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Role of Soft Tissue Therapy in Plantar Fasciitis

Primary Purpose

INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group-A
Group-B
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION focused on measuring Musculoskeletal Pain, Myofascial Release, Plantar Fasciitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Javeria MirzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IASTM

Transverse friction massage

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
February 24, 2022
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05256433
Brief Title
Role of Soft Tissue Therapy in Plantar Fasciitis
Official Title
Effectiveness of Instrument Assisted Soft Tissue Mobilization (IASTM) And Manual Massage On Thickness, Pain and Foot Function Among Patient With Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION
Keywords
Musculoskeletal Pain, Myofascial Release, Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-Blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IASTM
Arm Type
Experimental
Arm Title
Transverse friction massage
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Group-A
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group-B
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS
Description
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).
Time Frame
Baseline
Title
NPRS
Description
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).
Time Frame
4 weeks
Title
FAAM
Description
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.
Time Frame
Baseline
Title
FAAM
Description
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.
Time Frame
4 weeks
Title
Diagnostic Ultrasound
Description
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.
Time Frame
Baseline
Title
Diagnostic Ultrasound
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
javeria mirza, BSPT,D.DPT
Phone
03023314129
Email
javeria.mirza@zu.edu.pk
Facility Information:
Facility Name
Javeria Mirza
City
Karachi
ZIP/Postal Code
75290
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ucksy Mallick, M.B.Bs,F.C.P.S-1
Phone
(021) 34822261
Email
umallick@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Soft Tissue Therapy in Plantar Fasciitis

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