Clinical trial NCT02934100: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change
timeFrame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
measure: The SF-36v2 Health Survey (SF-36v2) - Change
timeFrame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
measure: The Laitinen Pain Indicator Questionnaire
timeFrame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
Secondary outcomes:
measure: Two weights test
timeFrame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
measure: Heel standing test
timeFrame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
measure: The Visual Analogue Scale
timeFrame: Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Non-public health care facility "NZOZ Komed"
Study officials:
affiliation: Medical University of Lodz, Poland
name: Natalia Kociuga, master
role: PRINCIPAL_INVESTIGATOR
References: