Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05475899 |
| Other study ID # |
REC/01048 Sidra Tariq |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2021 |
| Est. completion date |
May 15, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Riphah International University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of this study is to compare the effects of Instrument Assisted soft tissue
mobilization and kinesiology taping on the pain, disability and range of motion of the
patients and to compare the cost-effectiveness of both these treatment approaches. RCT done
at health professionals, Life Care International hospital, and railway general hospital. The
sample size was 36. Patients diagnosed with plantar fasciitis were randomized into 2 groups
i.e., Group A and Group B with the help of non-probability convenience sampling. Both groups
had received conventional Physiotherapy interventions (Stretching, Manual therapy, exercise
therapy and home exercise plane.) along with specific techniques. The patients in group A had
received Instrument assisted soft tissue mobilization (IASTM) and patients in group B had
received treatment with kinesiology taping. The total duration of study was about 4 weeks.
The patients had received 3 sessions per week for a period of 4 weeks and the outcomes were
evaluated at baseline (first session), second assessment at the end of 2nd week and 3rd
assessment at the end of 4th week. Only obese patients aged between 25-65 years were included
in the study and were assessed upon the scoring of foot function index. Data will be analysed
with the help of SPSS version 21.
Description:
Plantar fasciitis is a common overuse injury that occurs as a result of repetitive traction
forces on the plantar fascia at its origin over the distal calcaneus. Patients will complain
of plantar heel pain, which is sharp rather than dull & exacerbated with the first step after
a period of non-weight-bearing, typically in the morning. Plantar fasciitis is characterized
by classic signs of inflammation including pain, swelling and loss of function but some
presentations of plantar fasciitis may be a non-inflammatory. Pain is usually worse when
barefoot on hard surfaces and with stair climbing. Pain relievers with walking initially & by
stretching of longitudinal arch because Achilles' tendon is tight & dorsiflexion is limited.
The average plantar heel pain episode lasts longer than 6 months and it affects up to 10-15 %
of the population. However, approximately 90 % of cases are treated successfully with
conservative care. It is estimated that 1 in 10 people will develop PF during their lifetime.
PF, which is more common in middle-aged obese females and young male athletes, has a higher
incidence in the athletic population though not all suffering requires medical treatment. It
is thought to occur in about 10 % of the general population as well, with 83 % of these
patients being active working adults between the ages of 25 and 65 years old. Plantar
fasciitis is diagnosed on the basis of medical history and physical examination including
inspection and palpation to check for inflammation and tenderness.
Plantar fasciitis is defined as a localized inflammation & degeneration of planter fascia (a
thick, broad, inelastic band of fibrous tissue on the plantar surface). The most widely
accepted diagnostic test for plantar fasciitis is windlass test. It is performed by passively
dorsiflexing the big toe of the involved foot in either weight bearing or non-weight bearing
condition. Test will be positive when patient feels pain on the plantar surface while
dorsiflexing the big toe. Treatments of plantar fasciitis include pharmacological therapy
[medications (oral analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs)
, injections (local anesthetics, steroids, botulinum toxin A, and/or saline)] Physiotherapy
(Gastrocnemius-soleus stretching , dry needling, IASTM (instrument assisted soft tissue
mobilization), extracorporeal shock wave therapy, exercise therapy, ultrasound therapy,
iontophoresis, laser therapy, splints and kinesiology taping), and Surgery (fasciotomy,
cryosurgery) Taping is beneficial technique for planter fasciitis in short term treatment &
can be implemented as an immediate pain reliever. It helps in pain reduction, joint support,
proprioception & muscle tone normalization. It has immediate positive effect on pain &
function. The use of kinesiology taping results in better functional performance & balance.
It has reduced pain in patients who use it as a short-term treatment. One intervention
growing in popularity is Kinesio Tape and is marketed to be an easy-to-use, easily
accessible, and cost-effective treatment option. Several theories have been proposed to
describe its effect. The most widely-accepted theory states that the tape simulates the
elasticity of skin and serves to pull the outer layer of skin off the underlying muscle and
soft tissue structures, improving muscle function and decrease pressure on soft tissues, and
create a larger space and channel for enhanced lymph flow . Another study in 2018 to check
the effectiveness of kinesiology tape in plantar fasciitis. The study was an experimental
study. Forty subjects were randomly allocated into two groups - Taping and control groups.
The taping group (KT group) consisted of 20 subjects and intervened with the application of
kinesiology tape (K tape). The control group consisted of 20 subjects and plantar fascia and
calf stretching exercises were given during the treatment period. The results showed that the
experimental group had a significant improvement in functional performance and dynamic
balance when compared to the control group. Both male and female subjects in the age group of
40 to 60 years, subjects presenting with the symptoms of plantar fasciitis for more than 6
months were included. I have selected kinesiology taping for my study because I want to
explore about it effects on subacute and chronic patients and to compare its cost
effectiveness with other treatments available for this condition.
Instrument assisted soft tissue mobilization is a popular treatment for myofascial
restriction. IASTM uses specially designed instruments to provide a mobilizing effect to scar
tissue and myofascial adhesions. Several IASTM tools and techniques are available such as the
GRASTON ® technique. A study was conducted to determine the effectiveness of GRASTON
Technique® for decreasing pain and increasing function in participants with chronic plantar
heel pain over a six-week period. A single blind, was conducted with a sample of 22 adults (5
males, 17 females). Participants were assigned to three groups: GT/stretching,
effleurage/stretching, and stretching only. Participants improved in variables measured over
a six-week treatment of GT. I have selected GRASTON technique in comparison with kinesiology
taping in order to check which is most effective in terms of cost and treatment approach and
to see in how many sessions patients with subacute and chronic plantar fasciitis will get
results.
