NCT06686706

Brief Summary

The Objective of the study is to compare the effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio taping for improving foot functional status and Quality of Life (QOL) in patients with Plantar Fasciitis. The study will be randomized controlled Trial including 2 experimental groups and 19 participants in each group

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Plantar FascitisIASTMGraston techniqueKinesio Taping

Outcome Measures

Primary Outcomes (2)

  • Foot and Ankle Outcome Score (FAOS):

    FAOS is a 42-item questionnaire divided into 5 subscales pain (9 items), other symptoms (7 items), ADL (17 items), sport/recreation (5 items) and quality of life (4 items). A five-point Likert scale, with 0 denoting no problem, 1 mild, 2 moderate, 3 severe, and 4 extreme problems, is used to grade each item. Each subscale's total score is summed together and divided by the subscale's maximum score, to determine the score for each subscale. A scale of 0 to 100 is created from the normalized score, where 100 represents no problems and 0 represents severe problems.

    4 weeks

  • SF-12

    A short health survey-12 version 2 is used to measure quality of life (SF-12 V.2). The patients' overall health and quality of life will be assessed using this questionnaire. There are twelve questions on the assessment form, and the answers can be used to score eight different areas of health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'. There are two categories on the SF-12 V.2 surveys: Mental and Physical health. Cronbach's alpha values, which ranged from 0.60 to 0.87, supported the dependability and internal consistency.

    4 weeks

Study Arms (2)

IASTM Group

EXPERIMENTAL

Instrumental Assisted Soft Tissue Mobilization

Other: IASTM

KT Group

EXPERIMENTAL

Kinesiotaping

Other: KT group

Interventions

IASTMOTHER

Graston therapy-8 min per session Procedure: The patient will be lying down with their knee bent 30 degrees. After a 5-minute ultrasound treatment and static stretching exercises.Treatment will be administered using the Graston tool (using the sweep approach). Applying a moderate amount of effort from the medial side of the heel to the metatarsals and from the metatarsals to the medial side of the heel, to-and-fro stroking at a 60° angle will be done on the sole of the foot for approximately eight minutes (60-70 strokes per minute with a 5- to 10-second rest interval. A cold pack will be used for five minutes after therapy. The GT session will last approximately 30 minutes. Conventional Therapy: Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min Functional status and Quality of Life (QOL) will be assessed before and after treatment of 4 weeks using using tools. Intervention will be conducted once a week for 4 weeks.

IASTM Group

Kinesio tapping (left there for 3 days) Procedure: We will use a standard 2" (5 cm) kinesiology tape. Fascia tape will be applied to the plantar fascia, and it will be left there for three days. For four weeks, it will be applied once a week. The patient will be in a prone position, lying with the ankle joints in a neutral position while applying tape. With the toes extended against the bed or ground. The tape will be marked on the Achilles tendon. It will be cut longitudinally into five slices of equal width. It will be applied to the forefoot by stretching it by 25%. The last strap will be applied with gentle compression across the bases of the five slices beneath the foot and wrapped around the rear foot.(5) Conventional Therapy Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min

KT Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age Range of 20-40 years
  • Standing \> 8 hours a day
  • Positive Windlass test
  • Patients who experience pain on medial tuberosity of the calcaneus on palpation.
  • Pain during the initial steps that lessened after a few steps but aggravated by increased activity

You may not qualify if:

  • History of ankle or foot surgery
  • Patients with inflammatory conditions like cancer, rheumatoid arthritis, ankle and foot bursitis.
  • Foot related complications after fracture
  • Patients receiving corticosteroid injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria Active

Rawalpindi, Punjab Province, 46300, Pakistan

RECRUITING

Related Publications (1)

  • Zhang J, Nie D, Rocha JL, Hogan MV, Wang JH. Characterization of the structure, cells, and cellular mechanobiological response of human plantar fascia. J Tissue Eng. 2018 Oct 3;9:2041731418801103. doi: 10.1177/2041731418801103. eCollection 2018 Jan-Dec.

    PMID: 30302189BACKGROUND

Study Officials

  • Shumaila Parveen, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Amman Ullah Nazir, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 13, 2024

Study Start

May 1, 2024

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations