UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment effect of interventions using mechanical loading to people with primary complaint of knee pain
Title of the study (Brief title)	Three-arm randomized control trial of exercise intervention for the lumbar spine, exercise intervention for the knee and NSAID intervention for people with knee pain, whose Mechanical Diagnosis and Therapy subgroup of derangement syndrome in the lumbar spine
Region	Japan

Condition
Condition	People with primary complaint of knee pain, whose Mechanical Diagnosis and Therapy subgroup of derangement syndrome in the lumbar spine
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate weather individuals with knee pain, who respond to mechanical loading to the spine, do not respond to other interventions or not
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Global Rating Recovery Scale will be evaluated at 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the initial intervention.
Key secondary outcomes	Range of knee flexion/extension, the P4, the EQ-5D, the Patient Specific Functional Scale, and the Knee Injury and Osteoarthritis Outcome Score will be evaluated before the initial intervention and at 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the initial intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eight-week intervention with mechanical loading to the lumbar spine along with the directional preference
Interventions/Control_2	Four-week intervention with mechanical loading to the knee and then 4-week intervention with mechanical loading to the lumbar spine along with the directional preference
Interventions/Control_3	Four-week intervention with prescription of NSAID and then 4-week intervention with mechanical loading to the lumbar spine along with the directional preference
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Primary complain of knee pain lasting for more than one month Improvement of the knee by mechanical loading to the lumbar spine
Key exclusion criteria	Kellgren-Lawrence grade 4 Not being eligible to exercise therapy or manual therapy Purpose for post-surgical management Not being able to obtain a written consent from the participant
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Division of Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama, Japan
TEL	0489734706
Email	takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Division of Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama, Japan
TEL	0489734706
Homepage URL
Email	takasaki-hiroshi@spu.ac.jp

Sponsor
Institute	Saitama Prefectural University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Minami Shinjuku Orthopedic Clinic
Name of secondary funｄer(s)

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	2017 Year 06 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 31 Day
Anticipated trial start date	2017 Year 06 Month 23 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	2017 Year 06 Month 19 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031881