Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000589583
Ethics application status
Approved
Date submitted
13/05/2023
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Date results information initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of spinal traction with oxygen therapy in patients with lumbar disc problems.
Scientific title
Effects of spinal decompression with and without oxygen therapy in patients with lumbar disc protrusion, a randomized controlled trial
Secondary ID [1] 308677 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar Disc protrusion/herniation 328604 0
Condition category
Condition code
Musculoskeletal 325615 325615 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment was given for 2 weeks with 4 number of session (2 sessions a week). The treatment was given by a team of Physiotherapist. The sequence of treatment session was given as below:
1. Transcutaneous electric nerve stimulation was applied in prone lying position on treatment table. Four electrodes were placed at lower back region at the site of pain parallel to lumbar spine. TENS applied with 4 electrodes and maximum output supplied with 200 Hz for 10 minutes. Intensity of both channels is adjustable from level one to level nine. Intensity was set according to patient comfort
2. WHF-312 infrared lamp model was used for Infrared therapy, applied in continuous mode for 10 minutes. Intensity and height of lamp was adjusted according to patient comfort.
3. Treadmill walk was done by patient for 10 minutes at comfortable pace before decompression therapy and it was use to assess the patient capability to walk for how many minutes without pain and numbness.
4. Neuro-oxy motorized lumbar spinal decompression therapy with Oxygen therapy was applied with a session of 25 minutes. An adjustable specialized form of split table was used to decompress the spine by pulling the vertebrae apart. Patient was lying in spine position pelvic and thoracic harness fasten for stabilization. Split table has a fixed and (lower end) moveable part. Lumbar spine was placed between the fix and moveable part of split table. A wedge was placed under patient knees. Decompression was applied at the level of disc bulge confirmed by MRI. Legacy 6 was applied which is most relaxing as it has 30 seconds hold and 20 seconds relax time. Nasal canola was used for oxygen treatment and 4 liters per minute of oxygen was delivered to patient during decompression.
5. Shortwave diathermy applied at lumbar region in prone position for 10 minutes. Pulse width was adjusted at 200-400 µs and pulse rate 400-800 pulse per second. Intensity was adjusted according to patient comfort level.
Intervention code [1] 325148 0
Rehabilitation
Comparator / control treatment
Control group exposed with the spinal decompression therapy, transcutaneous electric nerve stimulation, infrared heat and shortwave diathermy. No oxygen therapy administered in control group
Control group
Active

Outcomes
Primary outcome [1] 333455 0
Modified Oswestry disability index was used to assess the disability index and functional status of patient due to lumbar disc protrusion,
Timepoint [1] 333455 0
Base line and 4th visit after commencing treatment
Primary outcome [2] 333456 0
Numeric pain rating scale was used to assess the pain intensity.
Timepoint [2] 333456 0
Base line and 4th visit after commencing treatment
Primary outcome [3] 335265 0
10 minutes treadmill walk test was done for assessing the capability of patient to walk without pain and numbness.
Timepoint [3] 335265 0
1st visit and 4th visit after commencing treatment
Secondary outcome [1] 417152 0
Nil
Timepoint [1] 417152 0
Nil

Eligibility
Key inclusion criteria
Diagnosed with lumbar disc bulge/protrusion.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lumbar spondylolisthesis, spinal stenosis, fracture of lumbar spine, spinal tumor, ankylosing spondylitis, patients taking blood thinner medication, inflammatory arthritis, rheumatologic and other autoimmune conditions.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss method
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated by OpenEpi version 3. was 18.
This study had total 72 participants which were divided into 2 groups, 36 for each group in experimental and control group.
SPSS was used for statistic analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/06/2017
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
14/08/2017
Sample size
Target
80
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 25194 0
Pakistan
State/province [1] 25194 0
Punjab

Funding & Sponsors
Funding source category [1] 312911 0
University
Name [1] 312911 0
Riphah International University
Country [1] 312911 0
Pakistan
Funding source category [2] 314200 0
Other
Name [2] 314200 0
KKT Orthopedic Spine Center,
Country [2] 314200 0
Pakistan
Primary sponsor type
University
Name
Riphah College of Rehabilitation Sciences, Riphah International University
Address
Gulberg green Service Rd, Block D Islamabad, Islamabad Capital Territory, postal code 44600.
Country
Pakistan
Secondary sponsor category [1] 314589 0
None
Name [1] 314589 0
Address [1] 314589 0
Country [1] 314589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312185 0
Research Ethical Committee, Riphah College of Rehabilitation sciences.
Ethics committee address [1] 312185 0
Riphah College of Rehabilitation sciences, Gulberg green Service Rd, Block D Islamabad, Islamabad Capital Territory, postal code 44600.
Ethics committee country [1] 312185 0
Pakistan
Date submitted for ethics approval [1] 312185 0
Approval date [1] 312185 0
01/08/2017
Ethics approval number [1] 312185 0
Riphah/RCRS/REC/00235

Summary
Brief summary
The purpose of study is to find out the effects of spinal decompression therapy with oxygen therapy in patients with lumbar disc protrusion in improving pain and function. .Oxygen therapy and manual spinal traction can be used together to provide a more comprehensive treatment for disc protrusion pathology.
Trial website
Trial related presentations / publications
Public notes
This study was as by requirement for Masters program degree in the Institute. Ethical approval was done before data collection by Ethical approval committee. No study can be organise without synopses, which was also in consideration and directions of research Ethical committee. The official detailed signed ethical approval letter became late due to official matters and we have time constraints for study.

Contacts
Principal investigator
Name 123774 0
Dr Muhammad Fawad
Address 123774 0
The Superior University Lahore, Faisalabad campus 2 Km from Khanuana bypass, satiana Road Faisalabad. Postal address 38000.
Country 123774 0
Pakistan
Phone 123774 0
+923215185561
Fax 123774 0
Email 123774 0
mfawad1@hotmail.com
Contact person for public queries
Name 123775 0
Mr Muhammad Fawad
Address 123775 0
The Superior University Lahore, Faisalabad campus 2 Km from Khanuana bypass, satiana Road Faisalabad. Postal address 38000.
Country 123775 0
Pakistan
Phone 123775 0
+923215185561
Fax 123775 0
Email 123775 0
muhamamd.fawwad@superior.edu.pk
Contact person for scientific queries
Name 123776 0
Prof Abdul Ghafoor Sajjad
Address 123776 0
Shifa Tameer e millat University Pitrus Bukhari road Road H-8/4 Islamabad 44000, Pakistan.
Country 123776 0
Pakistan
Phone 123776 0
+923335468034
Fax 123776 0
Email 123776 0
Abdulghafoorsajjad@gmail.com

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17943Ethical approval https://drive.google.com/drive/folders/1XT1ZdhhaHoJ-x4YSciM9a5dYHTB0Crce?usp=sharingfawaddar1@gmail.com 385179-(Uploaded-29-12-2022-05-14-16)-Study-related document.pdf
17944Informed consent form  fawaddar1@gmail.com 385179-(Uploaded-29-12-2022-05-17-18)-Study-related document.pdf
17945Other    Consent for data collection 385179-(Uploaded-29-12-2022-05-09-08)-Study-related document.pdf



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.