Back to resultsEffectiveness of Chiropractic Application for Acute Low Back Pain
Primary Purpose
Low Back Pain, Mechanical
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)
Chiropractic Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Mechanical Low Back Pain, Chiropractics, Analgesic-anti-inflammatory, myorelaxant, Thiocolchicoside
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control: Drug-Only Group
Case: Drug and Chiropractic Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04110119
Brief Title
Effectiveness of Chiropractic Application for Acute Low Back Pain
Official Title
Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Mechanical Low Back Pain, Chiropractics, Analgesic-anti-inflammatory, myorelaxant, Thiocolchicoside
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control: Drug-Only Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Case: Drug and Chiropractic Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)
Intervention Description
Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages
Intervention Type
Other
Intervention Name(s)
Chiropractic Treatment
Intervention Description
High speed and low amplitude spinal manipulation techniques are applied to the case group.
Primary Outcome Measure Information:
Title
Change in pain level
Description
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.
Time Frame
Up to 5 minutes
Title
Change in pain level
Description
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.
Time Frame
Up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Medipol University
City
Beykoz
State/Province
Istanbul
ZIP/Postal Code
34810
Country
Turkey
12. IPD Sharing Statement
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Effectiveness of Chiropractic Application for Acute Low Back Pain
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