Clinical trial NCT05039242: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Kinesio Tape
hand strength
Metacarpophalangeal Joint
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Numeric Pain Rating Score
timeFrame: 4th week
measure: hand strength
timeFrame: 4th week
Secondary outcomes:
measure: metacarpoplahangeal Flexion Rt hand
timeFrame: 4th week
measure: metacarpoplahangeal Extension Rt hand
timeFrame: 4th week
measure: metacarpoplahangeal flexion Lt hand
timeFrame: 4th week
measure: metacarpoplahangeal Extension Lt hand
timeFrame: 4th week
measure: wrist Extension Rt hand
timeFrame: 4th week
measure: wrist Flexion Rt hand
timeFrame: 4th week
measure: ulnar deviation Rt hand
timeFrame: 4th week
measure: radial deviation Rt hand
timeFrame: 4th week
measure: wrist Extension Lt hand
timeFrame: 4th week
measure: wrist Flexion Lt hand
timeFrame: 4th week
measure: ulnar deviation Lt hand
timeFrame: 4th week
measure: radial deviation Lt hand
timeFrame: 4th week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: fouji Foundation hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aisha Razzaq, MSPT-OMPT
role: PRINCIPAL_INVESTIGATOR
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