NCT05039242

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

September 1, 2021

Last Update Submit

August 10, 2022

Conditions

Keywords

rheumatoid arthritisKinesio Tapehand strengthMetacarpophalangeal Joint

Outcome Measures

Primary Outcomes (2)

  • 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

    4th week

  • hand strength

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

    4th week

Secondary Outcomes (12)

  • metacarpoplahangeal Flexion Rt hand

    4th week

  • metacarpoplahangeal Extension Rt hand

    4th week

  • metacarpoplahangeal flexion Lt hand

    4th week

  • metacarpoplahangeal Extension Lt hand

    4th week

  • wrist Extension Rt hand

    4th week

  • +7 more secondary outcomes

Study Arms (3)

Control Group A(Conventional Physical Therapy)

ACTIVE COMPARATOR

Balanced resistive hand exercise with use of physio hand ball squeezes

Other: Conventional Physical Therapy)

Experimental Interventional Group B (I-Band Application of Kinesiotaping)

EXPERIMENTAL

Participants 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.

Other: Kinesiotaping with I shaped application

Experimental Interventional Group C (fan shaped Application of Kinesiotaping)

EXPERIMENTAL

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

Other: Kinesiotaping with Fan-shaped Application

Interventions

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.

Control Group A(Conventional Physical Therapy)

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.

Experimental Interventional Group B (I-Band Application of Kinesiotaping)

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.

Experimental Interventional Group C (fan shaped Application of Kinesiotaping)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

fouji Foundation hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (10)

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

    BACKGROUND
  • 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.

    PMID: 15449978BACKGROUND
  • 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.

    PMID: 21375157BACKGROUND
  • 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.

    PMID: 28455559BACKGROUND
  • 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.

    PMID: 29039317BACKGROUND
  • 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.

    PMID: 25748549BACKGROUND
  • 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.

    PMID: 32043949BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30063798BACKGROUND
  • 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.

    PMID: 13130460BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Aisha Razzaq, MSPT-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 9, 2021

Study Start

September 15, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations