Non-specific Low Back PainL&PtracinLBPNCT05518552
Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain
A study testing Manual lumbar traction and Prone traction in people with Non-specific Low Back Pain, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial summary
The study determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Manual lumbar traction and Prone traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNigeria
- Study dates
- 25 Jan 2019to 12 Feb 2022
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants diagnosed with Non-Specific Low Back Pain of not less than 3 months duration who were referred by a physician.
- Participants between the ages of 40 years and older.
Who cannot join
- Low back pain patients with specific pathology, such as systemic inflammatory diseases, pregnancy, fractures of the spine, tumors, infections.
- Participants with pathology affecting the trunk or upper and lower extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Manual Lumbar and Prone Traction on Clinical Variables in Patients With Non-specific Low Back Pain: A Randomized Control Study
The study determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain.
Read the detailed description
Traction therapy has been used in the management of low back pain (LBP) especially None Specific Low Back Pain. There are several recommendations on how lumbar traction should be performed, but the type of technique to be applied differs among the sources. Prone traction adapted from inversion therapy which is a form of gravitational traction has been reported to be effective in ameliorating disabilities of patients with low back pain as well reduce pain intensity. Manual lumbar traction is performed by the therapist, pulling at the patient's ankles and has been reported to be effective in relieving pain and reducing disability of patient with None Specific Low Back Pain (NSLBP). Documented evidences on the efficacy of traction in non-specific low back pain are still inconclusive. While manual lumbar traction seems more commonly used, probably owing to its positional advantage, its relative effectiveness compared with manual prone traction is still unknown, hence this study. Therefore, the aim of this study was to examine the efficacy of manual lumbar traction and prone traction on pain intensity, disability, spinal range of motion and quality of life in patients with None Specific Low Back Pain.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Manual lumbar traction, Prone traction
- Keywords
- Manual Lumbar Traction, Prone Traction, Pain Intensity, Low back pain, Disability
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lumbar tractionOther
Patient in the group were treated with manual traction
Prone tractionOther
Patient in the group were placed on prone traction
| Study group | Role | What they receive |
|---|---|---|
| manual Lumbar Traction | Experimental | The subjects consist of 25 patients with chronic low back pain. They underwent a manual lumbar traction with Physiotherapist pulling the patients while lying prone on a couch Receives: Other: Manual lumbar traction |
| Prone traction | Experimental | This group consist of patients with non specific chronic low back pain that were put on prone traction. Receives: Other: Prone traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale
It measure pain intensity: 0 which is no pain to 10 which is excruciating pain
Measured: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Secondary outcomes (2)
Roland Morris low back pain Disability questionnaire
It measures the disability of the patients from 0, no disability to 24 which is the greatest disability
Measured: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Goniometer
It measures spinal flexibility in "degree". The flexibility may start from 0 degree and the maximum depends on the flexibility of each participants
Measured: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start25 Jan 2019
- Primary completion18 Dec 2019
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies 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
- The group underwent manual lumbar traction with the patient lying prone on a couch using a manual technique by pulling from the ankles of the patient. Manual traction was performed by the therapist, pulling at the patient's ankles.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
- Investigators
- Adesola O Ojoawo, PhD, Principal investigator, Obafemi Awolowo University Ile Ife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518552
- Sponsor's protocol ID
- Ojo/2022/01
- Acronym
- L&PtracinLBP
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are kept with the principal investigator. Whosoever is interested can contact him for information
Publications
Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol. 2004 Mar;57(3):268-76. doi: 10.1016/j.jclinepi.2003.09.005.
PubMed 15066687Ozaktay AC, Cavanaugh JM, Asik I, DeLeo JA, Weinstein JN. Dorsal root sensitivity to interleukin-1 beta, interleukin-6 and tumor necrosis factor in rats. Eur Spine J. 2002 Oct;11(5):467-75. doi: 10.1007/s00586-002-0430-x. Epub 2002 Jun 4.
PubMed 12384756
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Lumbar and Prone Traction on Clinical Variables in Patients With Non-specific Low Back Pain: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05518552
- Acronym / sponsor ID
- L&PtracinLBP / Ojo/2022/01
- Conditions
- Non-specific Low Back Pain
- Keywords
- Manual Lumbar Traction, Prone Traction, Pain Intensity, Low back pain, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 26 Aug 2022 (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.
The study determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain.
Detailed description
Traction therapy has been used in the management of low back pain (LBP) especially None Specific Low Back Pain. There are several recommendations on how lumbar traction should be performed, but the type of technique to be applied differs among the sources. Prone traction adapted from inversion therapy which is a form of gravitational traction has been reported to be effective in ameliorating disabilities of patients with low back pain as well reduce pain intensity. Manual lumbar traction is performed by the therapist, pulling at the patient's ankles and has been reported to be effective in relieving pain and reducing disability of patient with None Specific Low Back Pain (NSLBP). Documented evidences on the efficacy of traction in non-specific low back pain are still inconclusive. While manual lumbar traction seems more commonly used, probably owing to its positional advantage, its relative effectiveness compared with manual prone traction is still unknown, hence this study. Therefore, the aim of this study was to examine the efficacy of manual lumbar traction and prone traction on pain intensity, disability, spinal range of motion and quality of life in patients with None Specific Low Back Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The group underwent manual lumbar traction with the patient lying prone on a couch using a manual technique by pulling from the ankles of the patient. Manual traction was performed by the therapist, pulling at the patient's ankles.
| Arm | Type | Receives |
|---|---|---|
| manual Lumbar Traction | Experimental | Other: Manual lumbar tractionThe subjects consist of 25 patients with chronic low back pain. They underwent a manual lumbar traction with Physiotherapist pulling the patients while lying prone on a couch |
| Prone traction | Experimental | Other: Prone tractionThis group consist of patients with non specific chronic low back pain that were put on prone traction. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants diagnosed with Non-Specific Low Back Pain of not less than 3 months duration who were referred by a physician.
- Participants between the ages of 40 years and older.
Key exclusion criteria (2 listed)
- Low back pain patients with specific pathology, such as systemic inflammatory diseases, pregnancy, fractures of the spine, tumors, infections.
- Participants with pathology affecting the trunk or upper and lower extremities
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 |
|---|---|---|
| Manual lumbar tractionPatient in the group were treated with manual traction | Other | manual Lumbar Traction |
| Prone tractionPatient in the group were placed on prone traction | Other | Prone traction |
Primary outcome
Visual Analogue scale
Time frame: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
It measure pain intensity: 0 which is no pain to 10 which is excruciating pain
2 secondary outcomes
Roland Morris low back pain Disability questionnaire
Time frame: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Goniometer
Time frame: Change is being assessed at the Baseline, 3rd week and 6th week of treatment
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 26 Aug 2022.
- Background: PubMed 15066687Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol. 2004 Mar;57(3):268-76. doi: 10.1016/j.jclinepi.2003.09.005.
- Background: PubMed 12384756Ozaktay AC, Cavanaugh JM, Asik I, DeLeo JA, Weinstein JN. Dorsal root sensitivity to interleukin-1 beta, interleukin-6 and tumor necrosis factor in rats. Eur Spine J. 2002 Oct;11(5):467-75. doi: 10.1007/s00586-002-0430-x. Epub 2002 Jun 4.
- Individual participant dataSharing planned: No. The data are kept with the principal investigator. Whosoever is interested can contact him for information
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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.
Adesola O Ojoawo, PhD principal investigator
Obafemi Awolowo University Ile Ife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lumbar traction and Prone traction in people with Non-specific Low Back Pain, run by Obafemi Awolowo University at 1 site in Nigeria.
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 2 inclusion and 2 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 26 Aug 2022. 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 Nigeria. 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?
Visual Analogue scale (time frame: Change is being assessed at the Baseline, 3rd week and 6th week of treatment). 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 NCT05518552, which also lists 2 linked publications.
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 26 Aug 2022.