NCT06139822

Brief Summary

The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

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

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

January 4, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

Planter Faciatis

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    The visual analogue scale (VAS) is a scale that is used as a questionnaire. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end points.patient rates its pain between 0 to 10. VAS Visual Analogue Scale changes measured at baseline after 1 week and sfter 2nd week.

    upto 2 weeks

Secondary Outcomes (2)

  • Goniometery for ROM(Range of Motion)

    upto 2 weeks

  • Functional Foot Index (FFI-R)

    upto 2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

hamstring stretching, cold pack, stretching, strengthening of plantar fascia and calf muscles. . Hamstring stretching will be used as an intervention protocol along with conventional physical therapy. Treatment protocol will be followed for thrice a week for 2 weeks. The session will be of approximately 20 minutes. Patient will be in supine lying, passively increase hip flexion while keeping the back straight, and the knee in the extended position from the start to the end of the stretching while the ankle will be in a neutral position a 30-second rest period will be recommended between stretching repetitions. For each stretching repetition, the individual had to achieve a position of mild discomfort (not pain) which will sustain for 30 seconds.

Other: Experimental Group

Control Group

ACTIVE COMPARATOR

Cold pack, stretching, strengthening of plantar fascia and calf muscles Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia through: * toe stretches to stretch the plantar fascia. * towel to stretch the bottom of foot (towel scrunches) * calf muscles stretching After stretching exercises strengthening is performed by the following: * towel curls * heel raise Patients performed 2 sets, each repetition lasting 30 seconds, 2 times a day for each exercise.

Other: Control Group

Interventions

Hamstring stretching is the main intervention which is being used along with convention protocol for plantar fasciitis.

Also known as: Hamstring Streching
Experimental Group

Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia .

Also known as: cold pack, calf and plantar fascia stretchings and strenthening exercises
Control Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Genders
  • to 45 years of age
  • Participants having heel pain for more than one month.
  • Participants having Windlass positive test.
  • Participants having hamstring tightness.
  • sit and reach test positive.
  • Bilateral plantar fasciitis.

You may not qualify if:

  • Patients with corticosteroid injection
  • Fracture around ankle and Calcaneal
  • Any soft tissue injuries around ankle.
  • Other Neurological/ Musculoskeletal disorder
  • Congenital foot anomalies
  • Systemic medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

November 18, 2023

Study Start

February 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 25, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations