NCT06142123

Brief Summary

Planter fasciitis is a common cause of heel pain in adults. Planter fasciitis is frequently seen among athletes playing various sports. However, it is more prevalent in professional runner. The Biomechanical stresses including the increase in the intensity, frequency or the time frame of weight bearing activities that subject athlete's feet to continuous impact loads, surfaces with inadequate cushioning or improper shoe replacement are some of extrinsic risk factors associated with planter fasciitis.3-D ankle mobility exercises are improvised for treatment of plantar fasciitis, these comprise D2 diagonal PNF leg patterns, comprising of flexion-abduction-internal rotation and extension-adduction-external rotation. Heel drop exercise training is another useful intervention used for treating PF; the protocol consists transferring their body weight onto the forefoot of their dominant legs while slightly flexing their ankles. To get back to baseline, the non-dominant leg is given more weight, and the dominant leg's knee was remained fully extended to maintain higher gastrocnemius activation. A Randomized clinical trial will be conducted at Pakistan Sports Board and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on patients which will be allocated through opaque sealed enveloped into Group A and Group B. Group A will be treated with 3-D ankle mobility exercises and Group B will be treated with eccentric heel drop training. Outcome measures tools will be conducted through NPRS, Foot and Ankle Ability Measure (FAAM) and The VISA-A questionnaire: An index of the severity of Achilles tendinopathy after four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

Eccentric heel drop training, 3-D ankle mobility

Outcome Measures

Primary Outcomes (2)

  • Foot and Ankle Ability Measure (FAAM)

    The Foot and Ankle Ability Measures Scale is a collection of self-administered questionnaire comprising 29 questions that is split down into two subscales: activities of daily living (21 questions) and sports population (8 questions)(15). With an ICC value of 0.89 for Activities of Daily Living (ADL) and 0.87 for the Sports subscale, it has a significant level of reliability

    pre and 4 weeks post interventional

  • Numeric Pain Rating Scale

    Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"

    pre and 4 weeks post interventional

Secondary Outcomes (1)

  • The VISA-A questionnaire: An index of the severity of Achilles tendinopathy: The VISA-A questionnaire: An index of the severity of Achilles tendinopathy

    pre and 4 weeks post interventional

Study Arms (2)

Group A

EXPERIMENTAL

Group A will be treated with 3-D Ankle Mobility Exercises with combined isotonic (agonist) technique at ankle joint. Two diagonal (D2) Flexion-Extension patterns from the PNF leg patterns will be used. Both the techniques will be first performed in prone lying against the resistance of the therapist and then in crook lying. The patients will receive Intervention consisting 14 sets (7 sets for each 3-D extension-flexion \[1 set (1 min) = exercise 30sec + rest 30 sec\]) performed for 15 minutes thrice per week for four weeks

Other: 3-D Ankle Mobility Exercises(A)

Group B

EXPERIMENTAL

Group B will be treated with Eccentric Heel Drop Training and Conventional physiotherapy treatment All patients will be treated once daily with 10 sets of 15 repetitions with a frequency of 2sec per repetitions and an interval of 30 sec between each set of Eccentric Heel drop training, 4 days a week for four weeks

Other: Eccentric Heel Drop Training(B)

Interventions

The techniques will be first performed in prone lying against the resistance of the therapist and then in crook lying. 1. The participant will perform the D2 extension pattern (Planter-flexion-supination inversion-toe flexion) using the CI technique in the prone position according to the resistance of therapist. 2. The participant will perform the D2 flexion pattern (Dorsi-flexion-pronation eversion-toe extension) using CI technique in the prone position according to the resistance of therapist. 3. The participant will perform the D2 extension pattern (Planter-flexion-supination inversion-toe flexion) using the CI technique in the crook-lying position according to the resistance of therapist. 4. The participant will perform the D2 flexion pattern (Dorsi-flexion-pronation eversion-toe extension) using CI technique in the crook-lying position according to the resistance of therapist.

Group A

: Group B will be treated with Eccentric Heel Drop Training. It will comprise of following exercises (14). 1. Eccentric loading exercises of calf muscles. 2. Conventional physiotherapy treatment including Ultrasound Plantar fascia stretching Calf muscle stretching Intrinsic muscles strengthening

Group B

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale athletes
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis based on the clinical presentation Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur Pain reporting of minimum of 2 on NPRS Athletes with 18 years to 35 years of age Chronic plantar fasciitis of more than 3 months. Female athletes playing more than 2 years in sports including runners, Soccer players, cricket players, cyclist, body builders.

You may not qualify if:

  • Chronic pain syndrome or other foot pains Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radio graphically Pregnant females Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation Existing or prior osteomyelitis of the involved calcaneus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Physiotherapy Clinic

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

  • Trojian T, Tucker AK. Plantar Fasciitis. Am Fam Physician. 2019 Jun 15;99(12):744-750.

    PMID: 31194492BACKGROUND
  • Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.

    PMID: 28717618BACKGROUND
  • Alonso-Fernandez D, Taboada-Iglesias Y, Garcia-Remeseiro T, Gutierrez-Sanchez A. Effects of the Functional Heel Drop Exercise on the Muscle Architecture of the Gastrocnemius. J Sport Rehabil. 2020 Nov 1;29(8):1053-1059. doi: 10.1123/jsr.2019-0150. Epub 2019 Dec 6.

    PMID: 31810057BACKGROUND
  • Konrad A, Gad M, Tilp M. Effect of PNF stretching training on the properties of human muscle and tendon structures. Scand J Med Sci Sports. 2015 Jun;25(3):346-55. doi: 10.1111/sms.12228. Epub 2014 Apr 10.

    PMID: 24716522BACKGROUND
  • Johannsen F, Olesen JL, Ohlenschlager TF, Lundgaard-Nielsen M, Cullum CK, Jakobsen AS, Rathleff MS, Magnusson PS, Kjaer M. Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2219661. doi: 10.1001/jamanetworkopen.2022.19661.

    PMID: 35816306BACKGROUND

Study Officials

  • Muniba Afzal

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

September 1, 2023

Primary Completion

December 20, 2023

Study Completion

January 5, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations