Calcaneal SpurNCT05373225
Shockwave Phonophoresis on Calcaneal Spur Patients
A study testing Acetic acid shockwave phonophoresis therapy, Shock wave Therapy and conventional physical therapy program in people with Calcaneal Spur, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Calcaneal Spur
- What is being tested?
- Acetic acid shockwave phonophoresis therapy, Shock wave Therapy and conventional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2022to 15 Dec 2022
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heel pain with a calcaneal spur.
- Calcaneal spur in a lateral calcaneal x-ray.
- Patient's age ranged from 30 to 65 years.
- Patients with a calcaneal spur.
- Patients with intact sensory perception.
- At least 6 weeks from last corticosteroid injection; 4 weeks from the last local anaesthetic injection, iontophoresis, ultrasound, and electrotherapy
Who cannot join
- History of fracture or surgery of the heel or ankle.
- Presence of inflammatory joint disease.
- Marked osteoporotic patient.
- Presence of ankylosing spondylitis or other inflammatory joint diseases.
- Heart pacemaker use.
- Patient on anticoagulant and coagulation disease.
- Skin wound or ulcers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza
Nabil Abdel-Aal, PhD, +201200133613, nabil.mahmoud@cu.edu.eg
Nabil M Abdel-Aal, PHD
About this study
Official title: Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal Spur Patients: A Randomized Controlled Trial
The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patients and also might improve the quality of life in a fast and efficient way.
- Conditions
- Calcaneal Spur
- Being tested
- Acetic acid shockwave phonophoresis therapy, Shock wave Therapy, conventional physical therapy program
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic acid shockwave phonophoresis therapyDevice
This group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice
Shock wave TherapyDevice
This group composed of subjects and represented the control group who will receive shock wave therapy
conventional physical therapy programOther
Exercise program:
- Standing calf-stretching exercise
- Towel stretch: stretching exercise
- Ice bottle
- Towel pickup exercise
- Marble pickups exercise
- Calf raises exercises -Static and dynamic balance exercise
| Study group | Role | What they receive |
|---|---|---|
| Shock wave Therapy | Experimental | This group will be composed of subjects who represented the experimental group 1. They will receive shock wave therapy Receives: Device: Shock wave Therapy |
| Acetic acid shockwave phonophoresis therapy | Experimental | This group will be composed of subjects who represented the experimental group 2. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice Receives: Device: Acetic acid shockwave phonophoresis therapy |
| conventional physical therapy program | Active comparator | This group will be composed of subjects who represented the control group
Exercise program:
* Standing calf-stretching exercise
* Towel stretch: stretching exercise
* Ice bottle
* Towel pickup exercise
* Marble pickups exercise
* Calf raises exercises -Static and dynamic balance exercise Receives: Other: conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcaneal spur length by X-ray (mm)
X-ray on the affected foot to measure the length of the calcaneal spur
Measured: three months
calcaneal spur width by X-ray (mm)
X-ray on the affected foot to measure the width of the calcaneal spur
Measured: three months
Secondary outcomes (3)
FPX 50 wagner Pressure pain threshold (PPT)
this device used to measure the pressure pain threshold
Measured: three months
Activity of daily living: by Foot and Ankle Ability Measure scale
This scale formed from 29 item, the minimum score for each item is 0 and maximum score is 4 , the Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction
Measured: three months
visual analogue scale.
this scale for pain intensity level assessment and contain minimum score is 0 and maximum score is 100 mm, the higher score indicate more pain (sever dysfunction)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Dec 2022 (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 Beni-Suef 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Self
- Responsible party
- Principal investigator, Mostafa Ali Elwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373225
- Sponsor's protocol ID
- shockwave phonophoresis
- Status last verified
- Jul 2022
- First submitted
- 17 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal Spur Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05373225
- Acronym / sponsor ID
- shockwave phonophoresis
- Conditions
- Calcaneal Spur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Self
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 13 May 2022 (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.
The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patients and also might improve the quality of life in a fast and efficient way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shock wave Therapy | Experimental | Device: Shock wave TherapyThis group will be composed of subjects who represented the experimental group 1. They will receive shock wave therapy |
| Acetic acid shockwave phonophoresis therapy | Experimental | Device: Acetic acid shockwave phonophoresis therapyThis group will be composed of subjects who represented the experimental group 2. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice |
| conventional physical therapy program | Active comparator | Other: conventional physical therapy programThis group will be composed of subjects who represented the control group Exercise program: * Standing calf-stretching exercise * Towel stretch: stretching exercise * Ice bottle * Towel pickup exercise * Marble pickups exercise * Calf raises exercises -Static and dynamic balance exercise |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Heel pain with a calcaneal spur.
- Calcaneal spur in a lateral calcaneal x-ray.
- Patient's age ranged from 30 to 65 years.
- Patients with a calcaneal spur.
- Patients with intact sensory perception.
Key exclusion criteria (7 listed)
- History of fracture or surgery of the heel or ankle.
- Presence of inflammatory joint disease.
- Marked osteoporotic patient.
- Presence of ankylosing spondylitis or other inflammatory joint diseases.
- Heart pacemaker use.
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 |
|---|---|---|
| Acetic acid shockwave phonophoresis therapyThis group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice | Device | Acetic acid shockwave phonophoresis therapy |
| Shock wave TherapyThis group composed of subjects and represented the control group who will receive shock wave therapy | Device | Shock wave Therapy |
| conventional physical therapy programExercise program: * Standing calf-stretching exercise * Towel stretch: stretching exercise * Ice bottle * Towel pickup exercise * Marble pickups exercise * Calf raises exercises -Static and dynamic balance exercise | Other | conventional physical therapy program |
Primary outcome
calcaneal spur length by X-ray (mm)
Time frame: three months
X-ray on the affected foot to measure the length of the calcaneal spur
calcaneal spur width by X-ray (mm)
Time frame: three months
X-ray on the affected foot to measure the width of the calcaneal spur
3 secondary outcomes
FPX 50 wagner Pressure pain threshold (PPT)
Time frame: three months
Activity of daily living: by Foot and Ankle Ability Measure scale
Time frame: three months
visual analogue scale.
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic acid shockwave phonophoresis therapy, Shock wave Therapy and conventional physical therapy program in people with Calcaneal Spur, run by Beni-Suef University at 1 site in Egypt.
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 6 inclusion and 7 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calcaneal spur length by X-ray (mm) (time frame: three months). The study lists 2 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 19 Jul 2022.