UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044884 |
|---|---|
| Receipt number | R000050956 |
| Scientific Title | Effect of basic body awareness therapy on geriatric knee osteoarthritis patients with chronic pain and depression |
| Date of disclosure of the study information | 2021/07/17 |
| Last modified on | 2021/07/16 17:55:40 |
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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
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
victoryv2@yahoo.co.in
Sponsor or person
Institute
MGM College of Physiotherapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050956
