A Novel Therapeutic Approach to Treat Chronic Pelvic Pain

NCT ID: NCT05467241

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2022-05-30

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.

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-induced therapeutic tremor (SITT) combined with mindfulness

This arm will consist of self-induced therapeutic tremor (SITT) training combined with mindfulness training that is performed during a 60 minute session, 2 times per week, for 4 weeks.

Self-induced therapeutic tremor (SITT) combined with mindfulness: SITT is a way to reduce stress by turning on a natural shaking response. This can calm the participant's body. It involves doing simple exercises. During SITT muscles will gently shake, and release built up stress. This shaking of muscles lets the participant's body physically let go of tension and stress. Mindfulness is the ability to be fully present in a moment so that the participant can focus on what the participant is sensing and feeling in the moment. It involves the acceptance of thoughts and feelings without judging them. Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind, help reduce stress, and not be overwhelmed.

Group Type: EXPERIMENTAL

Self-induced therapeutic tremor (SITT) combined with mindfulness

Intervention Type: BEHAVIORAL

SITT is a way to reduce stress by turning on a natural shaking response. This can calm the participant's body. It involves doing simple exercises. The muscles will gently shake, and release built up stress. This shaking of the muscles lets the participant's body physically let go of tension and stress.

Mindfulness is the ability to be fully present in a moment. This allows focus on what the participant is sensing and feeling in the moment. It involves the acceptance of thoughts and feelings without judging them.

Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind, help reduce stress, and not be overwhelmed by what's going on around the participant.

Interventions

Self-induced therapeutic tremor (SITT) combined with mindfulness

SITT is a way to reduce stress by turning on a natural shaking response. This can calm the participant's body. It involves doing simple exercises. The muscles will gently shake, and release built up stress. This shaking of the muscles lets the participant's body physically let go of tension and stress.

Mindfulness is the ability to be fully present in a moment. This allows focus on what the participant is sensing and feeling in the moment. It involves the acceptance of thoughts and feelings without judging them.

Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind, help reduce stress, and not be overwhelmed by what's going on around the participant.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

4818

Identifier Type: -

Identifier Source: org_study_id