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Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur

Primary Purpose

Heel Spur, Calcaneal Spur

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Shock Master 300

Skanlab 25 BODYWAVE

EVO US13 CosmoGamma

Sham LASER CTL1106MX

About this trial

This is an interventional treatment trial for Heel Spur focused on measuring Calcaneal spur, Heel spur, ESWT, Extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy, skanlab 25 bodywave, sham laser therapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Non-public health care facility "NZOZ Komed"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1 - ESWT Treatment

Group 2 - Body Wave

Group 3 - Ultrasound

Group 4 - Control group

Arm Description

Patients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks

Patients treated with electric field diathermy three times a week for 5 weeks

Patients treated with ultrasound therapy three times a week for 5 weeks

Patients treated with sham laser therapy three times a week for 5 weeks

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Two weights test

The two weights test is measures the uniformity of the load of the lower limbs. The patient gets the right lower limb on one scale and another limb on the other scale. By standing on the scales must look ahead. The range of measurement error is five kilograms.

Heel standing test

The heel standing test is to measure the intensity of pain experienced by burdening calcaneus. The patient is standing by the wall and must stand on both heel bones at the same time, then turn on the right calcaneus and then on the left calcaneus. Each of the three above mentioned activities is assessed using a three-point scale, depending on the feasibility of the task by the patient: job done at 100-75% without much problem, the task done at 75-25% with difficulty, the task done at 25-0% with great difficulty, or not done at all. The test was created for this study and a researcher authorship.

The Visual Analogue Scale

The visual analogue scale is a measurement instrument that is used for subjective assessment of pain made by the patient. The pain can be evaluated in a ten-point scale, where one represents no pain and ten is the pain unbearable.

Full Information

NCT ID

NCT02934100

First Posted

October 11, 2016

Last Updated

October 12, 2016

Sponsor

Medical University of Lodz

1. Study Identification

Unique Protocol Identification Number

NCT02934100

Brief Title

Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur

Official Title

Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Lodz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Number of 120 diagnosed with heel spur patients, will be allocated randomly into one of three treatment groups or into the control group. Assignment to a group is random, but before that happens patients will be questioned about inclusion and exclusion criteria of the study. Depending on group allocation, patients in treatment groups will receive one of the following physical therapy treatments: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heel Spur, Calcaneal Spur

Keywords

Calcaneal spur, Heel spur, ESWT, Extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy, skanlab 25 bodywave, sham laser therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - ESWT Treatment

Arm Type

Active Comparator

Arm Description

Patients treated with Extracorporeal Shock Wave Therapy once a week for 10 weeks

Arm Title

Group 2 - Body Wave

Arm Type

Active Comparator

Arm Description

Patients treated with electric field diathermy three times a week for 5 weeks

Arm Title

Group 3 - Ultrasound

Arm Type

Active Comparator

Arm Description

Patients treated with ultrasound therapy three times a week for 5 weeks

Arm Title

Group 4 - Control group

Arm Type

Sham Comparator

Arm Description

Patients treated with sham laser therapy three times a week for 5 weeks

Intervention Type

Device

Intervention Name(s)

Shock Master 300

Other Intervention Name(s)

produced by GYMNA

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Skanlab 25 BODYWAVE

Other Intervention Name(s)

produced by SKANLAB AS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

EVO US13 CosmoGamma

Other Intervention Name(s)

produced by EMILDUE

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham LASER CTL1106MX

Other Intervention Name(s)

produced by CTL

Intervention Description

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

Primary Outcome Measure Information:

Title

The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change

Description

Time Frame

Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.

Title

The SF-36v2 Health Survey (SF-36v2) - Change

Description

Time Frame

Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.

Title

The Laitinen Pain Indicator Questionnaire

Description

Time Frame

Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.

Secondary Outcome Measure Information:

Title

Two weights test

Description

Time Frame

Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.

Title

Heel standing test

Description

Time Frame

Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.

Title

The Visual Analogue Scale

Description

Time Frame

Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Natalia Kociuga, master

Phone

+48609018609

nkociuga@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marta Woldańska-Okońska, professor

Phone

+48662130860

marta.woldanska-okonska@umed.lodz.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalia Kociuga, master

Organizational Affiliation

Medical University of Lodz, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Non-public health care facility "NZOZ Komed"

City

Lodz

ZIP/Postal Code

90-009

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natalia Kociuga, master

Phone

+48609018609

nkociuga@gmail.com

First Name & Middle Initial & Last Name & Degree

Marta Woldańska-Okońska, Professor

Phone

+48662130860

marta.woldanska-okonska@umed.lodz.pl

12. IPD Sharing Statement

Links:

URL

http://czyrny.pl/pdf/Art_01_czyrny.JOTSRR.2.2010.pdf

Description

review article describing what the "heel spurs" really are and what are their consequences

Learn more about this trial

Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur

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