Chronic Pelvic PainNCT05467241
A Novel Therapeutic Approach to Treat Chronic Pelvic Pain
A study testing Self-induced therapeutic tremor (SITT) combined with mindfulness in people with Chronic Pelvic Pain, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Self-induced therapeutic tremor (SITT) combined with mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
About this study
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.
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.
Read the 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
- Being tested
- Self-induced therapeutic tremor (SITT) combined with mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-induced therapeutic tremor (SITT) combined with mindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-induced therapeutic tremor (SITT) combined with mindfulness | Experimental | 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. Receives: Behavioral: Self-induced therapeutic tremor (SITT) combined with mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the pilot trial
To determine feasibility, the investigators will assess if it is possible to recruit, enroll, and have complete follow-up with participants. If the recruitment goal is met and 80% compliance with study visit attendance is achieved, the trial will be classified as feasible (yes/no classification).
Measured: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.
Secondary outcomes (7)
Change in Physical Function
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Physical Function. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a better outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Anxiety
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Anxiety. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a worse outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Depression
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Depression. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a worse outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Fatigue
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Fatigue. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a worse outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Sleep Disturbance
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Sleep Disturbance. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a worse outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Ability to Participant in Social Roles and Activities
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Ability to Participate in Social Roles and Activities. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a better outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Pain Intensity
PROMIS-29 Profile v2.0 Questionnaire will be used to assess the domain of Pain Intensity. This domain is assessed with 4 questions. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, the values of all 4 questions are summed. The lowest value is 4 and the highest value is 20. These total raw scores are converted into T-scores using the appropriate tables in the appropriate appendix in the "PROMIS ADULT PROFILE INSTRUMENTS SCORING MANUAL." The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher score represents more of this concept being measured. For this domain specifically, a higher score is a worse outcome.
The change in T-score for this domain, across time, is assessed using repeated measures ANOVA.
Measured: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start12 Aug 2021
- Primary completion29 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467241
- Sponsor's protocol ID
- 4818
- Status last verified
- Jul 2022
- First submitted
- 7 Sep 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05467241
- Acronym / sponsor ID
- 4818
- Conditions
- Chronic Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-induced therapeutic tremor (SITT) combined with mindfulness | Experimental | Behavioral: Self-induced therapeutic tremor (SITT) combined with mindfulnessThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-induced therapeutic tremor (SITT) combined with mindfulnessSITT 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. | Behavioural | Self-induced therapeutic tremor (SITT) combined with mindfulness |
Primary outcome
Feasibility of the pilot trial
Time frame: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.
To determine feasibility, the investigators will assess if it is possible to recruit, enroll, and have complete follow-up with participants. If the recruitment goal is met and 80% compliance with study visit attendance is achieved, the trial will be classified as feasible (yes/no classification).
7 secondary outcomes
Change in Physical Function
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Anxiety
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Depression
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Fatigue
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Sleep Disturbance
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Ability to Participant in Social Roles and Activities
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Change in Pain Intensity
Time frame: Pre- Program, Immediately Post-Program, and 1 Month Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-induced therapeutic tremor (SITT) combined with mindfulness in people with Chronic Pelvic Pain, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the pilot trial (time frame: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.