- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06231199
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
60
Phase
- 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
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 |
Intervention / Treatment |
---|---|
Active Comparator: conventional treatment
the patients will receive conventional treatment three times a week for four weeks
|
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
|
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
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
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
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
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)
January 25, 2024
Primary Completion (Estimated)
April 25, 2024
Study Completion (Estimated)
April 25, 2024
Study Registration Dates
First Submitted
January 21, 2024
First Submitted That Met QC Criteria
January 21, 2024
First Posted (Actual)
January 30, 2024
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Plantar Fascitis
-
Cairo UniversityNot yet recruiting
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...RecruitingPlantar FascitisItaly
-
Chinese University of Hong KongRecruiting
-
Istanbul Medeniyet UniversityNot yet recruiting
-
Chinese University of Hong KongRecruitingPlantar FascitisHong Kong
-
Stanford UniversityNot yet recruitingPlantar Fascitis
-
Hospital for Special Surgery, New YorkActive, not recruiting
-
Riphah International UniversityCompletedPlantar FascitisPakistan
-
Universidad Miguel Hernandez de ElcheFundación para el Fomento de la Investigación Sanitaria y Biomédica de la...Not yet recruitingPlantar FascitisSpain
-
Sultan Qaboos UniversityRecruitingPlantar FascitisOman
Clinical Trials on gastrocnemius release
-
Riphah International UniversityCompleted
-
OhioHealthWithdrawnPlantar Fasciitis | Equinus DeformityUnited States
-
Institut National de la Santé Et de la Recherche...UnknownMuscle Disorder | Artery Disease
-
Peking University Third HospitalCompletedAcute Rupture of Achilles Tendon (Disorder)China
-
Ostfold Hospital TrustOslo University HospitalRecruitingChronic Pain | Achilles TendinopathyNorway
-
Ahram Canadian UniversityRecruiting
-
Oslo University HospitalActive, not recruitingPlantar FasciitisNorway
-
Riphah International UniversityCompletedPlantar FascitisPakistan
-
Universidade do Vale do ParaíbaUnknownCerebrovascular AccidentBrazil
-
Ostfold Hospital TrustActive, not recruitingChronic Plantar FasciitisNorway