Bilateral Cervical Plexus Hydrodissection in Veterans With PTSD
Mots clés
Abstrait
La description
PTSD is a well-recognized debilitating mental health condition associated with previous trauma exposure. It is part of the DSM-5 Trauma and Stressor related disorders category. The National Vietnam Veterans Readjustment Study found that the lifetime prevalence of PTSD among veterans is 18.7%. However, most statistics regarding the prevalence of PTSD in veterans are under-represented because many transitioning veterans do not seek treatment due to concerns with the stigma of PTSD. Treatments for PTSD normally involve a multi-disciplinary approach. First-line treatments include psychotherapy and serotonergic reuptake inhibitors. Many patients fail pharmacotherapy and psychotherapy.
Unilateral stellate ganglion block performed favorably for treatment of PTSD in a recent RCT, based upon an expectation that the cervical sympathetic system is neuropathically upregulated in PTSD. However, side effects may include generalized seizures, hypotension, spinal block, and recurrent laryngeal or phrenic nerve block, and it can be performed only unilaterally due to the risk of laryngeal paralysis.
Perineural injection of peripheral nerves, plexi, or sympathetic ganglia with dextrose 5% in water (D5W), has performed well in the treatment of neuropathic upregulation in chronic pain patients. No lidocaine is required, which allows for avoidance of lidocaine toxicity risk, and because of that, bilateral procedures are feasible, if indicated. Bilateral hydrodissection of the cervical plexus (injection into the superficial cervical space) is gentle, safe, and easily performed with ultrasound guidance. Anesthetic injected in that space spreads readily into the deep cervical space, which includes the stellate ganglia. Empirical observations by the primary investigator in over 200 consecutive procedures in patients with neck or head pain who also had anxiety, brain fog, or depressive symptoms, and some of whom had formal diagnoses of PTSD, revealed consistent/spontaneous mention by the patients of near-immediate (5-10 minutes) reduction in their symptoms. A cumulative benefit has been observed, as well. The effects of BHDCP with D5W as a stand-alone treatment for PTSD has not been formally evaluated The objective of this study is to determine the immediate post-injection effects of BHDCP with D5W on anxiety, cognitive clarity, depression, or pain in U.S. veterans with PTSD. The primary hypothesis is that BHDCP with D5W will significantly reduce anxiety within 30 minutes, as measured by a 0-10 NRS score for severity of anxiety, and will outperform control injection.
Rendez-vous
| Dernière vérification: | 06/30/2020 |
| Première soumission: | 06/03/2020 |
| Inscription estimée soumise: | 06/03/2020 |
| Première publication: | 06/08/2020 |
| Dernière mise à jour soumise: | 07/02/2020 |
| Dernière mise à jour publiée: | 07/06/2020 |
| Date de début réelle de l'étude: | 07/02/2020 |
| Date d'achèvement primaire estimée: | 07/02/2021 |
| Date estimée d'achèvement de l'étude: | 03/02/2022 |
Condition ou maladie
Intervention / traitement
Procedure: Bilateral cervical plexus hydrodissestion with D5W
Procedure: Bilateral sternocleidomastoid muscle injection with D5W
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: Bilateral cervical plexus hydrodissestion with D5W Injection of 10 mL of 5% dextrose under the sternocleidomastoid muscle | Procedure: Bilateral cervical plexus hydrodissestion with D5W D5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus |
| Placebo Comparator: Bilateral sternocleidomastoid muscle injection with D5W Injection of 5 ml of 5% dextrose into the sternocleidomastoid muscle. | Procedure: Bilateral sternocleidomastoid muscle injection with D5W D5W is injected within the muscle belly of the SCM using ultrasound guidance. Pressure about the needle hub is used to simulate deeper injection |
Critère d'éligibilité
| Âges éligibles aux études | 19 Years À 19 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: - U.S. Veteran - Formal diagnosis of PTSD by a psychiatrist or psychologist - Anxiety greater than or equal to 5/10 on a 0-10 NRS scale - Stable psychotropic medication prescriptions for 3 months - 4 contact methods - Agreement to be randomized to placebo treatment for 2 months - Availability on Monday evenings - Reliable transportation - CAPS-5 Rating of greater than or equal to 40 Exclusion Criteria: - Needle phobia - Daily narcotic use - Average alcohol intake more than 2 drinks per day - Chronic pain > 5/10 - History of schizophrenia, other psychotic disorders, bipolar or personality disorder - Concussion with loss of consciousness longer than 15 minutes, confusion lasting more than 2 days, or permanent physical or behavioral impairment - Suicidal plans or thoughts in the past 2 months - Current major illness - Major surgery planned - Other current major stress economic or otherwise - Current enrollment in another clinical trial for PTSD treatment |
Résultat
Mesures des résultats primaires
1. Change from baseline to 2 months in a 0-10 Numerical Rating Scale (NRS) for Anxiety [2 months]
2. Change from baseline to 2 months in PCL-5 Score [2 months]
3. 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Anxiety from baseline to 3 months [2 months]
Mesures des résultats secondaires
1. Masking Success [5 minutes]
2. Satisfaction to 2 months as measured by a 0-10 Numerical Rating Scale (NRS) [2 months]
3. Change from baseline to 30 minutes post injection in a 0-10 Numerical Rating Scale (NRS) for Anxiety [30 minutes]
