Chronic Low Back Pain and Osteopathic Manipulation Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdward Hines Jr. VA Hospital
About this trial
The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age and older
Seeking care for LBP from a participating VA clinic
Able to follow study protocol
Willing to be randomized to Usual VA Care or Usual VA Care + OMT
Disqualifiers
Signs of serious pathology as a cause of LBP
Underlying systemic or inflammatory conditions
Neurological diseases
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Usual VA Care
Procedure/SurgeryThe usual treatment provided by PM\&R clinicians for CLBP
Osteopathic manipulative treatment
Procedure/SurgeryBetween your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Usual VA Care GroupActive comparator 1 intervention
Group B: Usual VA Care + OMT GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Low-Back Pain Specific Pain Intensity
A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.
Time frame
Baseline, 12 weeks, and 24 weeksSecondary outcomes
1
Pain, Enjoyment, General Activity Scale (PEG)
A 3-item measure to assess and to monitor different aspects of chronic pain. Originally intended to be used in a primary care setting, this instrument has been used as an outcome measure and recommended by NIH HEAL core outcome set.
Time frame
Baseline, 12 weeks, and 24 weeks2
Brief Pain Inventory (BPI)
A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain.
Time frame
Baseline, 12 weeks, and 24 weeks3
Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS Depression Short Form 4a (4 item) , PROMIS Short Form Anxiety 4a (4 item), PROMIS Physical Functioning 6b (6 item), PROMIS Sleep Disturbance 6a (6 item), PROMIS Fatigue 4a (4 item)
Time frame
Baseline, 12 weeks, and 24 weeks4
Patient Health Questionnaire (PHQ-2)
2-item questionnaire to screen for depression symptoms (frequency of depressed mood and anhedonia) during the past 2 weeks.
Time frame
Baseline, 12 weeks, and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Edward Hines Jr. VA Hospital
Lead sponsor
Michigan State University
Collaborator
Source ClinicalTrials.gov