Clinical trial NCT05467241: A Novel Therapeutic Approach to Treat Chronic Pelvic Pain
Official title: A Pilot Study to Assess the Feasibility of a Randomized Control Trial Employing a Single-arm Intervention, at a Single Institution, to Study the Effects of Combined Self-induced Therapeutic Tremors Plus Mindfulness on Symptoms of Chronic Pelvic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combined Alternative Therapy: The novel combined alternative therapy that will be studied consists of self-induced therapeutic tremors (SITT) plus mindfulness. SITT is the intentional induction of the body's innate tremor mechanism to treat hyperarousal and muscle tension, which is characteristic of CPP. SITTs are thought to restore somatic and autonomic nervous system homeostasis, by discharging sympathetic arousal and down-regulating the autonomic nervous system. Previous work has shown that mindfulness training may improve symptoms of CPP, however there are no studies investigating the impact that the combination of mindfulness coupled with SITTs may have on the symptoms of CPP.
Primary purpose: TREATMENT

Brief summary: To collect pilot data and assess the feasibility of a trial employing a single-arm intervention to study the effects of combined self-induced therapeutic tremors plus mindfulness on symptoms of chronic pelvic pain among women diagnosed with chronic pelvic pain.

Detailed description: The estimated prevalence of chronic pelvic pain among women is 2-24%. The etiology of chronic pelvic pain is multifactorial making it very difficult to manage clinically. Evidenced-based therapies are limited and a multidisciplinary approach, including complementary and alternative medicine, to treat women with chronic pelvic pain may be the best approach. This study assess the feasibility of conducting randomized controlled trial with a single arm intervention to treat symptoms of chronic pelvis pain among women diagnosed with chronic pelvic pain. The intervention will consist of a novel combined alternative therapy intervention among women with chronic pelvic pain (self-induced therapeutic tremor plus mindfulness). This is a clinically significant project as lifestyle interventions to treat chronic pelvic pain are urgently needed, given the prevalence and the healthcare costs associated with chronic pelvic pain.

Study Objective: The primary purpose of this project is to collect pilot data and assess the feasibility of a single arm intervention trial to improve symptoms of CPP among women diagnosed with CPP.

Intervention Arm - Combined Alternative Therapy: The novel combined alternative therapy that will be studied consists of self-induced therapeutic tremors (SITT) plus mindfulness. SITT is the intentional induction of the body's innate tremor mechanism to treat hyperarousal and muscle tension, which is characteristic of CPP. SITTs are thought to restore somatic and autonomic nervous system homeostasis, by discharging sympathetic arousal and down-regulating the autonomic nervous system. Previous work has shown that mindfulness training may improve symptoms of CPP, however there are no studies investigating the impact that the combination of mindfulness coupled with SITTs may have on the symptoms of CPP.

Eligibility criteria: Inclusion Criteria:

* Women
* Age \>18
* Physical requirements: be able to complete the intervention sessions
* Not seeking other therapeutic modalities, such as acupuncture, PT, during study duration
* Free from surgery for \>3 months
* being treated clinically for chronic pelvic pain and related conditions
* CPP of 6 months or more (to be considered chronic)
* Availability to commit to the 4-week intervention (two 60-minute sessions per week at a specified time, for 4 weeks)
* Internet access and consistent access to phone/email/text communication

Exclusion Criteria:

* Pregnancy
* Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators

Primary outcomes:
measure: Feasibility of the pilot trial
timeFrame: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.
Secondary outcomes:
measure: Change in Physical Function
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Anxiety
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Depression
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Fatigue
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Sleep Disturbance
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Ability to Participant in Social Roles and Activities
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
measure: Change in Pain Intensity
timeFrame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: The University of Tennessee Graduate School of Medicine
state: Tennessee
Study officials:
References: