Low Back PainNCT05059249

Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.

A study testing Hot Pack, Manual Traction and Mechanical Traction in people with Low Back Pain and Low Back Pain, Mechanical, run by Foundation University Islamabad at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain, Low Back Pain, Mechanical, Disc Degeneration
What is being tested?: Hot Pack, Manual Traction and Mechanical Traction
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 sitePakistan
Study dates: 1 Mar 2019to 30 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients with discogenic low back pain,
Patients of both genders
Age ranges from 20 to 60 years
NPRS > 5

Who cannot join

Patients with non-mechanical back pain
Patients with known metabolic diseases,
Osteoporotic patients,
Recent history of spinal trauma or surgery,
Lumbar myelopathy,
Cauda equine syndrome.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000

Other trials in Pakistan

About this study

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain

Conditions: Low Back Pain, Low Back Pain, Mechanical, Disc Degeneration, Disc Prolapse, Disc Prolapse With Radiculopathy, Lumbar Radiculopathy
Being tested: Hot Pack, Manual Traction, Mechanical Traction, Joint Mobilization, TENS
Medical subject headings: Low Back Pain, Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hot PackProcedure or surgery
Superficial Heating
Manual TractionProcedure or surgery
Manual Traction for 10 minutes
Mechanical TractionProcedure or surgery
Mechanical Traction for 10 minutes
Joint MobilizationProcedure or surgery
3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions
TENSProcedure or surgery
TENS for 10 minutes with hot pack

Study groups in NCT05059249
Study group	Role	What they receive
Manual Traction	Experimental	Moist heat packs \& TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient. Receives: Procedure: Hot Pack; Procedure: Manual Traction; Procedure: Joint Mobilization; Procedure: TENS
Mechanical traction	Experimental	Moist heat packs \& TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient Receives: Procedure: Hot Pack; Procedure: Mechanical Traction; Procedure: Joint Mobilization; Procedure: TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric Pain Rating Scale
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.
Measured: 6 weeks
Oswestry disability index
Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201930 Jan 2020

First posted28 Sep 2021
Study start1 Mar 2019
Primary completion30 Dec 2019
Study completion30 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Foundation University IslamabadThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05059249
Sponsor's protocol ID: FUI/CTR/2021/5
Status last verified: Sep 2021
First submitted: 17 Sep 2021
Last updated: 28 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
ClinicalTrials.gov ID: NCT05059249
Acronym / sponsor ID: FUI/CTR/2021/5
Conditions: Low Back Pain, Low Back Pain, Mechanical, Disc Degeneration, Disc Prolapse, Disc Prolapse With Radiculopathy, Lumbar Radiculopathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Foundation University IslamabadUniversity, hospital or other
Study start: 1 Mar 2019 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 28 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Manual Traction	Experimental	Procedure: Hot Pack, Procedure: Manual Traction, Procedure: Joint Mobilization, Procedure: TENSMoist heat packs \& TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient.
Mechanical traction	Experimental	Procedure: Hot Pack, Procedure: Mechanical Traction, Procedure: Joint Mobilization, Procedure: TENSMoist heat packs \& TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients with discogenic low back pain,
Patients of both genders
Age ranges from 20 to 60 years
NPRS > 5

Key exclusion criteria (6 listed)

Patients with non-mechanical back pain
Patients with known metabolic diseases,
Osteoporotic patients,
Recent history of spinal trauma or surgery,
Lumbar myelopathy,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hot PackSuperficial Heating	Procedure or surgery	Manual Traction, Mechanical traction
Manual TractionManual Traction for 10 minutes	Procedure or surgery	Manual Traction
Mechanical TractionMechanical Traction for 10 minutes	Procedure or surgery	Mechanical traction
Joint Mobilization3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions	Procedure or surgery	Manual Traction, Mechanical traction
TENSTENS for 10 minutes with hot pack	Procedure or surgery	Manual Traction, Mechanical traction

Primary outcome

Numeric Pain Rating Scale
Time frame: 6 weeks
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.
Oswestry disability index
Time frame: 6 weeks
Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Furqan Yaqoob, PhD* principal investigator

Foundation University Islamabad

Muhammad Osama, PhD* principal investigator

Foundation University Islamabad

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hot Pack, Manual Traction and Mechanical Traction in people with Low Back Pain and Low Back Pain, Mechanical, run by Foundation University Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05059249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.