Prolapsed Intervertebral DiscNCT04728685
Effects of Lumbar Traction on the Straight Leg Raise Test and Pain
A study testing Mechanical Traction in people with Prolapsed Intervertebral Disc, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Prolapsed Intervertebral Disc
- What is being tested?
- Mechanical Traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Jan 2021to 24 Mar 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Back pain for less than 3 months
- Positive unilateral Straight Leg Raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion
- At least one additional neurological sign should be present including- (a) Diminished Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome.
- MRI evidence of L-4-L5 or L5-S1 disc prolapse or both.
Who cannot join
- Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column
- Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper mobility
- Subjects who could not tolerate the traction force secondary to being in an acute stage of back pain.
- Subjects who have taken previous physiotherapy treatment in the last three months for back pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of One-fifth, One-third, and One-half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients
Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. So the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.
Read the detailed description
A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided into three groups with 15 participants in each group. group A. for one-fifth of body weight traction, group b for one-third of body weight traction, and group C for one-half of body weight traction. SLR and pain will be measured before traction and after traction. A goniometer will be used to measure SLR and VAS will be used to measure pain.
- Conditions
- Prolapsed Intervertebral Disc
- Being tested
- Mechanical Traction
- Keywords
- Mechanical Traction, Prolapsed intervertebral disc, straight leg raise test, pain
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical TractionProcedure or surgery
Mechanical Traction will be applied to the lumbar region using a traction unit.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | One-fifth of body weight traction force will be given Receives: Procedure: Mechanical Traction |
| Group B | Active comparator | One-third of body weight traction force will be given Receives: Procedure: Mechanical Traction |
| Group C | Active comparator | One-half of body weight traction force will be given Receives: Procedure: Mechanical Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straight Leg Raise test
Straight leg raise test is used in supine position to test neurological signs
Measured: upto 1 month
Visual analog scale
Visual analog scale is used to measure pain. This scale has 0 to 10 points, 0 being no pain and 10 means maximum pain someone has felt. Higher the score worse is the condition.
Measured: upto 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start25 Jan 2021
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapsed Intervertebral DiscStudies of the same condition, open and under way.
- 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
- Model description
- Three-arm parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, MPTh, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728685
- Sponsor's protocol ID
- RRC-2019-29
- Status last verified
- Aug 2021
- First submitted
- 24 Jan 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of One-fifth, One-third, and One-half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients
- ClinicalTrials.gov ID
- NCT04728685
- Acronym / sponsor ID
- RRC-2019-29
- Conditions
- Prolapsed Intervertebral Disc
- Keywords
- Mechanical Traction, Prolapsed intervertebral disc, straight leg raise test, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 28 Jan 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.
Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. So the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.
Detailed description
A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided into three groups with 15 participants in each group. group A. for one-fifth of body weight traction, group b for one-third of body weight traction, and group C for one-half of body weight traction. SLR and pain will be measured before traction and after traction. A goniometer will be used to measure SLR and VAS will be used to measure pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel groups
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Mechanical TractionOne-fifth of body weight traction force will be given |
| Group B | Active comparator | Procedure: Mechanical TractionOne-third of body weight traction force will be given |
| Group C | Active comparator | Procedure: Mechanical TractionOne-half of body weight traction force will be given |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Back pain for less than 3 months
- Positive unilateral Straight Leg Raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion
- At least one additional neurological sign should be present including- (a) Diminished Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome.
- MRI evidence of L-4-L5 or L5-S1 disc prolapse or both.
Key exclusion criteria (4 listed)
- Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column
- Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper mobility
- Subjects who could not tolerate the traction force secondary to being in an acute stage of back pain.
- Subjects who have taken previous physiotherapy treatment in the last three months for back pain.
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 |
|---|---|---|
| Mechanical TractionMechanical Traction will be applied to the lumbar region using a traction unit. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
Straight Leg Raise test
Time frame: upto 1 month
Straight leg raise test is used in supine position to test neurological signs
Visual analog scale
Time frame: upto 1 month
Visual analog scale is used to measure pain. This scale has 0 to 10 points, 0 being no pain and 10 means maximum pain someone has felt. Higher the score worse is the condition.
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 31 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Masood Khan, MPTh principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Traction in people with Prolapsed Intervertebral Disc, run by King Saud University at 1 site in Saudi Arabia.
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 4 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 31 Aug 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 Saudi Arabia. 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?
Straight Leg Raise test (time frame: upto 1 month). 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?
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 31 Aug 2021.