Plantar FascitisMTPNCT06231199
Combined Effect of Foam Roller and Gastrocnemius Release on Plantar Fasciitis
A study testing gastrocnemius release and conventional treatment in people with Plantar Fascitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- gastrocnemius release and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2024to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Injection in heel preceding 3 month
- Patient who cannot co-operate
- history of flat foot
About this study
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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- gastrocnemius release, conventional treatment
- Keywords
- foam roller, gastrocnemius release, plantar fascitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrocnemius releaseOther
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
conventional treatmentOther
the patients will receive conventional treatment in the form of ultrasound therapy (continuous mode/1MHZ) followed by plantar fascia stretch and inctruction
| Study group | Role | What they receive |
|---|---|---|
| gastrocnemius release | Experimental | the patients will receive gastrocnemius release manually and by foam roller three times a week for four weeks plus conventional treatment Receives: Other: gastrocnemius release; Other: conventional treatment |
| conventional treatment | Active comparator | the patients will receive conventional treatment three times a week for four weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to four weeks
ankle dorsiflexion
Electro goniometers are electronic versions of the standard goniometers used in the clinic to measure ankle dorsiflexion ROM
Measured: 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)
Measured: up to four weeks
Secondary outcomes (1)
big toe range of motion
Electro goniometers are electronic versions of the standard goniometers used in the clinic to measure big toe range of motion
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion25 Apr 2024 (estimated)
- Study completion25 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- foam roller combined with gastrocnemius release and conventional treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Samir Mohamed Bagory, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231199
- Sponsor's protocol ID
- P.T.REC/012/004276
- Acronym
- MTP
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Foam Roller and Gastrocnemius Release on Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06231199
- Acronym / sponsor ID
- MTP / P.T.REC/012/004276
- Conditions
- Plantar Fascitis
- Keywords
- foam roller, gastrocnemius release, plantar fascitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 25 Apr 2024 (estimated)
- Study completion
- 25 Apr 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- foam roller combined with gastrocnemius release and conventional treatment
| Arm | Type | Receives |
|---|---|---|
| gastrocnemius release | Experimental | Other: gastrocnemius release, Other: conventional treatmentthe patients will receive gastrocnemius release manually and by foam roller three times a week for four weeks plus conventional treatment |
| conventional treatment | Active comparator | Other: conventional treatmentthe patients will receive conventional treatment three times a week for four weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrocnemius releaseThe 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 | gastrocnemius release |
| conventional treatmentthe patients will receive conventional treatment in the form of ultrasound therapy (continuous mode/1MHZ) followed by plantar fascia stretch and inctruction | Other | conventional treatment, gastrocnemius release |
Primary outcome
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
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
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)
1 secondary outcome
big toe range of motion
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing gastrocnemius release and conventional treatment in people with Plantar Fascitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity level (time frame: up to four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.