Back to resultsEffectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
Primary Purpose
Myofascial Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BES-SMFR
BES
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pelvic Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongda Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BES-SMFR group
BES group
Arm Description
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.
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. 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04746352
Brief Title
Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
Official Title
Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of Myofascial Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BES-SMFR group
Arm Type
Experimental
Arm Description
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.
Arm Title
BES group
Arm Type
Active Comparator
Arm Description
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.
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.
Intervention Type
Procedure
Intervention Name(s)
BES-SMFR
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
BES
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of pain intensity
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
The degree in activation of MTrPs
Description
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.
Time Frame
Up to 12 weeks
Title
Surface electromyography (sEMG) levels of the PFMs
Description
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.
Time Frame
Up to 12 weeks
Title
The score of Patient Global Impression of Improvement (PGI-I)
Description
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).
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Shen, MD,PhD
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
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