Calcaneal SpurCSNCT06740617
Evaluation Of Balance And Ankle Proprioception In Calcaneal Spur Patients
An observational study of Calcaneal Spur, run by Cairo University.
Trial summary
this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Calcaneal Spur
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: fifty two subjects will be assigned to two group; group with calcaneal spur and healthy group
Who may be able to join
- age will range from 40-60
- both sex male and female
- unilateral calcaneal spur
- Patients with pain and inflammation at the bottom of heel, or the location where the spur is present.
- All subjects have body mass index less than 29 kg/cm2
- sharp pain like a knife in the heel when standing up in the morning
Show all 9Show fewer
- pain may also appear at the end of the day or after spending long periods of time on the feet
- sharp pain with the first steps in the morning or after a long period of rest and dissipating when weight bearing is initiated.
- All diagnosed patients, were evaluated and confirmed radiologically by specialist doctor, by performing a standard X-ray foot profile image
Who cannot join
- Surgery within the last 6 months
- Sensory or motor paralysis -Received steroid injections within the last 3 months-
- discrepancy in length of the lower extremities greater than or equal to 1 cm.
- systemic disease in the last six months that may predispose to heel pain(e.g., rheumatoid arthritis and lupus). (Dudoniene V et al.,2023).
- Calcaneal spurs are associated with various medical conditions, including obesity, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, Reiter's disease, and spondylarthritis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects
Read the detailed description
A calcaneal spur, also known as enthesophyte, is an abnormal bone outgrowth at the inferior part of the calcaneus, which is the most common site of bony spur occurrence. Although there is consensus that a calcaneal spur is a common cause of heel pain, approximately 20% of calcaneal spurs are asymptomatic and its pathology remains not fully understood.Ankle Joint Position Sense (JPS) refers to the ability to accurately perceive and reproduce the position of the ankle joint in space. Balance, on the other hand, encompasses the ankle joint's positional stability during both static and dynamic activities.Several investigations have demonstrated a significant association between ankle JPS and balance, indicating that individuals with better proprioceptive acuity in the ankle joint tend to exhibit superior postural stability, ). It was found that higher plantar fascia and heel fat pad stiffness and thickness are related to higher postural sway in anterior-posterior and medial-lateral directions based on the single-leg balance tests. These results suggest that the morphological and mechanical properties of plantar fascia and heel fat pad play an important role in balance performance.
- Conditions
- Calcaneal Spur
- Keywords
- calcaneal spur, balance, ankle proprioception
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| calcaneal spur group | twenty six patients with calcaneal spur will participate in this group | |
| healthy group | twenty six healthy subjects will participate in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic balance
the Biodex Balance System (BBS) ,Version 3.1, has been used to evaluate postural balance
Measured: up to one day
static balance
The single-leg stance balance test will be used to assess static balance.
Measured: up to one day
ankle propriception
digital inclinometer will be used to assessed ankle proprioception
Measured: up to one day
foot disability
A Foot Function Index (FFI) will be used to assess foot disability. The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes. The disability subcategory consists of 9 items and measures difficulty performing various functional activities because of foot problems, such as difficulty climbing stairs. The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. Both total and subcategory scores are calculated
Measured: up to one day
Secondary outcomes (1)
integrity of the plantar fascia ligament
The Windlass Test is a physical examination technique will be used to assess the integrity of the plantar fascia ligament in the foot. we evaluated the Windlass test, and found it had a high specificity, and a low level of sensitivity. It can be used as part of the clinician's armamentarium in evaluating patients with plantar fasciitis, and should be performed in a weightbearing position to maximize the sensitivity
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneal SpurStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Afifi Saad Mohamed Farahat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740617
- Sponsor's protocol ID
- P.T.REC/012/005501
- Acronym
- CS
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Balance And Ankle Proprioception In Calcaneal Spur Patients
- ClinicalTrials.gov ID
- NCT06740617
- Acronym / sponsor ID
- CS / P.T.REC/012/005501
- Conditions
- Calcaneal Spur
- Keywords
- calcaneal spur, balance, ankle proprioception
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 18 Dec 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 difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects
Detailed description
A calcaneal spur, also known as enthesophyte, is an abnormal bone outgrowth at the inferior part of the calcaneus, which is the most common site of bony spur occurrence. Although there is consensus that a calcaneal spur is a common cause of heel pain, approximately 20% of calcaneal spurs are asymptomatic and its pathology remains not fully understood.Ankle Joint Position Sense (JPS) refers to the ability to accurately perceive and reproduce the position of the ankle joint in space. Balance, on the other hand, encompasses the ankle joint's positional stability during both static and dynamic activities.Several investigations have demonstrated a significant association between ankle JPS and balance, indicating that individuals with better proprioceptive acuity in the ankle joint tend to exhibit superior postural stability, ). It was found that higher plantar fascia and heel fat pad stiffness and thickness are related to higher postural sway in anterior-posterior and medial-lateral directions based on the single-leg balance tests. These results suggest that the morphological and mechanical properties of plantar fascia and heel fat pad play an important role in balance performance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcaneal spur group | – | –twenty six patients with calcaneal spur will participate in this group |
| healthy group | – | –twenty six healthy subjects will participate in this group |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- fifty two subjects will be assigned to two group; group with calcaneal spur and healthy group
Key inclusion criteria (9 listed)
- age will range from 40-60
- both sex male and female
- unilateral calcaneal spur
- Patients with pain and inflammation at the bottom of heel, or the location where the spur is present.
- All subjects have body mass index less than 29 kg/cm2
Key exclusion criteria (5 listed)
- Surgery within the last 6 months
- Sensory or motor paralysis -Received steroid injections within the last 3 months-
- discrepancy in length of the lower extremities greater than or equal to 1 cm.
- systemic disease in the last six months that may predispose to heel pain(e.g., rheumatoid arthritis and lupus). (Dudoniene V et al.,2023).
- Calcaneal spurs are associated with various medical conditions, including obesity, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, Reiter's disease, and spondylarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dynamic balance
Time frame: up to one day
the Biodex Balance System (BBS) ,Version 3.1, has been used to evaluate postural balance
static balance
Time frame: up to one day
The single-leg stance balance test will be used to assess static balance.
ankle propriception
Time frame: up to one day
digital inclinometer will be used to assessed ankle proprioception
foot disability
Time frame: up to one day
A Foot Function Index (FFI) will be used to assess foot disability. The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes. The disability subcategory consists of 9 items and measures difficulty performing various functional activities because of foot problems, such as difficulty climbing stairs. The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. Both total and subcategory scores are calculated
1 secondary outcome
integrity of the plantar fascia ligament
Time frame: up to one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcaneal Spur, 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai A Farahat, master (01025038690, maiafifi85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic balance (time frame: up to one day). The study lists 4 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 18 Dec 2024.