Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001367932
Ethics application status
Approved
Date submitted
1/02/2020
Date registered
18/12/2020
Date last updated
18/12/2020
Date data sharing statement initially provided
18/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of nerve mobilization techniques and spinal traction in patients with back pain radiating into lower limbs
Scientific title
Effectiveness of neural mobilization with traction in the management of lumbar radiculopathy (ENMT Trial)
Secondary ID [1] 300233 0
Nil Known
Universal Trial Number (UTN)
U1111-1247-0631
Trial acronym
ENMT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar Radiculopathy 315945 0
Condition category
Condition code
Neurological 314213 314213 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neural Mobilization plus Lumbar Traction arm: participants in this group received 12 sessions of lumbar spine traction for up to 12 days followed by neural mobilizations. Traction was applied for 20 minutes duration with an intermittent force of 50 per cent of body weight. Each participant also received two types of mobilizing techniques: Static opener and two-end sliders. For applying static opener participants were instructed to lie on their side with painful side uppermost and hips and knee were flexed to 90, they were requested to move towards the edge of the treatment bed so that their knees protrude forward hand’s breadth over the side of the plinth. Then participants were advised to slowly drape their legs over the edge of the bed hence producing contralateral lateral flexion on the symptomatic side. They held this position for up to 1 minute and repeat it thrice during each session. For administering two-ended slider patients were instructed to sit straight on the treatment table with their legs hanging and holding arms at their back. For the first slider, they have to flex their neck from neutral position to full flexion simultaneously flexing their both knees. During the second slider, they had to extend their neck from neutral position simultaneously extending their both knees. Each technique was performed 10 times per session. Both types of mobilizing techniques were employed one after another after the application of traction. Treatment was delivered by physiotherapists who had at least 2 years of clinical experience and trained in applying neural mobilizations. Each participant was also required to provide data about their disability level (Oswestry Disability Questionnaire) and pain (Numeric Pain Rating Scale) before first treatment session and one day after the commencement of the last session. Treatment was provided at outpatient physiotherapy facility.
Intervention code [1] 316609 0
Treatment: Other
Intervention code [2] 316611 0
Rehabilitation
Comparator / control treatment
Lumbar Traction Alone arm: participants in this group received 12 sessions of lumbar spine traction only for up to 12 days. Traction was applied for 20 minutes duration with an intermittent force of 50 per cent of body weight. Treatment was delivered individually to each participant by physiotherapists who had at least 2 years of clinical experience. Each participant was also required to provide data about their disability level (Oswestry Disability Questionnaire) and pain (Numeric Pain Rating Scale) before first treatment session and one day after the commencement of the last session. Treatment was provided at outpatient physiotherapy facility.
Control group
Active

Outcomes
Primary outcome [1] 322596 0
Mean Disability Score assessed using the Oswestry Disability Index (ODI)
Timepoint [1] 322596 0
Baseline and next day post commencement of the intervention
Primary outcome [2] 322597 0
Radiating Lumbar Pain assessed using 11-point Numerical Pain Rating Scale (NPRS)
Timepoint [2] 322597 0
Baseline and next day post commencement of the intervention
Secondary outcome [1] 379012 0
Nil
Timepoint [1] 379012 0
Nil

Eligibility
Key inclusion criteria
*Participants between 20 and 70 years of age.
*Participants with a chief complaint of low back pain referred for physical therapy.
*Participants having pain radiating below the gluteal fold which reproduced radicular symptoms on Straight Leg Raise (SLR) test, Slump test, or Prone Knee Bend Test
*Participants having Oswestry Index score of greater than 10% at baseline.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients presenting with spinal conditions (e.g. infection, tumours, fractures, or osteoporosis)
*Patients who are pregnant.
*Patients with a history of previous spinal surgery.
*Patients with symptoms of Cauda Equina Syndrome.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2019
Date of last participant enrolment
Anticipated
Actual
29/10/2019
Date of last data collection
Anticipated
Actual
13/11/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 22252 0
Pakistan
State/province [1] 22252 0
Sind

Funding & Sponsors
Funding source category [1] 304663 0
Self funded/Unfunded
Name [1] 304663 0
Muhammad Saad Khan
Country [1] 304663 0
Pakistan
Funding source category [2] 305275 0
Hospital
Name [2] 305275 0
Jinnah Postgraduate Medical Centre (JPMC)
Country [2] 305275 0
Pakistan
Primary sponsor type
Individual
Name
Muhammad Saad Khan
Address
College of Physiotherapy, Jinnah Postgraduate Medical Centre, Rafiqui Sarwar Shaheed Road, Karachi Cantonment, Karachi, Sindh 75510
Country
Pakistan
Secondary sponsor category [1] 304967 0
None
Name [1] 304967 0
Address [1] 304967 0
Country [1] 304967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305083 0
Institutional Ethical Review Committee of Isra Institute of Rehabilitation Sciences, Isra University, Karachi Campus
Ethics committee address [1] 305083 0
Ethics committee country [1] 305083 0
Pakistan
Date submitted for ethics approval [1] 305083 0
Approval date [1] 305083 0
01/11/2018
Ethics approval number [1] 305083 0
IERC/IIRS-IU-KC/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99210 0
Dr Muhammad Saad Khan
Address 99210 0
College of Physiotherapy, Jinnah Postgraduate Medical Centre, Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Sindh 75510
Country 99210 0
Pakistan
Phone 99210 0
+922199201300
Fax 99210 0
Email 99210 0
[email protected]
Contact person for public queries
Name 99211 0
Muhammad Saad Khan
Address 99211 0
College of Physiotherapy, Jinnah Postgraduate Medical Centre, Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Sindh 75510
Country 99211 0
Pakistan
Phone 99211 0
+922199201300
Fax 99211 0
Email 99211 0
[email protected]
Contact person for scientific queries
Name 99212 0
Muhammad Saad Khan
Address 99212 0
College of Physiotherapy, Jinnah Postgraduate Medical Centre, Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Sindh 75510
Country 99212 0
Pakistan
Phone 99212 0
+922199201300
Fax 99212 0
Email 99212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.