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Clinical Trials/CTRI/2024/10/075878
CTRI/2024/10/075878Not yet recruitingPhase 3

To Compare The Effectiveness of IASTM (Instrument Assisted Soft Tissue Mobilization)along with Conventional Physiotherapy Versus Stretching along with Conventional Physiotherapy on Pain,Function and Activities Of Daily Living in Plantar Fasciitis Patients: A Comparative study.

Priyanka Jadon1 site in 1 country40 target enrollmentStarted: November 10, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Foot and Ankle Ability Measure - Activities of Daily Living Subscale

Study Overview

Brief Summary

40 participants will be randomly divided into two groups. In Group A: All 20 patients will be treated with Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy and in Group B: All 20 patients will be treated with stretching along with conventional physiotherapy. All participants will be assessed for plantar fasciitis pain, function and activities of daily living with  a Visual Analogue Scale (VAS) , Foot Function Index Pain Subscale (FFI) and the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale  . The study will be of 2 weeks. 6 sessions will be taken in a week for both the groups. All variables will be measured at baseline, at the end of 1st week and at the end of 2nd week of the study.

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Group A (Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy)

The patient will do 5-minute warm-up exercise to warm-up the tissues(Prior to IASTM ).Each participant will then receive 2 minutes of IASTM (Instrument assisted soft tissue mobilization) over each area of restriction using Edge mobility tool after scanning the area. Cream/lubricant will be applied on calf and plantar region of foot as it will assist in reducing friction on skin and then the Edge mobility tool will be used in mobilizing the tissues on triceps surae (gastrocnemius and soleus) and plantar region of foot by pressing the tool along the leg and the foot. Ice will be offered after each session for pain management (as needed) .

Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.

The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each.

Group B (Stretching along with conventional physiotherapy)

Gastrocnemius muscle stretch: 3 repetitions for 30 sec hold

The patient will lie prone with the feet extended off at the end of the examination table so that the knee remains straight as the examiner applies firm pressure to the ball of the foot to take up slack while dorsiflexing the foot at the ankle.

Soleus muscle stretch: 3 repetitions for 30 sec hold

The patient will lie prone with the knee flexed and the ankle passively dorsiflexed. Increased pressure is gradually applied to dorsiflex the foot fully.

The stretching for each muscle gastrocnemius and soleus will be held with moderate pressure to feel stretch pressure without causing any stretch pain.

Plantar Fascia Stretch: 3 repetitions for 30 sec hold

Position of the subject will be sitting with affected leg cross over the contralateral leg .Technique is while using the hand on the affected side, the fingers will be placed across the base of the toes on the bottom of the foot and pull the toes back toward the shin until they feel a stretch in the arch of the foot. This will confirm that the stretching is correct by palpating the tension in the plantar fascia with the contralateral hand while performing the stretching.

Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.

The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Males and females between age group 30-50 years, Subjects having pain for more than 3 months over the heel, Pain with first steps upon walking (greater than or equal to 3 on a 0 to 10 VAS scale), Pain that is worse in the morning during the initial steps, but which decreases after walking continues.

Exclusion Criteria

  • Persons who are undergoing corticosteroids injection, receiving plantar non- steroidal anti- inflammatory medications within the previous 3 week, Any known radiating pain (lower limb), Any other lower extremity injury during the previous 6 months, Currently engaging in any Physical therapy within previous 1 week , Calcaneal fracture.

Outcomes

Primary Outcomes

Foot and Ankle Ability Measure - Activities of Daily Living Subscale

Time Frame: 2 weeks

Foot Function Index - Pain Subscale

Time Frame: 2 weeks

Visual analogue scale

Time Frame: 2 weeks

Secondary Outcomes

  • Visual Analogue Scale (VAS)(1 week)

Investigators

Sponsor
Priyanka Jadon
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Priyanka Jadon

Mahatma Gandhi University of Medical Sciences and Technology

Study Sites (1)

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