AzTrials
AzTrials

Plantar FascitisNCT05475899

Comparison of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Plantar Fasciitis

A study testing Instrument assisted soft tissue mobilization in people with Plantar Fascitis, run by Riphah International University at 2 sites in Pakistan.

Completed

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

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Plantar Fascitis
What is being tested?
Instrument assisted soft tissue mobilization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesPakistan
Study dates
10 Jun 2021to 15 May 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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants falling in this category will be recruited into the study.
  • Patients with subacute and chronic plantar fasciitis.
  • Positive windlass test (Aggravation of pain with passive dorsiflexion of big toe, during walking and standing on toes). Patients with a minimum FFI (pain and disability) rating score of 4. Pain worse on the first few steps in the morning.
  • Both males and females
  • Obese patients.
  • Active working adults between the ages of 25 and 65 years old
  • Patients who agreed not to wear high heeled shoes during study.

Who cannot join

  • Patients having any other medical condition or trauma
  • Patients sensitive to any of the above mentioned treatment modalities.

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Life care International hospital

    Rawalpindi, Punjab Province, 46200

  • The Health Professionals

    Rawalpindi, Punjab Province, 46220

Other trials in Pakistan

About this study

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.

Read the detailed 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.

Being tested
Instrument assisted soft tissue mobilization
Keywords
Plantar fasciitis, Instrument assisted soft tissue mobilization., kinesiology taping
Medical subject headings
Fasciitis, Plantar

What participants receive

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

  • Instrument assisted soft tissue mobilizationDevice

    Also called Conventional Treatment: cold pack and Stretching exercises

    Application of IASTM on the plantar fascia with 10-15 strokes followed by stretching

Study groups in NCT05475899
Study groupRoleWhat they receive
Instrument assisted soft tissue mobilizationActive comparatorPatients in group A will be treated with the help of Instrument Assisted soft tissue mobilization GRASTON technique along with the conventional treatment. • Patient will be prone position with the foot over the edge of the table. Instrument will be applied from downward to upward direction with maximum of 10 - 15 strokes per session. These strokes will be applied in two sets of 10 strokes followed by stretches after each set. Conventional treatment includes icing and stretching of the calf muscles. Icing will be done for the total of 3-5 minutes. Both groups will be given session of 40 min/day, 3 days/week for 4 weeks, assessment will be done at baseline, at the end of 2nd week \& at the end of 4th week.
Receives: Device: Instrument assisted soft tissue mobilization
kinesiology tapingExperimentalPatients in group B will be treated with the help of kinesiology taping along with the conventional treatment. Patient will be in prone position with the dorsiflexion of the foot supported on the bed. Fan shaped taping will be applied with 60 - 100 % tension in the centre of the tape. The ends of the tape; the anchor will be applied without any stretch while centre of the tape will be stretched to approximately 60 - 100 %. Length of the tape may vary from person to person depending upon the size of the foot. Patient will be instructed to keep the tape till the next session. Conventional treatment includes icing and stretching of the calf muscles. Icing will be done for the total of 3-5 minutes. Both groups will be given session of 40 min/day, 3 days/week for 4 weeks, assessment will be done at baseline, at the end of 2nd week \& at the end of 4th week.
Receives: Device: Instrument assisted soft tissue mobilization

What is being measured

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

  1. Foot function index (FFI)

    It is a 23 scale measure instrument which is divided into 3 categories of pain, disability and activity limitation.

    Measured: 2nd week.

Timeline

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

  1. First posted27 Jul 2022
  2. Study start10 Jun 2021
  3. Primary completion31 Mar 2022
  4. Study completion15 May 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
Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475899
Sponsor's protocol ID
REC/01048 Sidra Tariq
Status last verified
Jul 2022
First submitted
24 Jul 2022
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Instrument assisted soft tissue mobilization in people with Plantar Fascitis, run by Riphah International University at 2 sites 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 7 inclusion and 2 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Foot function index (FFI) (time frame: 2nd week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jul 2022.

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