Clinical trial NCT05065580: OMT as an Adjunctive Treatment in MDD
Official title: Osteopathic Manipulative Treatment as an Adjunctive Treatment in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: participants will be receiving OMT 1x/week for 8 weeks. Each appointment with be a duration of 30 minutes. Patients will be required to fill out PHQ-9 and SSS-8 questionnaires before beginning the study and following the conclusion of the study.

Detailed description: Individuals will receive weekly OMT for a duration of 8 weeks. Primary assessment will be performed on initial visit, making note of the most severe somatic restrictions, but highest priority will be given to cervical and shoulder regions (most tension is noted here in patients with MDD). Focusing on only the cranial, cervical, and shoulder regions will allow for a more standardized approach to treatment.

Osteopathic manipulative treatment (OMT) is the manipulation of tissues (muscles, joints, fascia, etc.) that is used to help restore movement and function throughout the body by a combination of stretching, gentle pressure, and resistance. The techniques we have chosen to use will focus primarily on muscle and fascia in the cranial, cervical, and shoulder regions.

Cranial techniques used include:

Suboccipital release - this helps to relieve muscle and fascial tension surrounding the head and neck, patient is supine, physician places finger pads below occipital protuberance at the base of the occiput as patient's relaxes head and lets it rest on physician's finger pads, position is held until softening of musculature is felt

Vault hold - helps to restore cranial motion, patient is supine, physician places index finger on greater wing of sphenoid, middle finger on squamous portion of temporal bone, ring finger on mastoid process of temporal bone, and pinky finger on squamous portion of occipital bone, hands remain in this position to monitor cranial motion and determine if there is a dysfunction

They will NOT be performing any high velocity low amplitude (HVLA) techniques, which requires a rapid, therapeutic force within the motion of the joint (this is the technique that is often responsible for the "cracking" or "popping")

Eligibility criteria: Inclusion Criteria:

* patients 18-65, patients with diagnosis of MDD, PHQ-9 score \> 10 at screening and baseline

Exclusion Criteria:

* history of mania, hypomania, or psychosis as defined in DSM V
* current substance abuse, including abuse within the previous 6 months
* patients with a cognitive disorder or dementia
* patients with other axis I diagnosis (anxiety disorders, dissociative disorders, etc.) that was primary in the past 6 months
* receiving other forms of manual therapy during study
* authors belief that there was significant suicidal risk
* changes in medication or psychotherapy within 6 weeks of starting study or during study period
* history of migraines
* presence of any other significant organic disease (infectious, cardiac, pulmonary, gastrointestinal, renal, etc.)
* other absolute contraindications to OMT (malignancy, infection, myelopathy, severe osteoporosis, increased ICP, intracranial bleeding, fractures, etc.)

Primary outcomes:
measure: PHQ-9 (Patient Health Questionnaire) results post treatment
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Lakeland Regional Healthcare
state: Michigan
Study officials:
References: