UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044592 |
|---|---|
| Receipt number | R000050933 |
| Scientific Title | Comparison between tele-rehabilitation and face to face rehabilitation in patients with chronic mechanical low back pain. |
| Date of disclosure of the study information | 2021/06/19 |
| Last modified on | 2021/06/18 18:38:35 |
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Basic information
Public title
Comparison between tele-rehabilitation and face to face rehabilitation in patients with chronic mechanical low back pain.
Acronym
Tele-rehabilitation and Chronic low back pain
Scientific Title
Comparison between tele-rehabilitation and face to face rehabilitation in patients with chronic mechanical low back pain.
Scientific Title:Acronym
Tele-rehabilitation and Chronic low back pain
Region
| Asia(except Japan) |
Condition
Condition
Chronic Low Back Pain
Classification by specialty
| Medicine in general | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine an efficient treatment protocol for rehabilitation of chronic low back pain patients with respect to pain and functional disability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale (NRS)and Modified Oswestry Low Back Pain Disability Questionnaire were used to measure Pain and Functional Disability at baseline, after 2 weeks and after 4 weeks of intervention
Key secondary outcomes
Modified Schober's Test was used to measure Mobility of the Lumbar Spine at baseline, after 2 weeks and after 4 weeks of intervention
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
| Device,equipment | Maneuver |
Interventions/Control_1
Face to Face conventional Therapy which included Exercises which were conducted under the supervision of a Physiotherapist 3 days a week, continued for 4 weeks. Exercises were progressed weekly.
Interventions/Control_2
Tele-rehabilitation which included Exercises which were conducted under the supervision of a Physiotherapist 3 days a week, continued for 4 weeks. Exercises were conducted remotely via Zoom cloud meeting app and were progressed weekly.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic mechanical low back pain reporting to the Physiotherapy Outpatient Department.
Key exclusion criteria
Patients with severe pain with a score of 8 and above on Numerical Pain rating scale, Patients with acute low back pain, patients with any infective or inflammatory low back pain and patients with neurological dysfunction and recent injuries.
Target sample size
40
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 | 06 | Month | 19 | 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
40
Results
Both the protocols showed statistically significant improvement for both pain, mobility and functional disability. However, Tele-rehabilitation was more effective with respect to Pain and functional disability in patients with chronic low back pain
Results date posted
| 2021 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic low back pain patients were randomly allocated to two with 20 patients in each group. Mean age was 32.52 with 15 males and 25 females
Participant flow
Participants gave written informed consent followed by screening with respect to inclusion/exclusion criteria and then allocated to two groups. They were recruited with intent to treat
Adverse events
No adverse events were reported
Outcome measures
Numerical Pain Rating Scale, Modified Oswestry Low Back Pain Disability Questionnaire and Modified Schober's Test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 05 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050933
