Role of Soft Tissue Therapy in Plantar Fasciitis

February 24, 2022 updated by: Hafiza Javeria, Ziauddin University

Effectiveness of Instrument Assisted Soft Tissue Mobilization (IASTM) And Manual Massage On Thickness, Pain and Foot Function Among Patient With Plantar Fasciitis

Plantar Fasciitis (PF) is a frequently and commonly reported heel pain present in every age with multifactorial etiology. It is the most common reason for constant heel pain in adults affecting both young active and older sedentary individuals. PF is reported approx. 11%-15% of all foot symptoms demanding professional care among adults. Instrument-Assisted Soft Tissue Massage (IASTM) refers to a technique that utilizes instruments to eliminate scar tissues and work with mending measure through development of new extracellular lattice proteins like collagen that may be effective in providing immediate and quick pain relief by covering a larger area. On the other hand, numerous options with conservative measures has been frequently documented in treating plantar fasciitis that may include stretching, massage, orthosis, anti-inflammatory agents and surgery etc. Although, transverse friction massage has been considered to be one of the best treatment option in reducing pain, releasing tight areas and promoting flexibility. Besides, several studies reported the usefulness of potential assessment tools for remote monitoring of patients that can be utilized by clinicians for wider range of purposes. To the best of author's knowledge, limited studies has been conducted till date utilizing the IASTM technique in comparison to conservative treatment options with standardized assessments in treating PF. Therefore, this study aims to investigate the effectiveness of IASTM to assess thickness, pain, and foot function by using ultrasound for the management of plantar fasciitis patients. The findings of this study may be useful to establish an effective treatment protocol to enhance the quality of life of the target population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Pakistan
      • Karachi, Pakistan, 75290
        • Recruiting
        • Javeria Mirza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Pre-diagnosed adults (18-55 years) with plantar fasciitis of both genders.

Exclusion Criteria:

  • Pathological bone spurs of the calcaneus
  • Burn scars
  • Polyneuropathies
  • Corticosteroid injections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IASTM
Other: Group-A
IASTM Certified IASTM practitioner will be performing the technique with emollient lubricant in which brushing and sweeping stroke will be applied for plantar fascia and fanning and sweeping stroke technique for calf muscles for the duration of 10 minutes to eliminate the inflammation. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury. The frequency stretching will be 5 repetitions for each with 10 seconds hold.
Active Comparator: Transverse friction massage
Other: Group-B
Manual massage includes transverse friction massage for plantar fascia, flexor digitorum brevis, and deep massage for calf muscle for the duration of 10 minutes to eliminate the tightness and increase the blood flow. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NPRS
Time Frame: Baseline
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Baseline
NPRS
Time Frame: 4 weeks
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
4 weeks
FAAM
Time Frame: Baseline
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Baseline
FAAM
Time Frame: 4 weeks
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
4 weeks
Diagnostic Ultrasound
Time Frame: Baseline
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
Baseline
Diagnostic Ultrasound
Time Frame: 4 weeks
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ziauddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ziauddin University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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