Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
1 other identifier
interventional
120
1 country
1
Brief Summary
This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 14, 2016
October 1, 2016
1 year
October 11, 2016
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change
The American Orthopedic Foot and Ankle Society Score (AOFAS) is one of most widely used clinician-reporting tools for foot and ankle conditions. Developed in 1994, it is a clinician-based score that measures outcomes for four different anatomic regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes. The four anatomic regions of the AOFAS are all represented by a different version of the survey with each tool designed to be used independently. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The SF-36v2 Health Survey (SF-36v2) - Change
The SF-36v2 Health Survey is a multipurpose, short-form health survey with 36 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index. Like its predecessor, the SF-36 Health Survey , the SF-36v2 is a generic measure of health status, as opposed to one that targets a specific age, disease, or treatment group. It has proven useful for conducting surveys of general and specific populations, comparing the relative burden of diseases, and differentiating the health benefits produced by a wide range of treatments.
Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The Laitinen Pain Indicator Questionnaire
The Laitinen Pain Indicator Questionnaire is subjective and point tool which is used to assess the level of pain. Patients have to evaluate four indicators: pain intensity, the frequency of pain, the frequency of use of analgesics and physical activity limitations. Each indicator score is assigned from 0 to 4, with 0 being no problem, and four being a maximum problem.
Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
Secondary Outcomes (3)
Two weights test
Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Heel standing test
Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
The Visual Analogue Scale
Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Study Arms (4)
Group 1 - ESWT Treatment
ACTIVE COMPARATORPatients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks
Group 2 - Body Wave
ACTIVE COMPARATORPatients treated with electric field diathermy three times a week for 5 weeks
Group 3 - Ultrasound
ACTIVE COMPARATORPatients treated with ultrasound therapy three times a week for 5 weeks
Group 4 - Control group
SHAM COMPARATORPatients treated with sham laser therapy three times a week for 5 weeks
Interventions
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
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
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 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
Eligibility Criteria
You may qualify if:
- heel spur (calcaneal spur) diagnosed by a doctor based on X-ray examination, diagnostic ultrasonography or MR
- signed informed consent
- heel pain for at least one month
You may not qualify if:
- pregnancy
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Non-public health care facility "NZOZ Komed"
Lodz, Łódź Voivodeship, 90-009, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalia Kociuga, master
Medical University of Lodz, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Physical Therapy
Study Record Dates
First Submitted
October 11, 2016
First Posted
October 14, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2017
Study Completion
June 1, 2018
Last Updated
October 14, 2016
Record last verified: 2016-10