Immediate effects of spinal manipulation, exercise, and placebo on movement in chronic low back pain
Acute Effects of Spinal Manipulative Therapy, Exercise Therapy and Open-label Placebo on Movement Performance in Individuals With Chronic Back Pain
NA · Karolinska Institutet · NCT06891625
This project will try a single session of spinal manipulation, targeted trunk exercises, and an open-label placebo to see which produces immediate improvements in movement and pain for adults with chronic non-specific low back pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Huddinge) |
| Trial ID | NCT06891625 on ClinicalTrials.gov |
What this trial studies
This is a laboratory-based, randomized cross-over experiment in which each participant receives three brief interventions (spinal manipulative therapy, exercise therapy, and an open-label placebo) in randomized order. Outcomes measured immediately after each intervention include a work-related lifting task, gait kinematics, active trunk range of motion, and pain intensity using motion-capture and clinical measures. Participants are adults with chronic non-specific back pain recruited from primary care and each intervention lasts about 5–8 minutes. The design focuses on short-term, objective changes in movement performance rather than long-term clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults (over 18) with recurring or continuous non-specific back pain for more than three months who can speak Scandinavian or English and have no red-flag conditions.
Not a fit: Patients with specific spinal pathology, inflammatory rheumatic disease, fractures, diagnosed hip osteoarthritis, fibromyalgia, neurological comorbidity, or other contraindications to spinal manipulation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the study could identify which brief interventions produce immediate improvements in movement and pain, helping clinicians choose quick strategies to restore function.
How similar studies have performed: Prior work shows short-term subjective benefits from both spinal manipulation and exercise, while open-label placebo is a newer but promising approach with some positive results in nonspecific pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons who have either experienced continuous or recurring back pain for a period longer than 3 months). Back pain is defined as problems/discomfort from the spine Th1-S1 with associated costovertebral joints and sacroiliac joints, thus including both the lumbar spine and the thoracic spine. The area of pain extends from Th1 to the inferior gluteal fold but does not include the shoulder blades * \>18 years old, * those who can speak and understand Scandinavian or English. Exclusion Criteria: * "red flags" * persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.
Where this trial is running
Huddinge
- Karolinska Institutet — Huddinge, Sweden (RECRUITING)
Study contacts
- Study coordinator: Wilhelmus JA Grooten, associated professor
- Email: Wim.Grooten@ki.se
- Phone: +46-8-52488861
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Low-back Pain, Back Disorder, chiropractic, physical therapy, open-label placebo, motion capture, acute effects, pain-intensity