Low Back Pain, MechanicalPhase 2NCT04110119
Effectiveness of Chiropractic Application for Acute Low Back Pain
A Phase 2 study testing diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) and Chiropractic Treatment in people with Low Back Pain, Mechanical, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) and Chiropractic Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Dec 2019
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 65.
- Acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the Quebec Task Force on Spinal Disorders
Who cannot join
- Previous spine surgery
- Spinal nerve root irritation or deficits,
- Pregnant women,
- Lower-back pain due to occupational accidents
- Obesity status (body mass index> 30).
- Chronic lower-back pain longer than 6 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment
The aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines
- Conditions
- Low Back Pain, Mechanical
- Being tested
- diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM), Chiropractic Treatment
- Keywords
- Mechanical Low Back Pain, Chiropractics, Analgesic-anti-inflammatory, myorelaxant, Thiocolchicoside
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)Drug
Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages
Chiropractic TreatmentOther
High speed and low amplitude spinal manipulation techniques are applied to the case group.
| Study group | Role | What they receive |
|---|---|---|
| Control: Drug-Only Group | Active comparator | Patients with acute lower-back pain who have undergone routine conventional drug treatment at the first visit to the emergency department (49 patients). The drug treatment consists of analgesic-anti-inflammatory (diclophenac sodium 75 mg IM) and myorelaxant (thiocolchicoside 4 mg IM), administered only once. Receives: Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) |
| Case: Drug and Chiropractic Group | Experimental | Patients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (49 patients). The chiropractic treatment consists of high speed and low amplitude spinal manipulation techniques, applied only once. Receives: Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM); Other: Chiropractic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level
Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
Measured: Up to 5 minutes
Change in pain level
Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Oct 2018
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALI TIMUCIN ATAYOGLU, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110119
- Sponsor's protocol ID
- IMUEC441
- Status last verified
- Apr 2021
- First submitted
- 21 Sep 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment
- ClinicalTrials.gov ID
- NCT04110119
- Acronym / sponsor ID
- IMUEC441
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Mechanical Low Back Pain, Chiropractics, Analgesic-anti-inflammatory, myorelaxant, Thiocolchicoside
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Oct 2019 (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 aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Drug-Only Group | Active comparator | Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)Patients with acute lower-back pain who have undergone routine conventional drug treatment at the first visit to the emergency department (49 patients). The drug treatment consists of analgesic-anti-inflammatory (diclophenac sodium 75 mg IM) and myorelaxant (thiocolchicoside 4 mg IM), administered only once. |
| Case: Drug and Chiropractic Group | Experimental | Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM), Other: Chiropractic TreatmentPatients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (49 patients). The chiropractic treatment consists of high speed and low amplitude spinal manipulation techniques, applied only once. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 19 and 65.
- Acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the Quebec Task Force on Spinal Disorders
Key exclusion criteria (6 listed)
- Previous spine surgery
- Spinal nerve root irritation or deficits,
- Pregnant women,
- Lower-back pain due to occupational accidents
- Obesity status (body mass index> 30).
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 |
|---|---|---|
| diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages | Drug | Case: Drug and Chiropractic Group, Control: Drug-Only Group |
| Chiropractic TreatmentHigh speed and low amplitude spinal manipulation techniques are applied to the case group. | Other | Case: Drug and Chiropractic Group |
Primary outcome
Change in pain level
Time frame: Up to 5 minutes
Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
Change in pain level
Time frame: Up to 30 minutes
Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
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 22 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) and Chiropractic Treatment in people with Low Back Pain, Mechanical, run by Medipol University at 1 site in Turkey (Türkiye).
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 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 22 Apr 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain level (time frame: Up to 5 minutes). 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 22 Apr 2021.