NCT05256433

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 4, 2022

Last Update Submit

February 24, 2022

Conditions

Keywords

Musculoskeletal PainMyofascial ReleasePlantar Fasciitis

Outcome Measures

Primary Outcomes (6)

  • NPRS

    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

    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

    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

    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

    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

    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

Study Arms (2)

IASTM

EXPERIMENTAL
Other: Group-A

Transverse friction massage

ACTIVE COMPARATOR
Other: Group-B

Interventions

Group-AOTHER

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.

IASTM
Group-BOTHER

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.

Transverse friction massage

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javeria Mirza

Karachi, 75290, Pakistan

RECRUITING

MeSH Terms

Conditions

Musculoskeletal PainFasciitis, Plantar

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFasciitisFoot Diseases

Central Study Contacts

javeria mirza, BSPT,D.DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hafiza Javeria Mirza

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 25, 2022

Study Start

August 1, 2021

Primary Completion

March 31, 2022

Study Completion

August 1, 2022

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations