Heel SpurNCT01510249
A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur
An observational study of Heel Spur, run by Medical University of Lodz.
Trial summary
Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel and it makes walking limited or even impossible. The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in patients with heel spur. Read more about this study
- Who is it for?
- Ages 38 to 86 years
- Conditions the study is for
- Heel Spur
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2011
- Phase
- Observational
- 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 38 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted on a group of 52 patients of both sexes, aged 38-86 years (mean 57.39; SD-11.5) with a plantar calcaneal spur confirmed by X-ray images. Patients were treated in the Department of Physical Medicine and Rehabilitation Day Unit of the University Hospital im. WAM - Central Veterans Hospital in Lodz and Municipal Health Clinic of Andrespol. In order to compare the effectiveness of the two forms of physiotherapy, ultrasound and radial shock wave therapy, the patients were randomly assigned (using a simple randomization) into two groups: * Group 1 - ultrasound therapy group: 22 patients aged 38-86 years (mean 58.64; SD-12.99), * Group 2 - radial shock wave group: 30 patients aged 40-71 years (mean 56.13; SD-10.02).
Who may be able to join
- plantar calcaneal spur confirmed by X-ray images
Who cannot join
- contraindications for physical therapy
About this study
Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel and it makes walking limited or even impossible.
The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in patients with heel spur.
The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel spur confirmed radiographically. The patients were randomly divided into two groups;in Group 1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock wave procedure(6 treatments). The researchers assessed pain three times (prior to the therapy, after the first and then the second week of treatment). In order to do this they used a modified form of the Laitinen pain indicators questionnaire (results expressed in points) and VAS - visual analogue scale (results given in milimeters). The results were statistically analyzed. In the studied periods of time a decrease in pain was observed (both in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both the groups after the first week of treatment. Ultrasound and shock wave therapies show a comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has an advantage over ultrasound therapy. A smaller number of procedures is required to obtain comparable results, which makes the therapy less expensive. No side effects were observed during and after the treatment.
Read the detailed description
The study was conducted on a group of 52 patients of both sexes, aged 38-86 years (mean 57.39; SD-11.5) with a plantar calcaneal spur confirmed by X-ray images. Patients were treated in the Department of Physical Medicine and Rehabilitation Day Unit of the University Hospital im. WAM - Central Veterans Hospital in Lodz and Municipal Health Clinic of Andrespol. In order to compare the effectiveness of the two forms of physiotherapy, ultrasound and radial shock wave therapy, the patients were randomly assigned (using a simple randomization) into two groups:
- Group 1 - ultrasound therapy group: 22 patients aged 38-86 years (mean 58.64; SD-12.99),
- Group 2 - radial shock wave group: 30 patients aged 40-71 years (mean 56.13; SD-10.02).
Ultrasound (US) was performed with a BTL 5840 S device, using labile technique, targeting the calcaneal tumor and attachment of the plantar aponeurosis (pain points); the power setting was 1,5 W/cm2, 80% fill factor, at a frequency of 1 MHz (head 4cm2). The duration of a single treatment was four minutes, and the coupling substance used was paraffin oil. Treatment sessions were performed daily Monday through Friday for a period of two weeks in a series of 10 treatments.
The shock wave therapy (SWT) was performed on the affected area using a BTL-5000 SWT device connected to a 15 mm diameter applicator according to the producer's recommendations; during therapy, 2000 strokes were applied with a frequency of 10 Hz and a capacity of 2.5 bar. Therapy took place for two weeks in a series of 6 treatments with a two-day interval between treatments.
In addition, all patients underwent kinesitherapy - exercises to strengthen the muscles that bending plantar and supinated foot to improve the mobility of the feet and to maintain the normal longitudinal arch of the foot. SPR orthopedic inserts with a pit on the painful area was used to support the longitudinal foot arch and relieve the medial ridge of the calcaneal tumor.
In all patients, pain intensity was assessed three times: before therapy, and after the first and second week of treatment. A modified form of the Laitinen indicators of pain question-shem was used [12]. On the basis of their subjective feelings, patients evaluated pain intensity, frequency of occurrence, use of analgesics, and the impact of pain on their physical activity. In addition, pain intensity was also assessed on the Huskisson visual - analogue scale (VAS) [13]; patients marked a point on a 100 mm line which corresponded to the current pain sensations - the results being given in millimeters.
The results were analyzed by Student's t-test for dependent and independent tests, with a significance level of p <0.05. The results are presented as arithmetic mean and standard deviation.
- Conditions
- Heel Spur
- Keywords
- calcaneal spur, shock wave therapy, ultrasound therapy
- Medical subject headings
- Heel Spur
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur
Measured: two weeks in a series of 10 ultrasound treatments and 6 radial shock wave treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel SpurStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Krukowska, Medical University of Lodz
- Investigators
- Jolanta Krukowska, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510249
- Sponsor's protocol ID
- JKrukowska01
- Status last verified
- Jan 2012
- First submitted
- 16 Dec 2011
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur
- ClinicalTrials.gov ID
- NCT01510249
- Acronym / sponsor ID
- JKrukowska01
- Conditions
- Heel Spur
- Keywords
- calcaneal spur, shock wave therapy, ultrasound therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jan 2012 (estimated)
- 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.
Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel and it makes walking limited or even impossible.
The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in patients with heel spur.
The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel spur confirmed radiographically. The patients were randomly divided into two groups;in Group 1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock wave procedure(6 treatments). The researchers assessed pain three times (prior to the therapy, after the first and then the second week of treatment). In order to do this they used a modified form of the Laitinen pain indicators questionnaire (results expressed in points) and VAS - visual analogue scale (results given in milimeters). The results were statistically analyzed. In the studied periods of time a decrease in pain was observed (both in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both the groups after the first week of treatment. Ultrasound and shock wave therapies show a comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has an advantage over ultrasound therapy. A smaller number of procedures is required to obtain comparable results, which makes the therapy less expensive. No side effects were observed during and after the treatment.
Detailed description
The study was conducted on a group of 52 patients of both sexes, aged 38-86 years (mean 57.39; SD-11.5) with a plantar calcaneal spur confirmed by X-ray images. Patients were treated in the Department of Physical Medicine and Rehabilitation Day Unit of the University Hospital im. WAM - Central Veterans Hospital in Lodz and Municipal Health Clinic of Andrespol. In order to compare the effectiveness of the two forms of physiotherapy, ultrasound and radial shock wave therapy, the patients were randomly assigned (using a simple randomization) into two groups:
- Group 1 - ultrasound therapy group: 22 patients aged 38-86 years (mean 58.64; SD-12.99),
- Group 2 - radial shock wave group: 30 patients aged 40-71 years (mean 56.13; SD-10.02).
Ultrasound (US) was performed with a BTL 5840 S device, using labile technique, targeting the calcaneal tumor and attachment of the plantar aponeurosis (pain points); the power setting was 1,5 W/cm2, 80% fill factor, at a frequency of 1 MHz (head 4cm2). The duration of a single treatment was four minutes, and the coupling substance used was paraffin oil. Treatment sessions were performed daily Monday through Friday for a period of two weeks in a series of 10 treatments.
The shock wave therapy (SWT) was performed on the affected area using a BTL-5000 SWT device connected to a 15 mm diameter applicator according to the producer's recommendations; during therapy, 2000 strokes were applied with a frequency of 10 Hz and a capacity of 2.5 bar. Therapy took place for two weeks in a series of 6 treatments with a two-day interval between treatments.
In addition, all patients underwent kinesitherapy - exercises to strengthen the muscles that bending plantar and supinated foot to improve the mobility of the feet and to maintain the normal longitudinal arch of the foot. SPR orthopedic inserts with a pit on the painful area was used to support the longitudinal foot arch and relieve the medial ridge of the calcaneal tumor.
In all patients, pain intensity was assessed three times: before therapy, and after the first and second week of treatment. A modified form of the Laitinen indicators of pain question-shem was used [12]. On the basis of their subjective feelings, patients evaluated pain intensity, frequency of occurrence, use of analgesics, and the impact of pain on their physical activity. In addition, pain intensity was also assessed on the Huskisson visual - analogue scale (VAS) [13]; patients marked a point on a 100 mm line which corresponded to the current pain sensations - the results being given in millimeters.
The results were analyzed by Student's t-test for dependent and independent tests, with a significance level of p <0.05. The results are presented as arithmetic mean and standard deviation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 38 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted on a group of 52 patients of both sexes, aged 38-86 years (mean 57.39; SD-11.5) with a plantar calcaneal spur confirmed by X-ray images. Patients were treated in the Department of Physical Medicine and Rehabilitation Day Unit of the University Hospital im. WAM - Central Veterans Hospital in Lodz and Municipal Health Clinic of Andrespol. In order to compare the effectiveness of the two forms of physiotherapy, ultrasound and radial shock wave therapy, the patients were randomly assigned (using a simple randomization) into two groups: * Group 1 - ultrasound therapy group: 22 patients aged 38-86 years (mean 58.64; SD-12.99), * Group 2 - radial shock wave group: 30 patients aged 40-71 years (mean 56.13; SD-10.02).
Key inclusion criteria (1 listed)
- plantar calcaneal spur confirmed by X-ray images
Key exclusion criteria (1 listed)
- contraindications for physical therapy
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
A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur
Time frame: two weeks in a series of 10 ultrasound treatments and 6 radial shock wave treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
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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.
Jolanta Krukowska, PhD principal investigator
Medical University of Lodz
Questions about this trial
What is this clinical trial studying?
An observational study of Heel Spur, run by Medical University of Lodz.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jan 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur (time frame: two weeks in a series of 10 ultrasound treatments and 6 radial shock wave treatments). 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 16 Jan 2012.