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Effects of Kinesiotaping for Hands Function in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical Therapy)
Kinesiotaping with I shaped application
Kinesiotaping with Fan-shaped Application
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, Kinesio Tape, hand strength, Metacarpophalangeal Joint

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • fouji Foundation hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group A(Conventional Physical Therapy)

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

Experimental Interventional Group C (fan shaped Application of Kinesiotaping)

Arm Description

Balanced resistive hand exercise with use of physio hand ball squeezes

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

metacarpoplahangeal Flexion Rt hand
the flexion ROM will be measured by the goniometer.
metacarpoplahangeal Extension Rt hand
the extension ROM will be measured by the goniometer.
metacarpoplahangeal flexion Lt hand
the flexion ROM will be measured by the goniometer.
metacarpoplahangeal Extension Lt hand
theExtension ROM will be measured by the goniometer.
wrist Extension Rt hand
the Extension ROM will be measured by the goniometer.
wrist Flexion Rt hand
the Flexion ROM will be measured by the goniometer.
ulnar deviation Rt hand
the ulnar deviation ROM will be measured by the goniometer.
radial deviation Rt hand
the radial deviation ROM will be measured by the goniometer.
wrist Extension Lt hand
the Extension ROM will be measured by the goniometer.
wrist Flexion Lt hand
the Flexion ROM will be measured by the goniometer.
ulnar deviation Lt hand
the ulnar deviation ROM will be measured by the goniometer.
radial deviation Lt hand
the radial deviation ROM will be measured by the goniometer.

Full Information

First Posted
September 1, 2021
Last Updated
August 10, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05039242
Brief Title
Effects of Kinesiotaping for Hands Function in Rheumatoid Arthritis
Official Title
Effects of Kinesiotaping for Hands Function in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, Kinesio Tape, hand strength, Metacarpophalangeal Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group A(Conventional Physical Therapy)
Arm Type
Active Comparator
Arm Description
Balanced resistive hand exercise with use of physio hand ball squeezes
Arm Title
Experimental Interventional Group B (I-Band Application of Kinesiotaping)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Interventional Group C (fan shaped Application of Kinesiotaping)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping with I shaped application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping with Fan-shaped Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Score
Description
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
Time Frame
4th week
Title
hand strength
Description
hand strength is measured by dynamometer. the person grips the dynamometer and the reading shows the hand and grip strength
Time Frame
4th week
Secondary Outcome Measure Information:
Title
metacarpoplahangeal Flexion Rt hand
Description
the flexion ROM will be measured by the goniometer.
Time Frame
4th week
Title
metacarpoplahangeal Extension Rt hand
Description
the extension ROM will be measured by the goniometer.
Time Frame
4th week
Title
metacarpoplahangeal flexion Lt hand
Description
the flexion ROM will be measured by the goniometer.
Time Frame
4th week
Title
metacarpoplahangeal Extension Lt hand
Description
theExtension ROM will be measured by the goniometer.
Time Frame
4th week
Title
wrist Extension Rt hand
Description
the Extension ROM will be measured by the goniometer.
Time Frame
4th week
Title
wrist Flexion Rt hand
Description
the Flexion ROM will be measured by the goniometer.
Time Frame
4th week
Title
ulnar deviation Rt hand
Description
the ulnar deviation ROM will be measured by the goniometer.
Time Frame
4th week
Title
radial deviation Rt hand
Description
the radial deviation ROM will be measured by the goniometer.
Time Frame
4th week
Title
wrist Extension Lt hand
Description
the Extension ROM will be measured by the goniometer.
Time Frame
4th week
Title
wrist Flexion Lt hand
Description
the Flexion ROM will be measured by the goniometer.
Time Frame
4th week
Title
ulnar deviation Lt hand
Description
the ulnar deviation ROM will be measured by the goniometer.
Time Frame
4th week
Title
radial deviation Lt hand
Description
the radial deviation ROM will be measured by the goniometer.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
fouji Foundation hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21375157
Citation
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.
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Effects of Kinesiotaping for Hands Function in Rheumatoid Arthritis

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