Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
NCT ID: NCT02934100
Last Updated: 2016-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-08-31
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis.
NCT06813105
Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei
NCT06356064
Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
NCT04836845
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
NCT04725513
Comparison of the Effectiveness of LLLT and ESWT in Plantar Fasciitis Treatment
NCT04826263
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* ESWT (once a week for 10 weeks)
* ultrasound (three times a week for 5 weeks)
* electric field diathermy (three times a week for 5 weeks).
Patients allocated in control group, will receive a sham laser therapy (only the timer on the machine activated) three times a week for 5 weeks.
Regardless of affiliation to the group, each patient will also receive kinesiotherapy treatment.
At the beginning of the study, each patient receives the "Information for the patient," describing the exact course of each stage of the study, then signs a "Form of informed consent to participate in the study.". The next stage of the study is to fill in the participant survey questionnaire and physical examination provided by the researcher.
Assessment of improvements will be made twice: right after the therapy and two months later. Every stage of the study is carried out by one and the same investigator.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 - ESWT Treatment
Patients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks
Shock Master 300
Extracorporeal Shock Wave Therapy
In all treatments (from 1 to 10) applied number of pulses is 4500 and the frequency is based on the patients feelings (from 8 to 12 Hz). Variable is the pressure:
Treatment 1 - 2,5 Bar; Treatment 2 - 2,6 Bar; Treatment 3 - 2,7 Bar; Treatment 4 - 2,8 Bar; Treatment 5 - 3,0 Bar; Treatment 6 - 3,2 Bar; Treatment 7 - 3,4 Bar; Treatment 8 - 3,6 Bar; Treatment 9 - 3,8 Bar; Treatment 10 - 4,0 Bar.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Group 2 - Body Wave
Patients treated with electric field diathermy three times a week for 5 weeks
Skanlab 25 BODYWAVE
Electric field diathermy therapy - Capacitive energy transfer system (CETS)
Time of each treatment (from 1 to 15) is eight minutes. Variable is the energy:
Treatment 1 - 3; Treatment 2 - 3; Treatment 3 - 4; Treatment 4 - 4; Treatment 5 - 5; Treatment 6 - 5; Treatment 7 - 6; Treatment 8 - 6; Treatment 9 - 7; Treatment 10 - 7; Treatment 11 - 7; Treatment 12 - 7; Treatment 13 - 7; Treatment 14 - 7; Treatment 15 - 7.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Group 3 - Ultrasound
Patients treated with ultrasound therapy three times a week for 5 weeks
EVO US13 CosmoGamma
Ultrasound therapy
Doses applied as following:
Each treatment (from 1 to 15) is pulsed ultrasound (1MHz, pulsed 1:4). Variable is the time and intensity:
Treatment 1 - 4 minutes, 0,4 W/cm2; Treatment 2 - 5 minutes, 0,4 W/cm2; Treatment 3 - 5 minutes, 0,5 W/cm2; Treatment 4 - 6 minutes, 0,5 W/cm2; Treatment 5 - 6 minutes, 0,6 W/cm2; Treatment 6 - 6 minutes, 0,6 W/cm2; Treatment 7 - 6 minutes, 0,6 W/cm2; Treatment 8 - 6 minutes, 0,7 W/cm2; Treatment 9 - 7 minutes, 0,7 W/cm2; Treatment 10 - 7 minutes, 0,7 W/cm2; Treatment 11 - 7 minutes, 0,8 W/cm2; Treatment 12 - 8 minutes, 0,8 W/cm2; Treatment 13 - 8 minutes, 0,8 W/cm2; Treatment 14 - 8 minutes, 0,8 W/cm2; Treatment 15 - 8 minutes, 0,8 W/cm2.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Group 4 - Control group
Patients treated with sham laser therapy three times a week for 5 weeks
Sham LASER CTL1106MX
Sham laser therapy Time of each treatment (from 1 to 15) is four to five minutes. Developed is 10 points, each point takes 15 seconds. Device is unplugged and it does not emit any radiation.The patient does not know that the procedure is not really executed.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Shock Master 300
Extracorporeal Shock Wave Therapy
In all treatments (from 1 to 10) applied number of pulses is 4500 and the frequency is based on the patients feelings (from 8 to 12 Hz). Variable is the pressure:
Treatment 1 - 2,5 Bar; Treatment 2 - 2,6 Bar; Treatment 3 - 2,7 Bar; Treatment 4 - 2,8 Bar; Treatment 5 - 3,0 Bar; Treatment 6 - 3,2 Bar; Treatment 7 - 3,4 Bar; Treatment 8 - 3,6 Bar; Treatment 9 - 3,8 Bar; Treatment 10 - 4,0 Bar.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Skanlab 25 BODYWAVE
Electric field diathermy therapy - Capacitive energy transfer system (CETS)
Time of each treatment (from 1 to 15) is eight minutes. Variable is the energy:
Treatment 1 - 3; Treatment 2 - 3; Treatment 3 - 4; Treatment 4 - 4; Treatment 5 - 5; Treatment 6 - 5; Treatment 7 - 6; Treatment 8 - 6; Treatment 9 - 7; Treatment 10 - 7; Treatment 11 - 7; Treatment 12 - 7; Treatment 13 - 7; Treatment 14 - 7; Treatment 15 - 7.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
EVO US13 CosmoGamma
Ultrasound therapy
Doses applied as following:
Each treatment (from 1 to 15) is pulsed ultrasound (1MHz, pulsed 1:4). Variable is the time and intensity:
Treatment 1 - 4 minutes, 0,4 W/cm2; Treatment 2 - 5 minutes, 0,4 W/cm2; Treatment 3 - 5 minutes, 0,5 W/cm2; Treatment 4 - 6 minutes, 0,5 W/cm2; Treatment 5 - 6 minutes, 0,6 W/cm2; Treatment 6 - 6 minutes, 0,6 W/cm2; Treatment 7 - 6 minutes, 0,6 W/cm2; Treatment 8 - 6 minutes, 0,7 W/cm2; Treatment 9 - 7 minutes, 0,7 W/cm2; Treatment 10 - 7 minutes, 0,7 W/cm2; Treatment 11 - 7 minutes, 0,8 W/cm2; Treatment 12 - 8 minutes, 0,8 W/cm2; Treatment 13 - 8 minutes, 0,8 W/cm2; Treatment 14 - 8 minutes, 0,8 W/cm2; Treatment 15 - 8 minutes, 0,8 W/cm2.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Sham LASER CTL1106MX
Sham laser therapy Time of each treatment (from 1 to 15) is four to five minutes. Developed is 10 points, each point takes 15 seconds. Device is unplugged and it does not emit any radiation.The patient does not know that the procedure is not really executed.
Each patient will also receive kinesiotherapy treatment that will consist of:
* eight-minute massage of posterior lower leg muscles
* plantar aponeurosis stretching
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* signed informed consent
* heel pain for at least one month
Exclusion Criteria
* generalized acute infection (fever, cough, runny nose)
* local infection in the treated leg (wound, swelling)
* cancer
* injections of corticosteroids in the last six weeks
* pacemaker
* acute inflammation of the joints of the lower limbs
* inflammation of the veins
* Fresh fractures, post-traumatic
* osteoporosis
* Reynaud's disease
* Burger disease
* atherosclerosis
* after surgery condition before removing stitches
* High blood pressure
* after CT with contrast condition in the last two weeks
* The state of the lumbar puncture
* Strong imbalance
* Condition after myocardial infarction in the last six weeks
* Rheumatoid arthritis
* Ankylosing spondylitis
* Significant leg ulcers
* diabetes
* The risk of bleeding in the muscle tissue
* Thromboangiitis
* Hypersensitivity skin in the treated section
* A tendency to hemorrhage
* Pathological arrogance bone under the skin in the treated section
* Metal implants and surgical implants in the area of the lower limb subjected to therapy
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Lodz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Natalia Kociuga
Master of Physical Therapy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Natalia Kociuga, master
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz, Poland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Non-public health care facility "NZOZ Komed"
Lodz, Łódź Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
review article describing what the "heel spurs" really are and what are their consequences
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RNN/47/16/KE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.