Low Back PainNCT02128438
Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study
An observational study of Low Back Pain, run by Swami Vivekanand National Institute of Rehabilitation Training and Research at 1 site in India.
Trial summary
In general , the diagnosis of back pain can be broken into three major categories: Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders , neuropathic joints , visceral diseases ). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Low Back Pain
- How many people
- 940 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2007to Sep 2012
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Persons with low back pain who had attended our hospital and sub centres with a complaint of low back pain
Who may be able to join
- mechanical low back pain with or without radiation to lower limb.
Who cannot join
- any recent trauma or fractures to cervico-thoracic junction, osteoporosis, inflammatory arthritis, tuberculosis, bone disease, congenital deformity
- vascular disorders
- rapidly progressing neurological deficits
- sudden onset of neurological deficits and all red flags to manual therapy.
Trial locations and contacts
1 site in 1 country.
About this study
In general , the diagnosis of back pain can be broken into three major categories: Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders , neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red herrings that must be considered most seriously.
The investigators have observed in their practice that lateral pressure on 5th lumbar vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over cervicothoracic spines reproduce original low back and leg pain. So the question arises whether Cervico-thoracic dysfunction is associated with low back pain with or without radiation to lower extremities?
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cervico-thoracic dysfunction in patients with low back pain
incidence of cervico-thoracic dysfunction in patients with low back pain with or without radiation down the lower extremity, which is characterized by reproduction of the original symptom by central PA pressure of cervicothoracic spines and digital pressure by algometer over levator scapulae
Measured: The outcome measure, viz. the incidence of cervico-thoracic dysfunction was ascertained immediately at the time of initial physical assessment. No follow-up was required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2007
- Primary completionSep 2012
- Study completionSep 2012
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.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swami Vivekanand National Institute of Rehabilitation Training and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P.P.Mohanty, Swami Vivekanand National Institute of Rehabilitation Training and Research
- Investigators
- Patitapaban Mohanty, PhD, Principal investigator, Swami Vivekanand National Institute of Rehabilitation Training and ResearchBasant K Behera, M.S (Ortho), Study chair, SCB medical college and hospital, Cuttack
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128438
- Sponsor's protocol ID
- mohanty0202
- Status last verified
- Apr 2014
- First submitted
- 25 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study
- ClinicalTrials.gov ID
- NCT02128438
- Acronym / sponsor ID
- mohanty0202
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- Swami Vivekanand National Institute of Rehabilitation Training and ResearchUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 May 2014 (estimated)
- 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.
In general , the diagnosis of back pain can be broken into three major categories: Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders , neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red herrings that must be considered most seriously.
The investigators have observed in their practice that lateral pressure on 5th lumbar vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over cervicothoracic spines reproduce original low back and leg pain. So the question arises whether Cervico-thoracic dysfunction is associated with low back pain with or without radiation to lower extremities?
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Persons with low back pain who had attended our hospital and sub centres with a complaint of low back pain
Key inclusion criteria (1 listed)
- mechanical low back pain with or without radiation to lower limb.
Key exclusion criteria (4 listed)
- any recent trauma or fractures to cervico-thoracic junction, osteoporosis, inflammatory arthritis, tuberculosis, bone disease, congenital deformity
- vascular disorders
- rapidly progressing neurological deficits
- sudden onset of neurological deficits and all red flags to manual therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of cervico-thoracic dysfunction in patients with low back pain
Time frame: The outcome measure, viz. the incidence of cervico-thoracic dysfunction was ascertained immediately at the time of initial physical assessment. No follow-up was required.
incidence of cervico-thoracic dysfunction in patients with low back pain with or without radiation down the lower extremity, which is characterized by reproduction of the original symptom by central PA pressure of cervicothoracic spines and digital pressure by algometer over levator scapulae
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 1 May 2014.
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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.
Patitapaban Mohanty, PhD principal investigator
Swami Vivekanand National Institute of Rehabilitation Training and Research
Basant K Behera, M.S (Ortho) study chair
SCB medical college and hospital, Cuttack
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Swami Vivekanand National Institute of Rehabilitation Training and Research at 1 site in India.
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 1 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 1 May 2014. 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 India. 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?
incidence of cervico-thoracic dysfunction in patients with low back pain (time frame: The outcome measure, viz. the incidence of cervico-thoracic dysfunction was ascertained immediately at the time of initial physical assessment. No follow-up was required.). 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 1 May 2014.