for follow up on designated date (every 6th day)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • fouji Foundation hospital

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Effects of Kinesiotaping for Hands Function in Patients With Rheumatoid Arthritis

The aim of this research is to compare the effects of I-shape and fan shape kinesiotape techniques on pain, range of motion, grip strength and ADLs of patients with Rheumatoid Arthritis. Randomized controlled trials done at Pain Clinic, Rawalpindi and Fauji Foundation Hospital, Rawalpindi. The sample size was 66. The subjects were divided in three groups, 22 subjects in control group receiving conventional physical therapy treatment, 22 subjects in second group with I-Band application of kinesiotaping and 22 in the third group with fan-shaped application of kinesiotaping. Study duration was of 6 months. Sampling technique applied was non-probability convenience sampling. Only 25-50 years symptomatic female patients with established RA were included. Tools used in the study are Michigan Hand Outcome Questionnaire (MHQ), Numeric Pain Raiting Scale, Dynamometer and Goniometer. Data was be analyzed through SPSS 21.

Read the detailed description

Rheumatoid Arthritis is an autoimmune systemic condition characterized by joint inflammation and extra-articular erosions. The symptoms of RA usually progress with age from mild to severe. The progression can either occur insidiously over a period of months or it can occur in weeks or overnight. RA with symptoms lasting less than six months is called as "early", while with symptoms lasting longer than this is known as "established". RA has significant direct costs, such as health-care costs, as well as indirect costs, such as lost income due to morbidity and reduced life expectancy. In the urban population of southern Pakistan, Karachi, the prevalence of RA is reported to be 0.142%, whereas in northern Pakistan the estimated prevalence is 0.55%. In 2014, the overall age-adjusted prevalence of RA ranged from 0.53 to 0.55% (0.29-0.31% for males and 0.73-0.78% for females). In general, rheumatoid arthritis preferentially affects women with female to male ratio of about 3:1; however, patients with above 60 years of age have equal female to male ratio. The most prevalent age is 45-60 years. The disease severity increases with increase in the age and reaches to its peak in above 60 years of age.

The joints of hand affected by of RA include polyarthritis of small joints like proximal interphalengeal (PIP), metacarpophalengeal (MCP) joints, wrist and metatarsophalangeal (MTP) joints. Patients experience morning stiffness in these joints which lasts unto several hours. The signs on examination involves swelling, stiffness, tenderness over the affected joints, decreased range of motion and deformity like; trigger finger, boutonniere and swan neck deformity. These signs results in loss of function and mobility. Moreover, the progression of RA occurs in four stages. Stage 1 has no destructive changes on x-ray, stage 2 shows periarticular osteoporosis and subchondral bone destruction on x-ray with no joint deformity, stage 3 reveals periarticular osteoporosis with cartilage and bone destruction on x-ray and significant joint deformity and stage 4 proceeds with stage 3 with the addition of bony and fibrous ankylosis Rheumatoid arthritis is a chronic, incurable disease. All of the currently known treatments are aimed at alleviating symptoms and increasing quality of life. Treatments aim to relieve pain and decrease the progression of RA in order to prevent disability and improve functional capability . The four most common components of Physical therapy for RA hands are exercise therapy, joint protection advice and provision of functional splinting and assistive devices, massage therapy and patient education. Exercise therapy includes ROM exercises, aerobic exercise and stabilization/coordination exercises. Joint protection includes rest and splinting that uses orthosis to prevent the development of deformities and support joints. Massage therapy involves manual trigger of an articular movement focused on the improvement of function, pain reduction, reduction of disease activity improve flexibility and welfare (dimension of depression, anxiety, mood and pain). Patient education is done to inform them about their disease and the various therapies available to help them live a better life. Additional interventional strategies include application of cold therapy, heat therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and hydrotherapy exercises are also beneficial as they induce minimal loads on the joints during exercise.

In 2016 Sarah Roberts et al conducted an RCT in order to check the effects of kinesio tape on pain and metacarpophalengeal joints of hands in patients with rheumatoid arthritis, the results revealed significant reduction in pain, improvement in ROM and enhanced grip strength in work and ADLs. Another study in 2016 conducted by Vilija Zebrauskaite et al in their study about the additive effects of kinesiotape for physiotherapy of patients with rheumatoid hand to correct to ulnar positioning of hand and improve hand function. The results were significantly positive with the hand function improved considerably in comparison with the group receiving only physiotherapy exercises. In 2019 Majid Farhadian et al conducted an RCT to investigate the effects of kinesio tape on pain, range of motion, hand strength and functional abilities in patients with hand osteoarthritis. The findings of this study revealed that Kinesio taping and hand training may help patients with HOA improve their discomfort, range of motion, hand strength, and upper-extremity functional capacities. Furthermore, these two approaches can be utilised in conjunction for the treatment of this illness.

The previous studies have shown the positive effects of kinesiotape on hand functions of patients with RA. Since kinesiotape has vast variety of application techniques, and in order to determine the effectiveness of each application technique, current study is going to be conducted to compare the effects of I strip application technique and fan cut or web strip application technique.

Being tested
Conventional Physical Therapy), Kinesiotaping with I shaped application, Kinesiotaping with Fan-shaped Application
Keywords
rheumatoid arthritis, Kinesio Tape, hand strength, Metacarpophalangeal Joint
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Conventional Physical Therapy)Other

    Participants will receive a Hand exercise program including 8 different movements according to Flat 20 (flexion, extension, radial deviation of the fingers, dorsal flexion, palmar flexion, ulnar deviation of the fingers, and opposition and abduction of thumbs.

    Repetitions include 5 times during each session, as given in the study. Balanced resistive hand exercise with use of physio hand ball squeezes including finger abduction and adduction exercises with MCP extended and gross grip.

    Each contraction to be held for 3-5 seconds with a 20-second rest between contractions. Five repetitions of each resistive exercise will be done.

  • Kinesiotaping with I shaped applicationOther

    Participants will receive Kinesiotape, by using I application technique from proximal to distal on dorsum of hand and forearm with less than 50% stretch of the subjects on both hands, once a week for a total time period of 4 weeks with 4 KT applications in total (19). Kinesiotape will be worn by the subjects for 3 days. basic hand exercises will accompny it. Weekly assessments will be completed for pain, ROM, joint stiffness, grip strength and ADLs.

  • Kinesiotaping with Fan-shaped ApplicationOther

    Participants will receive exercise interventions as group A along with that the Kinesiotape will be applied, by using fan cut application technique on MCP joints involving extensor tendons of fingers on dorsal surface of both hands of subjects, once a week for a total time period of 4 weeks with 4 KT applications in total.

    Kinesiotape will be worn by the subjects for 3 days. Less than 50% stretch with space correction technique. basic hand exercises will accompny it. Weekly assessments will be completed for pain, ROM, joint stiffness, grip strength and ADLs.

Study groups in NCT05039242
Study groupRoleWhat they receive
Control Group A(Conventional Physical Therapy)Active comparatorBalanced resistive hand exercise with use of physio hand ball squeezes
Receives: Other: Conventional Physical Therapy)
Experimental Interventional Group B (I-Band Application of Kinesiotaping)ExperimentalParticipants will receive exercise interventions as group A along with that the Kinesiotape, by using I application technique from proximal to distal on dorsum of hand and forearm.
Receives: Other: Kinesiotaping with I shaped application
Experimental Interventional Group C (fan shaped Application of Kinesiotaping)ExperimentalParticipants will receive exercise interventions as group A along with that the Kinesiotape will be applied, by using fan cut application technique on MCP joints involving extensor tendons of fingers on dorsal surface of both hands of subjects
Receives: Other: Kinesiotaping with Fan-shaped Application

What is being measured

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

  1. Numeric Pain Rating Score

    The NPRS is used to measure the the pain at metacarpoplaalngeal joints. its a11- point scale with 0 showing no pain and 10 showing maximum pain

    Measured: 4th week

  2. hand strength

    hand strength is measured by dynamometer. the person grips the dynamometer and the reading shows the hand and grip strength

    Measured: 4th week

Secondary outcomes (12)
  1. metacarpoplahangeal Flexion Rt hand

    the flexion ROM will be measured by the goniometer.

    Measured: 4th week

  2. metacarpoplahangeal Extension Rt hand

    the extension ROM will be measured by the goniometer.

    Measured: 4th week

  3. metacarpoplahangeal flexion Lt hand

    the flexion ROM will be measured by the goniometer.

    Measured: 4th week

  4. metacarpoplahangeal Extension Lt hand

    theExtension ROM will be measured by the goniometer.

    Measured: 4th week

  5. wrist Extension Rt hand

    the Extension ROM will be measured by the goniometer.

    Measured: 4th week

  6. wrist Flexion Rt hand

    the Flexion ROM will be measured by the goniometer.

    Measured: 4th week

  7. ulnar deviation Rt hand

    the ulnar deviation ROM will be measured by the goniometer.

    Measured: 4th week

  8. radial deviation Rt hand

    the radial deviation ROM will be measured by the goniometer.

    Measured: 4th week

  9. wrist Extension Lt hand

    the Extension ROM will be measured by the goniometer.

    Measured: 4th week

  10. wrist Flexion Lt hand

    the Flexion ROM will be measured by the goniometer.

    Measured: 4th week

  11. ulnar deviation Lt hand

    the ulnar deviation ROM will be measured by the goniometer.

    Measured: 4th week

  12. radial deviation Lt hand

    the radial deviation ROM will be measured by the goniometer.

    Measured: 4th week

Timeline

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

  1. First posted9 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completion1 Jun 2022
  4. Study completion1 Jul 2022

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039242
Sponsor's protocol ID
REC/01071 Summyyia Ayaz
Status last verified
Aug 2022
First submitted
1 Sep 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chauhan K, Jandu JS, Goyal A, Bansal P, Al-Dhahir MA. Acute Rheumatoid Arthritis.

  • Ottawa Panel. Ottawa Panel evidence-based clinical practice guidelines for therapeutic exercises in the management of rheumatoid arthritis in adults. Phys Ther. 2004 Oct;84(10):934-72.

    PubMed 15449978
  • Alam SM, Kidwai AA, Jafri SR, Qureshi BM, Sami A, Qureshi HH, Mirza H. Epidemiology of rheumatoid arthritis in a tertiary care unit, Karachi, Pakistan. J Pak Med Assoc. 2011 Feb;61(2):123-6.

    PubMed 21375157
  • Hunter TM, Boytsov NN, Zhang X, Schroeder K, Michaud K, Araujo AB. Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004-2014. Rheumatol Int. 2017 Sep;37(9):1551-1557. doi: 10.1007/s00296-017-3726-1. Epub 2017 Apr 28.

    PubMed 28455559
  • Jalil F, Arshad M, Bhatti A, Jamal M, Ahmed M, Malik JM, Ali S, Akbar F, John P. Progression pattern of rheumatoid arthritis: A study of 500 Pakistani patients. Pak J Pharm Sci. 2017 Jul;30(4):1219-1223.

    PubMed 29039317
  • Williams MA, Williamson EM, Heine PJ, Nichols V, Glover MJ, Dritsaki M, Adams J, Dosanjh S, Underwood M, Rahman A, McConkey C, Lord J, Lamb SE. Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation. Health Technol Assess. 2015 Mar;19(19):1-222. doi: 10.3310/hta19190.

    PubMed 25748549
  • Dakkak YJ, Jansen FP, DeRuiter MC, Reijnierse M, van der Helm-van Mil AHM. Rheumatoid Arthritis and Tenosynovitis at the Metatarsophalangeal Joints: An Anatomic and MRI Study of the Forefoot Tendon Sheaths. Radiology. 2020 Apr;295(1):146-154. doi: 10.1148/radiol.2020191725. Epub 2020 Feb 11.

    PubMed 32043949
  • Walters JE, Brown AR, Jones AE. Use of the Copenhagen Burnout Inventory with social workers: a confirmatory factor analysis. Human Service Organizations: Management, Leadership & Governance. 2018;42(5):437-56.

  • Williams MA, Srikesavan C, Heine PJ, Bruce J, Brosseau L, Hoxey-Thomas N, Lamb SE. Exercise for rheumatoid arthritis of the hand. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD003832. doi: 10.1002/14651858.CD003832.pub3.

    PubMed 30063798
  • de Jong Z, Munneke M, Zwinderman AH, Kroon HM, Jansen A, Ronday KH, van Schaardenburg D, Dijkmans BA, Van den Ende CH, Breedveld FC, Vliet Vlieland TP, Hazes JM. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial. Arthritis Rheum. 2003 Sep;48(9):2415-24. doi: 10.1002/art.11216.

    PubMed 13130460

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Physical Therapy), Kinesiotaping with I shaped application and Kinesiotaping with Fan-shaped Application 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 3 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: finished, as of the sponsor's last update on 11 Aug 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Score (time frame: 4th week). The study lists 2 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 NCT05039242, which also lists 10 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 11 Aug 2022.

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