Clinical trial · Interventional
Effects of Spinal Manipulative Treatment on Inflammatory Markers in Low Back Pain Patients
Changes in Inflammatory Cytokine Levels in Response to Spinal Manipulative Treatment of Low Back Patients: A Single-blind Pilot Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is expected that mechanical low back pain (LBP) is associated with inflammatory changes localized to the affected tissues. Could such changes be detected in cells involved in the inflammatory process in an in vitro model? The investigators wish to test such a model to compare inflammatory markers in acute and chronic LBP patients and also examine the effect of spinal manipulative treatment (SMT) on changing the level of selected key inflammatory markers. The investigators hypothesize that: 1. Proinflammatory markers will be elevated while antinflammatory markers will be reduced in acute LBP patients relative to chronic back pain patients as well as in healthy study participants who have no LBP or any inflammatory conditions (controls). 2. SMT will cause a reduction in the production of proinflammatory markers while anti-inflammatory markers will increase relative to baseline levels as well as relative to controls
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Back Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spinal manipulation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Acute versus chronic low back pain
- description
- No manipulative intervention. Phlebotomy for inflammatory biomarker determinations to compare acute versus chronic at baseline.
- type
- EXPERIMENTAL
- label
- Spinal manipulation (SMT)
- description
- Inflammatory biomarker determinations after a course of 6 SMT interventions over the period of 2 weeks; a single SMT per treatment.
- interventionNames
- Other: Spinal manipulation
- type
- NO_INTERVENTION
- label
- No treatment controls
- description
- Asymptomatic subjects. Biomarker determinations at time zero and again two weeks later.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * For Asymptomatic controls: 1. Adults between the ages of 20 and 60 years 2. No pain of any etiology 3. No inflammatory conditions including musculoskeletal complaints 4. No diabetes 5. No neoplasms 6. No spinal manipulative treatments for the past 4 weeks 7. Willing to sign informed consent * For low back patients: 1. Adults between the ages of 20 and 60 years 2. Having low back pain of no longer than 4 weeks (acute) or longer than 12 weeks (chronic), with or without radiation to the lower extremity. 3. No fractures 4. NoInflammatory conditions 5. No other pain complaints 6. No diabetes 7. No spinal manipulative treatments for the past 4 weeks 8. Willing to sign informed consent Exclusion Criteria: 1. \<20 or \>60 years of age. 2. Having experienced low back pain longer than 4 wks but less than 12 wks 3. Experiencing less than 3/10 pain as judged by a VAS score determined at time of presentation to study. 4. Failure of clinician to locate a musculoskeletal indicator that will reproduce/localize the patient's pain (e.g., localized muscle tightness, soft tissue tenderness, reproduction of symptoms on digital joint challenge). 5. Currently experiencing significant pain (sprain/strain) anywhere in the body other than the low back. 6. Having been diagnosed with back pain of non-mechanical origin, including seronegative arthropathies, fibromyalgia, inflammatory joint conditions, infections, and tumors. 7. Having been diagnosed with inflammatory conditions in the past (e.g autoimmune diseases, psoriasis), or currently experiencing any inflammatory condition(s) (e.g. allergies, tooth extraction or other dental work). 8. Having been diagnosed with/experienced any infections in past 4 weeks (including common cold, oral/genital herpes, etc). 9. Having a blood clotting disorder. 10. Having received anti-inflammatory, immunosuppressive, immunostimulatory (e.g. immunization) or anticoagulant medications during the past 2 weeks. 11. Having received a spinal manipulative treatment during the past 4 weeks. 12. Unwilling to sign study consent form. 13. Unwilling/unable to adhere to study schedule. -
References
Publications (1)
- DERIVEDTeodorczyk-Injeyan JA, Triano JJ, Gringmuth R, DeGraauw C, Chow A, Injeyan HS. Effects of spinal manipulative therapy on inflammatory mediators in patients with non-specific low back pain: a non-randomized controlled clinical trial. Chiropr Man Therap. 2021 Jan 8;29(1):3. doi: 10.1186/s12998-020-00357-y. PMID 33413508