Combined Effect of Foam Roller and Gastrocnemius Release on Plantar Fasciitis (MTP)

January 21, 2024 updated by: Aya Samir Mohamed Bagory, Cairo University
this study will be conducted to investigate the efficacy of combining foam roller and gastrocnemius release on pain intensity level, dorsi flexion range of motion of ankle joint ,dorsi flexion range of motion of big toe and foot function in subjects with plantar fasciitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Plantar fasciitis refers to degeneration and inflammation of the proximal plantar fascia. The condition presents with plantar medial heel pain, often exacerbated following periods of inactivity, such as upon waking in the morning.The term "plantar fasciitis" has been quoted for years, but this is a misnomer as inflammatory cells are not present in biopsies from involved fascia. Therefore, advocate the terminology "plantar fasciitis" to explain the syndrome characterized by pain along the proximal plantar fascia and its attachment in the area of the calcaneal tuberosity with function impairment, implying a more chronic degenerative process than acute heel pain.Research found that both stretching and foam rolling techniques helped reduce pain and increase the ROM. However, the effectiveness of foam rolling was superior to stretching in terms of increased pressure pain thresholds (PPTs) at gastrocnemius and soleus. there was a gap in the previous literature in combined effect of gastrocnemius release and foam roller in managing plantar fasciitis and assessing dorsi flexion range of motion of both big toe and ankle joint along with pain assessment and foot function. sixty patients with planter fascitis will be assigned randomly to two groups; first one will receive manual and foam roller release of gastrocnemius and conventional treatment and the other one will receive conventional treatment only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged between 18 years and 60 years
  • heel pain in the morning with first step, insidious sharp pain under the heel, tenderness on medial calcaneus and symptoms decreasing with slight activity (like walking) and worsening toward the end of the day

Exclusion Criteria:

  • Infective conditions of foot, tumor, calcaneal fracture
  • Metal implant around ankle
  • Dermatitis, acute sepsis and anesthetic areas
  • Subject with impaired circulation to lower extremities
  • Subject with referred pain due to sciatica
  • Corticosteroids
  • Injection in heel preceding 3 month
  • Patient who cannot co-operate
  • history of flat foot

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: conventional treatment
the patients will receive conventional treatment three times a week for four weeks
Other: conventional treatment
the patients will receive conventional treatment in the form of ultrasound therapy (continuous mode/1MHZ) followed by plantar fascia stretch and inctruction
Experimental: gastrocnemius release
the patients will receive gastrocnemius release manually and by foam roller three times a week for four weeks plus conventional treatment
Other: gastrocnemius release
The patient will be prone to lying and the therapist will stand at the side of the patient's leg. The therapist uses both hands in cross-hand pattern (Figure 10a and 10b). Myofascial Release will be performed for 20 repetitions, then gastrocnemius release by foam roller;This involved long sitting, with the affected leg will be extended on the foam roller and foot relaxed. The non-affected leg will be flexed at knee so that the foot will be rested on the floor. The participants will be instructed to use their arms and non_affected foot to propel their body back and forth from the popliteal fossa to Achilles tendon in continuous motion. then patients perform plantar fascia realise from standing by foam roller
Other: conventional treatment
the patients will receive conventional treatment in the form of ultrasound therapy (continuous mode/1MHZ) followed by plantar fascia stretch and inctruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain intensity level
Time Frame: up to four weeks
visual analogue scale will be used for assess pain intensity level. VAS was a 10-cm-long horizontal line with no pain and worst possible pain at the extremes of the line
up to four weeks
ankle dorsiflexion
Time Frame: up to four weeks
Electro goniometers are electronic versions of the standard goniometers used in the clinic to measure ankle dorsiflexion ROM
up to four weeks
foot function
Time Frame: up to four weeks
The foot function index (questionnaire) will be used to assess foot function. it consists of 23 self-reported items divided into 3 subcategories based on patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help)
up to four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
big toe range of motion
Time Frame: up to four weeks
Electro goniometers are electronic versions of the standard goniometers used in the clinic to measure big toe range of motion
up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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