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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lumbar Disc protrusion/herniation

Condition category

Condition code

Musculoskeletal

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]

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]

Modified Oswestry disability index was used to assess the disability index and functional status of patient due to lumbar disc protrusion,

Timepoint [1]

Base line and 4th visit after commencing treatment

Primary outcome [2]

Numeric pain rating scale was used to assess the pain intensity.

Timepoint [2]

Base line and 4th visit after commencing treatment

Primary outcome [3]

10 minutes treadmill walk test was done for assessing the capability of patient to walk without pain and numbness.

Timepoint [3]

1st visit and 4th visit after commencing treatment

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Punjab

Funding & Sponsors

Funding source category [1]

University

Name [1]

Riphah International University

Address [1]

Gulberg green Service Rd, Block D Islamabad, Islamabad Capital Territory, postal code 44600.

Country [1]

Pakistan

Funding source category [2]

Other

Name [2]

KKT Orthopedic Spine Center,

Address [2]

Jahangir Multiplex, Adj. Quaid-e-Azam International Hospital, Main Peshawar, Road, H-13, Rawalpindi, Islamabad Capital Territory 46000

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethical Committee, Riphah College of Rehabilitation sciences.

Ethics committee address [1]

Riphah College of Rehabilitation sciences, Gulberg green Service Rd, Block D Islamabad, Islamabad Capital Territory, postal code 44600.

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

Approval date [1]

01/08/2017

Ethics approval number [1]

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

Dr Muhammad Fawad

Address

The Superior University Lahore, Faisalabad campus 2 Km from Khanuana bypass, satiana Road Faisalabad. Postal address 38000.

Country

Pakistan

Phone

+923215185561

Fax

mfawad1@hotmail.com

Contact person for public queries

Name

Muhammad Fawad

Address

The Superior University Lahore, Faisalabad campus 2 Km from Khanuana bypass, satiana Road Faisalabad. Postal address 38000.

Country

Pakistan

Phone

+923215185561

Fax

muhamamd.fawwad@superior.edu.pk

Contact person for scientific queries

Name

Abdul Ghafoor Sajjad

Address

Shifa Tameer e millat University Pitrus Bukhari road Road H-8/4 Islamabad 44000, Pakistan.

Country

Pakistan

Phone

+923335468034

Fax

Abdulghafoorsajjad@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No available source and confidential

What supporting documents are/will be available?

Doc. No.	Type	Link	Email	Other Details	Attachment
17943	Ethical approval	https://drive.google.com/drive/folders/1XT1ZdhhaHoJ-x4YSciM9a5dYHTB0Crce?usp=sharing	fawaddar1@gmail.com		385179-(Uploaded-29-12-2022-05-14-16)-Study-related document.pdf
17944	Informed consent form		fawaddar1@gmail.com		385179-(Uploaded-29-12-2022-05-17-18)-Study-related document.pdf
17945	Other			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.

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