UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014866 |
|---|---|
| Receipt number | R000017283 |
| Scientific Title | The effect of a single session of manual therapy on the peripheral arteries blood flow in patients after fast-track TKA: a pilot study. |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2014/08/15 01:50:50 |
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Basic information
Public title
The effect of a single session of manual therapy on the peripheral arteries blood flow in patients after fast-track TKA: a pilot study.
Acronym
Manual therapy and blood flow
Scientific Title
The effect of a single session of manual therapy on the peripheral arteries blood flow in patients after fast-track TKA: a pilot study.
Scientific Title:Acronym
Manual therapy and blood flow
Region
| Europe |
Condition
Condition
Osteoarthritis, manual therapy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify the underlying mechanisms of manual therapy and to examine the effects of selected manual therapeutic interventions on blood flow rate in popliteal artery and saphenous branch of descending genicular artery using color Doppler ultrasonography in patients undergoing TKA before and after manual therapy treatment session.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1) blood flow, 2) artery diameter, 3) peak blood flow velocity in popliteal, tibial and saphena arteries preoperatively and after surgery and manual session
Key secondary outcomes
association with preoperative anxiety
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Questionnaires assessing level of preoperational anxiety were administered during interviews and were completed the same day by all patients.
single manual therapy session
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were eligible for the study if they had Kellgren and Lawrence radiographic stage III and IV primary osteoarthrosis, 18 to 80 years old, and operated on by the same surgeon
Key exclusion criteria
Patients were excluded if they had systemic or metabolic disorders, rheumatoid arthritis, previous major surgery on the affected joint (e.g. TKA, arthrotomy, operated tibial plateau fracture, proximal tibial osteotomy), peripheral vascular disease (ankle-brachial index < 0.40) or known stenosis of the lower extremity vessels, neurologic or psychiatric disease, or alcohol abuse.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University in Szczecin
Division name
Pomeranian Medical University in Szczecin
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
48914253238
paulz@wp.pl
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University in Szczecin
Division name
Pomeranian Medical University in Szczecin
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
48914253238
Homepage URL
paulz@wp.pl
Sponsor or person
Institute
Zietek
Institute
Department
Personal name
Funding Source
Organization
Own
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 15 | Day |
Last modified on
| 2014 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017283
