NCT05775302

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 7, 2023

Last Update Submit

March 12, 2024

Conditions

Plantar Fascitis

Keywords

plantar FascitisAcheJoint Range of MotionDisability

Outcome Measures

Primary Outcomes (1)

  • 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)

    4 weeks

Secondary Outcomes (2)

  • Goniometer

    4 weeks

  • Foot and ankle disability index

    4 weeks

Study Arms (2)

IASTM Gastrocnemius

EXPERIMENTAL

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

Other: IASTM of Gastrocnemius + Conventional therapy

IASTM Achillies Tendon

ACTIVE COMPARATOR

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

Other: IASTM of AchillesTendon + Conventional Therapy

Interventions

IASTM of Gastrocnemius + Conventional therapyOTHER

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.

IASTM Gastrocnemius
IASTM of AchillesTendon + Conventional TherapyOTHER

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.

IASTM Achillies Tendon

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adam Life Care

Rawalpindi, Punjab Province, 43600, Pakistan

Location

Attock Hospital

Rawalpindi, Punjab Province, 43600, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Madiha Ali, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 20, 2023

Study Start

March 15, 2023

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)