Lumbar OsteoarthritisNCT05693415
Primary Osteoarthritis Lumbar Spine: Establishing Its Cause, Pathogenesis and Treatment.
An observational study of Lumbar Osteoarthritis, run by Knee Pain Clinic at 6 sites in India.
Trial summary
The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Lumbar Osteoarthritis
- How many people
- 154 participants
- Where
- 6 sitesIndia
- Study dates
- 1 Jul 2021to 15 Oct 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group includes people across locations in and Gwalior city. Trial was based on "Pragmatic Cluster Randomized Controlled Trial", also known as Cluster Randomized Trial (CRT) or Group Randomized Trial. In this variety pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. The subjects, who consulted me, were of two types. The type I wanted to avoid surgery, had tried other nonsurgical options and did not want those anymore. These patients were included in trial group and took my designed treatment (Contracture Correction Therapy = CCT). The other type of patients who did not consent for the new treatment were included in the control group.
Who may be able to join
- Age =>30 and <=90 years
- Back/leg pain or both combined, which appears without any apparent cause, exacerbated by exertion and subsides by rest.
- Presence of limited morning stiffness
- No history of infection, inflammation or trauma to rule out secondary OA
- Disability in sitting, climbing stairs or walking
Who cannot join
- Neckache
- Frozen shoulder
- Central obesity
- Acute Lumbago
- X-ray spine with no OA signs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Arogya Sadan Nursing Home
Bhind, Madhya Pradesh, 477001
Sai Baba Dharmarth Chikitsalaya
Gwalior, Madhya Pradesh, 474003
Knee Pain Clinic
Gwalior, Madhya Pradesh, 474012
Lok Hitkari Trust Health Camp
Gwalior, Madhya Pradesh, 474012
Parashar Poly Clinic
Gwalior, Madhya Pradesh, 474012
Dr. Shukla Surgery Center
Morena, Madhya Pradesh, 476001
About this study
Official title: Primary Osteoarthritis Lumbar Spine Presenting as Chronic Low Back Pain or Sciatica or Both (Prolapsed Lumbar Disc Syndrome): Establishing Its Cause, Pathogenesis and Treatment.
The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 154 patients (100 in the trial group, 50 in the control group) for a duration of six months.
Read the detailed description
The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact cause and treatment are not known. It was aimed to find out to latter through a hypothesis by designing a treatment and testing it with a clinical trial.
This established that the deficient full extension of the spinal joints (intervertebral joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by intermittent and sustained extension of the lumbar spin through three designed body postures.
- Conditions
- Lumbar Osteoarthritis
- Keywords
- Osteoarthritis, Lumbar Spine, Intervertebral Joint, Capsule Contracture, Discectomy, Ideopathic
- Medical subject headings
- Osteoarthritis, Spine, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No treatment | |
| Trial Group | Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
Measured: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks
Secondary outcomes (2)
Oswestry Disability Index
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Measured: Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks
EuroQol Visual Analogue Scale score
The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Measured: Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar OsteoarthritisStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knee Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR R C Agrawal, Knee Pain Clinic
- Investigators
- R C Agrawal, MS Surgery, Principal investigator, Knee Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693415
- Sponsor's protocol ID
- 1002
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2022
- Last updated
- 23 Jan 2023
- 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Osteoarthritis Lumbar Spine Presenting as Chronic Low Back Pain or Sciatica or Both (Prolapsed Lumbar Disc Syndrome): Establishing Its Cause, Pathogenesis and Treatment.
- ClinicalTrials.gov ID
- NCT05693415
- Acronym / sponsor ID
- 1002
- Conditions
- Lumbar Osteoarthritis
- Keywords
- Osteoarthritis, Lumbar Spine, Intervertebral Joint, Capsule Contracture, Discectomy, Ideopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Knee Pain ClinicUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 23 Jan 2023 (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 was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 154 patients (100 in the trial group, 50 in the control group) for a duration of six months.
Detailed description
The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact cause and treatment are not known. It was aimed to find out to latter through a hypothesis by designing a treatment and testing it with a clinical trial.
This established that the deficient full extension of the spinal joints (intervertebral joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by intermittent and sustained extension of the lumbar spin through three designed body postures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –No treatment |
| Trial Group | – | –Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group includes people across locations in and Gwalior city. Trial was based on "Pragmatic Cluster Randomized Controlled Trial", also known as Cluster Randomized Trial (CRT) or Group Randomized Trial. In this variety pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. The subjects, who consulted me, were of two types. The type I wanted to avoid surgery, had tried other nonsurgical options and did not want those anymore. These patients were included in trial group and took my designed treatment (Contracture Correction Therapy = CCT). The other type of patients who did not consent for the new treatment were included in the control group.
Key inclusion criteria (5 listed)
- Age =>30 and <=90 years
- Back/leg pain or both combined, which appears without any apparent cause, exacerbated by exertion and subsides by rest.
- Presence of limited morning stiffness
- No history of infection, inflammation or trauma to rule out secondary OA
- Disability in sitting, climbing stairs or walking
Key exclusion criteria (5 listed)
- Neckache
- Frozen shoulder
- Central obesity
- Acute Lumbago
- X-ray spine with no OA signs
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
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
2 secondary outcomes
Oswestry Disability Index
Time frame: Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks
EuroQol Visual Analogue Scale score
Time frame: Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks
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 23 Jan 2023.
- 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.
R C Agrawal, MS Surgery principal investigator
Knee Pain Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Osteoarthritis, run by Knee Pain Clinic at 6 sites 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 5 inclusion and 5 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks). 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 23 Jan 2023.