Myofascial Pelvic PainNCT04746352
Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
A study testing BES-SMFR and BES in people with Myofascial Pelvic Pain, run by Zhongda Hospital at 1 site in China.
Trial summary
Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Myofascial Pelvic Pain
- What is being tested?
- BES-SMFR and BES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2019
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years;
- presence of persistent chronic pelvic pain ≥ 4 points on a 10 points numeric rating scale for at least 3 months;
- at least one active MTrP in one of muscle group including obturator internus, levator ani, piriformis, coccygeus on pelvic examination.
Who cannot join
- diseases of the urinary, genital, colorectal systems;
- prolapse of the pelvic organ;
- a history of pelvic rehabilitation within the 3 months prior to study;
- psychiatric disorders;
- pregnancy;
- breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of Myofascial Pelvic Pain
Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES alone in patients with MFPP.
Read the detailed description
68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree in activation of MTrPs, surface electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).
- Conditions
- Myofascial Pelvic Pain
- Being tested
- BES-SMFR, BES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BES-SMFRProcedure or surgery
For the BES intervention, it was performed using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. BES was performed once every 2 days for 4 weeks.
BESProcedure or surgery
First, a standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. Second, patients were required to participate in intensive training regarding myofascial release techniques. Following the training, SMFR was regularly performed by at home for 5 minutes daily for 4 weeks. SMFR was confirmed with patients at all their follow up visits.
| Study group | Role | What they receive |
|---|---|---|
| BES-SMFR group | Experimental | Using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. Three standardized programs were used in our study: (1) Tens electricity (first program): 5 min of 50-280 Hz frequency and a pulse duration of 50 µs. (b) Endorphin electricity (second program): 5 min of 1-10 Hz frequency and a pulse duration of 200 µs. (c) Spasmolysis electricity (third program): 5 min of 1-2 Hz frequency and a pulse duration of 300 µs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. Receives: Procedure: BES-SMFR |
| BES group | Active comparator | 1. A standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use.
2. Patients were required to participate in intensive training regarding myofascial release techniques. (I) Pressing: press directly on a specific MTrP with gentle, slow pressures (2kg/cm2) using a flat palpation, the pressure was sustained until the participant perceived the pain decreased and taut band released, and then gradually increased to previous level of MTrPs tension and maintained until a reduction of pain again. The process was usually 3 to 5 repetitions for 90 sec. (II) Stretching: stretch in parallel to the direction of the myofascial to facilitate elongation of a contracted muscle. (III) Strumming: stroking and strumming the affected muscles region with the fingertips to aid in MTrPs tension release, the initial pressure was small and increased gradually until the patients adapted. Receives: Procedure: BES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of pain intensity
Pain intensity was calculated by using the visual numeric rating scale (NRS), which is a 11-point rating scale ranging from "0" (no pain) to "10" (worst pain imaginable) . For each patient, the NRS referred to pain elicited while palpating bilaterally each PFM groups and was averaged pain across all the muscles. Upon palpation, the patient was asked to place in a resting, semi-recumbent position with legs supported by pillow to prevent excessive tension in the PFMs.
Measured: Up to 12 weeks
Secondary outcomes (3)
The degree in activation of MTrPs
MTrPs were considered as active when the following criteria was met: (1) Presence of a palpable taut band in the muscle; (2) Presence of a hypersensitive spot in the taut band; (3) Local twitch response elicited by snapping palpation; (4) Reproduction of the typical referred pain pattern in response to the compression of tender spots; and (5) Spontaneous presence of the typical referred pain pattern. Active MTrPs localized mainly in the bilateral obturator internus, levator ani, piriformis and coccygeus were assessed respectively by pelvic floor manual palpation. Using the inclusion criterion of having active MTrPs at least one in the bilateral muscles as a cutoff point.
Measured: Up to 12 weeks
Surface electromyography (sEMG) levels of the PFMs
The PFMs sEMG assessment was performed based on Glazer protocol by using the device of Vishee neuro-muscle stimulator (MyoTrac Infiniti, model SA9800, Thought Technology Ltd., Montreal, Canada). The sEMG amplitude mean value based on Glazer protocols for selected tasks were follows: 60-s pretest resting baseline, assessing the resting amplitude of PFM before the test sequence; 5 rapid contractions (quick flicks), assessing fast muscles function; 60-s endurance contraction, assessing slow muscles function; 60-s posttest resting baseline, assessing the resting amplitude of PFM after the test sequence.
Measured: Up to 12 weeks
The score of Patient Global Impression of Improvement (PGI-I)
PGI-I is a patient self-reporting evaluation that assesses overall perception of response to treatment according to a 7-point scale, including very much worse, much worse, a little worse, no change, a little better, much better or very much better, with lower scores indicating more favorable outcomes. Better response to treatment was considered when a PGI-I score < 3 (very much better or much better).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shen, Zhongda Hospital
- Investigators
- Yang Shen, MD,PhD, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746352
- Sponsor's protocol ID
- Zhongda Hospital
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 9 Feb 2021
- 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of Myofascial Pelvic Pain
- ClinicalTrials.gov ID
- NCT04746352
- Acronym / sponsor ID
- Zhongda Hospital
- Conditions
- Myofascial Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Feb 2021 (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.
Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES alone in patients with MFPP.
Detailed description
68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree in activation of MTrPs, surface electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BES-SMFR group | Experimental | Procedure: BES-SMFRUsing the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. Three standardized programs were used in our study: (1) Tens electricity (first program): 5 min of 50-280 Hz frequency and a pulse duration of 50 µs. (b) Endorphin electricity (second program): 5 min of 1-10 Hz frequency and a pulse duration of 200 µs. (c) Spasmolysis electricity (third program): 5 min of 1-2 Hz frequency and a pulse duration of 300 µs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. |
| BES group | Active comparator | Procedure: BES1. A standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. 2. Patients were required to participate in intensive training regarding myofascial release techniques. (I) Pressing: press directly on a specific MTrP with gentle, slow pressures (2kg/cm2) using a flat palpation, the pressure was sustained until the participant perceived the pain decreased and taut band released, and then gradually increased to previous level of MTrPs tension and maintained until a reduction of pain again. The process was usually 3 to 5 repetitions for 90 sec. (II) Stretching: stretch in parallel to the direction of the myofascial to facilitate elongation of a contracted muscle. (III) Strumming: stroking and strumming the affected muscles region with the fingertips to aid in MTrPs tension release, the initial pressure was small and increased gradually until the patients adapted. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 70 years;
- presence of persistent chronic pelvic pain ≥ 4 points on a 10 points numeric rating scale for at least 3 months;
- at least one active MTrP in one of muscle group including obturator internus, levator ani, piriformis, coccygeus on pelvic examination.
Key exclusion criteria (6 listed)
- diseases of the urinary, genital, colorectal systems;
- prolapse of the pelvic organ;
- a history of pelvic rehabilitation within the 3 months prior to study;
- psychiatric disorders;
- pregnancy;
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 |
|---|---|---|
| BES-SMFRFor the BES intervention, it was performed using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. BES was performed once every 2 days for 4 weeks. | Procedure or surgery | BES-SMFR group |
| BESFirst, a standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. Second, patients were required to participate in intensive training regarding myofascial release techniques. Following the training, SMFR was regularly performed by at home for 5 minutes daily for 4 weeks. SMFR was confirmed with patients at all their follow up visits. | Procedure or surgery | BES group |
Primary outcome
The change of pain intensity
Time frame: Up to 12 weeks
Pain intensity was calculated by using the visual numeric rating scale (NRS), which is a 11-point rating scale ranging from "0" (no pain) to "10" (worst pain imaginable) . For each patient, the NRS referred to pain elicited while palpating bilaterally each PFM groups and was averaged pain across all the muscles. Upon palpation, the patient was asked to place in a resting, semi-recumbent position with legs supported by pillow to prevent excessive tension in the PFMs.
3 secondary outcomes
The degree in activation of MTrPs
Time frame: Up to 12 weeks
Surface electromyography (sEMG) levels of the PFMs
Time frame: Up to 12 weeks
The score of Patient Global Impression of Improvement (PGI-I)
Time frame: Up to 12 weeks
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 9 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Myofascial Pelvic Pain
Not yet recruiting
Comparison of Shockwave Therapy and Apuncture for Chronic Pelvic Pain
Chronic Pain Syndromes
Not yet recruiting
Effects of MET and MFR on Piriformis Syndrome
Piriformis Syndrome
Recruiting
Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea
Dysmenorrhea Primary
Not yet recruiting
Comparing Two Soft Tissues Technique on Piriformis Syndrome Patients
Piriformis Syndrome, Musculoskeletal Abnormalities
Recruiting
Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Polycystic Ovarian Syndrome.
Polycystic Ovarian Syndrome
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.
Yang Shen, MD,PhD study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BES-SMFR and BES in people with Myofascial Pelvic Pain, run by Zhongda Hospital at 1 site in China.
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 3 inclusion and 6 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 9 Feb 2021. 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 China. 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?
The change of pain intensity (time frame: Up to 12 weeks). 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 9 Feb 2021.