NCT02934100

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heel Spur
• Calcaneal Spur

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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
DEVICE	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
DEVICE	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

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2018-06-01
• First posted: 2016-10-14
• Last updated: 2016-10-14

Locations

1 site across 1 country: Poland