UMIN-CTR Clinical Trial

Basic information
Public title	Effect of basic body awareness therapy on geriatric knee osteoarthritis patients with chronic pain and depression
Acronym	Basic body awareness therapy - effects in Geriatric patients
Scientific Title	Effect of basic body awareness therapy on geriatric knee osteoarthritis patients with chronic pain and depression
Scientific Title:Acronym	Basic body awareness therapy - effects in Geriatric patients
Region	Asia(except Japan)

Condition
Condition	Osteoarthritis of Knee, chronic pain and depression
Classification by specialty	Medicine in general Geriatrics Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effects of basic body awareness therapy on chronic pain and depression in older adults with knee osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain was assessed using Numeric Pain rating scale and depression using Montgomery-Asberg depression rating scale
Key secondary outcomes	Level of body awareness was assessed by revised body awareness rating questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Conventional Therapy included acute care management, functional restorative management and preventive management. The exercises were supervised by a physiotherapist, twice a week for 5 weeks.
Interventions/Control_2	Basic body awareness therapy consisted of breathing and concentration, movement, balance and posture, self massage and relaxation along with conventional exercises. These exercises were carried out supervised by a physiotherapist for 2 days a week for 5 weeks.
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	60 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with chronic pain with knee osteoarthritis reporting to the Physiotherapy Out patient department. Patients with having mild to moderate depression
Key exclusion criteria	Patients unwilling to participate, on anti-depressants, patients reporting severe and acute pain, patients with severe depression, patients with any neurological conditions and patients with any unstable cardiovascular conditions.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Vijaya Middle name Last name Krishnan
Organization	MGM College of Physiotherapy
Division name	Navi Mumbai
Zip code	400705
Address	Sanpada, Navi Mumbai
TEL	9920029213
Email	victoryv2@yahoo.co.in

Public contact
Name of contact person	1st name Vijaya Middle name Last name Krishnan
Organization	MGM College of Physiotherapy
Division name	Navi Mumbai
Zip code	400705
Address	Sanpada, Navi Mumbai
TEL	9920029213
Homepage URL
Email	victoryv2@yahoo.co.in

Sponsor
Institute	MGM College of Physiotherapy
Institute
Department

Funding Source
Organization	Nil
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	MGM College of Physiotherapy
Address	Navi Mumbai
Tel	9920029213
Email	victoryv2@yahoo.co.in

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	2021 Year 07 Month 17 Day

Related information
URL releasing protocol	Data available on request
Publication of results	Unpublished

Result
URL related to results and publications	-
Number of participants that the trial has enrolled	50
Results	Both therapies were effective for pain management. Basic body awareness therapy as an adjunct to conventional therapy was found to be more effective in reducing depression in older adults.
Results date posted	2021 Year 07 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Elderly osteoarthritis knee patients were randomly allocated to two groups with 25 patients in each group. The mean age of the participant were 66.5 years.
Participant flow	Written informed consent was obtained from the participants. Then they were screened based on the criteria and allocated to the two groups randomly and with an intent to treat.
Adverse events	No adverse events were reported
Outcome measures	Numerical Pain Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRS) and Body Awareness Rating Questionnaire (BARQ)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 23 Day
Date of IRB	2019 Year 04 Month 28 Day
Anticipated trial start date	2019 Year 08 Month 21 Day
Last follow-up date	2020 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 16 Day
Last modified on	2021 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050956