CTRI Number	CTRI/2018/01/011344 [Registered on: 15/01/2018] Trial Registered Retrospectively
Last Modified On:	19/11/2019
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Physiotherapy (Not Including YOGA)
Study Design	Single Arm Study
Public Title of Study Modification(s)	Modern Physiotherapeutic Methods in Humans
Scientific Title of Study	Evaluation of the Effectiveness of Modern Physiotherapeutic Methods in Selected Diseases
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Alina Wozniak  Address  Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland 85-092 Other  Phone  48525853740   Fax  48525853742   Email  alina-wozniak@wp.pl
Details Contact Person Scientific Query Modification(s)	Name  Pawel Sutkowy  Address  Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland 85-092 Other  Phone  48525853822   Fax  48525853742   Email  p.sutkowy@cm.umk.pl
Details Contact Person Public Query Modification(s)	Name  Pawel Sutkowy  Address  Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland 85-092 Other  Phone  485255853822   Fax  48525853742   Email  p.sutkowy@cm.umk.pl
Source of Monetary or Material Support	The Chair of Medical Biology, Nicolaus Copernicus University, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Poland
Primary Sponsor	Name  Ludwik Rydygier Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Torun Poland  Address  ul. Karlowicza 24, 95-092 Bydgoszcz, Poland  Type of Sponsor  Government medical college
Details of Secondary Sponsor	Name  Address  Centrum Rehabilitacji Funkcjonalnej Sielski Lukasz Piotr  ul. Jesionowa 11 85-149 Bydgoszcz Poland
Countries of Recruitment	Poland
Sites of Study	No of Sites = 2   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Lukasz Sielski  Centrum Rehabilitacji Funkcjonalnej Sielski Lukasz Piotr  ul. Jesionowa 11 85-149 Bydgoszcz Poland Not Applicable   48603851750 lsielski@wp.pl  Alina Wozniak  The Chair of Medical Biology Ludwik Rydygier Collegium Medicum in Bydgoszcz Poland  ul. Karlowicza 24 85-092 Bydgoszcz Poland Not Applicable   48525853737 kizbiolog@cm.umk.pl
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Bioethics Committee at Collegium Medicum in Bydgoszcz of Nicolaus Copernicus University in Toruń, Poland  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Supporting the treatment of injuries in sports and rehabilitation of patients  Patients  Unspecified multiple injuries
Intervention / Comparator Agent	Type  Name  Details  Intervention  Compression therapy  The therapy using a device with variable pressure - individually adapted to the needs of the patient. Duration of the procedure - several minutes.  Intervention  Electromagnetic field  Electromagnetic field is a kind of therapy using electrical current applied to the skin around the joints or to the whole body. The aim is to improve cellular metabolic processes and enzymatic activity, as well as accelerating lymph outflow from tissue with inflammatation. Details: high energy pulsed electromagnetic field - magnetic induction up to 3T, magnetic field frequency up to 100Hz, duration of treatment - up to 60 minutes.  Intervention  Extracorporeal shock wave therapy (ESWT)   The shock wave is generated under the pressure in a special apparatus and applied to the body in a form of impulses using special head. Thanks to this, the shock wave goes very precisely to a specific place. The aim is to improve cellular metabolic processes and enzymatic activity, as well as accelerating lymph outflow from tissue with inflammatation. Details: radial and focused shock waves: pressure up to 5 Bars, frequency up to 20Hz, number of hits up to 2000, duration of the procedure - a few minutes.  Intervention  functional therapy combined with biofeedback  It is a set of exercises on a stable or unstable/labile ground and/or treadmill to improve concentration, neuromuscular control, proprioception and lost motor functions.Physical exercise is an method supporting the treatment of injuries in sports and rehabilitation of patients. Especially innovative is a method using anti-gravity treadmill, which allows considerable weight reduction.  Intervention  High Intense Laser Therapy (HILT)  The method uses laser radiation, which is emitted with power exceeding 500mW. The aim is to improve cellular metabolic processes and enzymatic activity, as well as accelerating lymph outflow from tissue with inflammatation. Details: power up to 10W (continuous working) or 3kW (pulse working), treatment doses of 2-12J/cm2, laser exposure technique - static, point and/or surface, duration of the procedure - a few seconds to several minutes.  Comparator Agent  NOT APPLICABLE  NOT APPLICABLE
Inclusion Criteria	Age From  18.00 Year(s) Age To  80.00 Year(s) Gender  Both  Details  Individuals diagnosed by a physician with recommendation for appropriate therapy.
ExclusionCriteria	Details  Exclusion criteria: neoplastic diseases, myocardial infarction, surgery performed in the last six months, infectious (bacterial, viral) diseases, lack of contact with the patient - advanced dementia changes, no voluntary consent to the examination, bad feeling of the patient on the day of the study.
Method of Generating Random Sequence	Other
Method of Concealment	An Open list of random numbers
Blinding/Masking	Participant, Investigator and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Physical examination: a. physical examination (assessment of muscular strength and tension, joint mobility, assessment of maximum pain points), b. ultrasonography of diseased tissue, c. examination of surface muscle tension - electromyography, d. assessment of limb load and balance using stabilometric or dynamic platform.  Two study timepoints: before and after the 10-day therapy.
Secondary Outcome	Outcome  TimePoints  Examination of patients’ peripheral blood: - erythrocytic activity of superoxide dismutase, catalase and glutathione peroxidase, as well as the concentration of thiobarbituric acid reactive substances (TBARS) and conjugated dienes (CD) - plasma concentration of TBARS, CD, malondialdehyde and vitamins A and E. - serum activity of arylsulfatase, acid phosphatase, cathepsin D, alpha1-antitrypsin, interleukin-1β, interleukin-6, tumor necrosis factor alpha and tumor growth factor beta1.   Before the 10-day therapy, during the therapy (7 days from start of the study) and 4 days after the therapy completion (14 days from start of the study)
Target Sample Size	Total Sample Size="180" Sample Size from India="0"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	No Date Specified
Date of First Enrollment (Global)	03/09/2013
Estimated Duration of Trial	Years="2" Months="4" Days="12"
Recruitment Status of Trial (Global) Modification(s)	Completed
Recruitment Status of Trial (India)	Not Applicable
Publication Details Modification(s)	there is none yet
Brief Summary	The proposed research includes an interdisciplinary research project that will allow to draw conclusions about the degree of oxygen free radicals generation, the efficiency of antioxidant mechanisms and the occurrence of inflammatory processes in the body and their variability due to the action of various physical stimuli.