UMIN-CTR Clinical Trial

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050933