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Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
IASTM of Gastrocnemius + Conventional therapy
IASTM of AchillesTendon + Conventional Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring plantar Fascitis, Ache, Joint Range of Motion, Disability

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both male and female Participants between age of 25 and 50 years Patients with maximal pain located at the antero-medial aspect of the plantar surface of the calcaneus Pain aggravated by passive dorsiflexion or standing/ walking on the big toe Patients with pain on taking first step in the morning(18) Patient volunteer to participate in the study and signed informed consent. Exclusion Criteria: Patient with history of musculoskeletal disorders. Patient with any previous history of ankle or foot surgery. Patient with history of ankle or foot fracture. Patient with severe bone disorder (osteoporosis) Patient with history of Venous insufficiency.

Sites / Locations

  • Adam Life CareRecruiting
  • Attock HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IASTM Gastrocnemius

IASTM Achillies Tendon

Arm Description

Instrument assisted soft tissue mobilization on gastrocnemius Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle

Instrument assisted soft tissue mobilization Achillies Tendon Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Visual analogue scale id used to measures pain intensity. It consists of a 10cm line, with two end points representing 0 ('no pain') and 10 (pain as bad as it could possibly be)

Secondary Outcome Measures

Goniometer
Goniometer is used to measure the ROM of joints
Foot and ankle disability index
Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales.

Full Information

First Posted
March 7, 2023
Last Updated
June 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05775302
Brief Title
Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis
Official Title
Effects of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
Aim of this study is to compare the effects of instrument assisted soft tissue mobilization on gastrocnemius and Achilles tendon on pain,range of motion and foot disability.A randomized control trial that will include total 32 participants and divided into two groups.Patients in Group A will receive instrument assisted soft tissue mobilization of gastrocnemius and Group B will receive instrument assisted soft tissue mobilization of Achilles tendon. While conventional therapy will be given to both groups.Data collected will be analyzed through SPSS 25.
Detailed Description
Plantar fasciitis is typical condition that produces pain in the medial longitudinal arch of the foot.Repetitive traction stresses on the plantar fascia at its origin over the distal calcaneus obesity, the makeup of the feet, and lifestyle choices are all factors that might contribute to the development of PF. Physiotherapy interventions includes stretching the gastrocnemius and soleus,dry needling, IASTM (instrument assisted soft tissue mobilisation), exercise therapy, ultrasound therapy, iontophoresis, laser therapy, splints, and taping.Use of Instrument-Assisted Soft Tissue Massage has increased in popularity, and the plantar fascia is a superficial tissue that may benefit from this treatment.The Graston Technique Instrument-assisted Soft Tissue Mobilisation not only increases blood flow and tissue healing to the area as well as breaking up soft tissue restrictions along with increase fibroblasts, mast cell production and phagocytes. Previous literature were limited in sample size, and only immediate effects of these techniques were studied But this study opted for the long term use of graston technique on gastrocnemius in comparison on Achilles tendon. So the purpose of this study is to compare the effects of Graston technique instrument assisted soft tissue mobilization at gastrocnemius and Achilles tendon in patients with planter fascitis. It will add to the growing body of knowledge that if same technique on different soft tissues will yield comparable outcomes,which should be the alternate choice of therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
plantar Fascitis, Ache, Joint Range of Motion, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IASTM Gastrocnemius
Arm Type
Experimental
Arm Description
Instrument assisted soft tissue mobilization on gastrocnemius Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle
Arm Title
IASTM Achillies Tendon
Arm Type
Active Comparator
Arm Description
Instrument assisted soft tissue mobilization Achillies Tendon Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle
Intervention Type
Other
Intervention Name(s)
IASTM of Gastrocnemius + Conventional therapy
Intervention Description
The SWEEP technique will be performed downwards from the popliteal region to the Achilles tendon for 60 seconds, 30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week.
Intervention Type
Other
Intervention Name(s)
IASTM of AchillesTendon + Conventional Therapy
Intervention Description
Participants will receive a maximum of 60 seconds<30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual analogue scale id used to measures pain intensity. It consists of a 10cm line, with two end points representing 0 ('no pain') and 10 (pain as bad as it could possibly be)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Goniometer
Description
Goniometer is used to measure the ROM of joints
Time Frame
4 weeks
Title
Foot and ankle disability index
Description
Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female Participants between age of 25 and 50 years Patients with maximal pain located at the antero-medial aspect of the plantar surface of the calcaneus Pain aggravated by passive dorsiflexion or standing/ walking on the big toe Patients with pain on taking first step in the morning(18) Patient volunteer to participate in the study and signed informed consent. Exclusion Criteria: Patient with history of musculoskeletal disorders. Patient with any previous history of ankle or foot surgery. Patient with history of ankle or foot fracture. Patient with severe bone disorder (osteoporosis) Patient with history of Venous insufficiency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madiha Ali, MSOPMT
Phone
0331-3360064
Email
madiha.ali@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madiha Ali, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adam Life Care
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madiha Ali, MSOMPT
Phone
0331-3360064
Email
madiha.ali@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Parwasha Shoukat, MSOMPT*
Facility Name
Attock Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madiha Ali, MSOMPT
Phone
0331-3360064
Email
madiha.ali@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Parwasha Shoukat, MSOMPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis

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