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

Medical University of Lodz

Status: Unknown

Conditions: Heel Spur; Calcaneal Spur

Treatments: Device: Shock Master 300; Device: Sham LASER CTL1106MX; Device: EVO US13 CosmoGamma; Device: Skanlab 25 BODYWAVE

Study type: Interventional

Funder types: Other

Identifiers

NCT02934100

RNN/47/16/KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

120 participants in 4 patient groups

Group 1 - ESWT Treatment

Active Comparator group

Description:

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

Treatment:

Device: Shock Master 300

Group 2 - Body Wave

Active Comparator group

Description:

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

Treatment:

Device: Skanlab 25 BODYWAVE

Group 3 - Ultrasound

Active Comparator group

Description:

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

Treatment:

Device: EVO US13 CosmoGamma

Group 4 - Control group

Sham Comparator group

Description:

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

Treatment:

Device: Sham LASER CTL1106MX