NCT06231199

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
unknown

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

January 21, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 21, 2024

Last Update Submit

January 21, 2024

Conditions

Keywords

foam rollergastrocnemius releaseplantar fascitis

Outcome Measures

Primary Outcomes (3)

  • pain intensity level

    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

    Electro goniometers are electronic versions of the standard goniometers used in the clinic to measure ankle dorsiflexion ROM

    up to four weeks

  • foot function

    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 Outcomes (1)

  • big toe range of motion

    up to four weeks

Study Arms (2)

gastrocnemius release

EXPERIMENTAL

the patients will receive gastrocnemius release manually and by foam roller three times a week for four weeks plus conventional treatment

Other: gastrocnemius releaseOther: conventional treatment

conventional treatment

ACTIVE COMPARATOR

the patients will receive conventional treatment three times a week for four weeks

Other: conventional treatment

Interventions

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

gastrocnemius release

the patients will receive conventional treatment in the form of ultrasound therapy (continuous mode/1MHZ) followed by plantar fascia stretch and inctruction

conventional treatmentgastrocnemius release

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: foam roller combined with gastrocnemius release and conventional treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator: aya samir mohamed bagory

Study Record Dates

First Submitted

January 21, 2024

First Posted

January 30, 2024

Study Start

January 25, 2024

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01