NCT05475899

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
completed

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

June 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 24, 2022

Last Update Submit

July 24, 2022

Conditions

Keywords

Plantar fasciitisInstrument assisted soft tissue mobilization.kinesiology taping

Outcome Measures

Primary Outcomes (1)

  • Foot function index (FFI)

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

    2nd week.

Study Arms (2)

Instrument assisted soft tissue mobilization

ACTIVE COMPARATOR

Patients 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.

Device: Instrument assisted soft tissue mobilization

kinesiology taping

EXPERIMENTAL

Patients 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.

Device: Instrument assisted soft tissue mobilization

Interventions

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

Also known as: Conventional Treatment: cold pack and Stretching exercises
Instrument assisted soft tissue mobilizationkinesiology taping

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Life care International hospital

Rawalpindi, Punjab Province, 46200, Pakistan

Location

The Health Professionals

Rawalpindi, Punjab Province, 46220, Pakistan

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 27, 2022

Study Start

June 10, 2021

Primary Completion

March 31, 2022

Study Completion

May 15, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations