UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Extra-articular knee pain and efficacy of tender-point stretching
Title of the study (Brief title)	Extra-articular knee pain and efficacy of tender-point stretching
Region	Japan

Condition
Condition	Osteoarthritis (OA)
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(Phase 1) Confirm extra-articular pain is the mechanism for refractory pain resisted to standard treatments in OA knees. Examine and clarify anatomical points of extra-articular pain. (Phase 2) Prove extra-articular pain is improved significantly by stretching the anatomical points of tenderness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	(Phase 1) Physical findings and patient-based subjective assessment before and after intra-articular hyaluronic acid injection. (Phase 1) Physical findings and patient-based subjective assessment before and 3 months after intervention.
Key secondary outcomes	(Phase 1) Radiographic findings (Phase 1) Simple patient-based subjective assessment 1.5 months after intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	(Phase 2a) Tender-point stretching 3 times a week on an outpatient basis.
Interventions/Control_2	(Phase 2a) Ultrasound stimulation 3 times a week on an outpatient basis.
Interventions/Control_3	(Phase 2b) Instruction for tender-point stretching at outpatient department and self-execution twice a day, 5 minutes each time.
Interventions/Control_4	(Phase 2b) Self application of idometacin cream twice a day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with knee pain resisted to conventional conservative treatments for more than 3 months.
Key exclusion criteria	No minor is included. Patients with cognitive impairment and auditory disorder are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	Hideyuki Koga
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-4020
Email	koga.orj@tmd.ac.jp

Public contact
Name of contact person	Toshifumi Watanabe
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4020
Homepage URL
Email	watanabe.orj@tmd.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	1899
Org. issuing International ID_1	Faculty of Medicine, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科歯科大学医学部附属病院（東京都） Tokyo Medical and Dental University Hospital of Medicine

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 14 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018798