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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02934100
• Date of registration: 11/10/2016
• Prospective Registration: No
• Primary sponsor: Medical Universtity of Lodz
• Public title: Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
• Scientific title: Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
• Date of first enrolment: August 2016
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02934100
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Natalia Kociuga, master

• Name: Natalia Kociuga, master

• Name: Natalia Kociuga, master
• Affiliation: Medical University of Lodz, Poland

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Heel Spur

Calcaneal Spur

Intervention(s)

Device: Sham LASER CTL1106MX

Device: Shock Master 300

Device: EVO US13 CosmoGamma

Device: Skanlab 25 BODYWAVE

Primary Outcome(s)

The Laitinen Pain Indicator Questionnaire [Time Frame: 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 [Time Frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.]

The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change [Time Frame: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.]

Secondary Outcome(s)

Heel standing test [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.]

Two weights test [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.]

The Visual Analogue Scale [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.]

Secondary ID(s)

RNN/47/16/KE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors