An interventional study of Ischemic compression and Low-level laser therapy in Chronic Pelvic Pain Syndrome and Myofascial Trigger Point Pain, sponsored by Munzur University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by Munzur University · Not applicable, Interventional, and Treatment
Objective: To investigate the effectiveness of ischemic compression and low-level laser therapy methods combined with exercise on the myofascial trigger points in women with Chronic Pelvic Pain and to determine which method is more effective.
Methods: It was a parallel designed, single-blind pilot randomized clinical trial. Patients were enrolled in the Department of Obstetrics and Gynecology (at Istanbul University-Cerrahpasa). The patients were diagnosed by a gynecologist (F.G.U and C. Y.), referred to the clinical laboratory of physiotherapy and rehabilitation to participate (by physiotherapists K.S. and E.K.M.) in the trial from September 2017 to June 2019. Twenty-eight women patients with Chronic Pelvic Pain were included into the trial. Patients were randomized into two groups. Group 1 received ischemic compression and Group 2 received low-level laser therapy twice a week for 6 weeks. Both groups received the same standard exercise program. Pain, range of motion, pelvic floor symptom severity, quality of life, satisfaction, anxiety, and depression were assessed after 6 weeks and 1-year follow up.
Chronic pelvic pain (CPP) is chronic or persistent pain perceived in structures related to the pelvic region. CPP prevalence range between 5.7 % and 26.6 % in women. CPP is associated with symptoms suggestive of the lower urinary tract, sexual, bowel, pelvic floor, or gynecological dysfunction. It is often associated with negative emotional consequences and impaired quality of life (QoL) Analgesics, hormone therapy, physiotherapy, psychological treatment, and surgical methods are widely used in the treatment of CPP. Medications provide pain and visceral management, surgery provides correction of structure, but physiotherapy approachs provides functional restoration. Musculoskeletal pelvic pain is commonly originated myofascial, musculoskeletal, neuromuscular structures. CPP patients have myofascial trigger points (MTrPs) located in the lower back, abdominal wall, and pelvic girdle, which may be the primary source of pain. These MTrPs are usually located in levator ani, obturator internus, piriformis, gluteal muscles, quadratus lumborum and abdominal wall muscles. The MTrPs are hyperirritable spots within a taut band, activated by repeated or chronic muscular overload.
Ischemic compression (IC), in the other words trigger point compression, is an effective method in the treatment of MTrPs in many musculoskeletal problems. IC changes the circulatory perfusion of skin and is especially valuable in muscles that are not suitable for stretch. It is less common to use pelvic floor rehabilitation, urological CPP, interstitial cystitis and painful bladder syndrome and CPP yet. Low-level laser therapy (LLLT) reduces pain in MTrPs lead to musculoskeletal system disorders. LLLT increases oxygen supply to hypoxic cells in MTrPs areas by regulating microcirculation as well as it has analgesic, biostimulation, and wound healing effects . In the literature, it is seen that IC and LLLT are effective on MTrPs, and IC is used in pelvic pain in a few studies. But the use of LLLT in pelvic pain has not been found. It is a known fact that exercise is the basis for these MTrPs treatments. In light of this knowledge, investigetors hypothesized that both IC and LLLT combined with exercise would be an effective methods in the management of CPP.
1,142 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Munzur University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Inclusion Criteria:To be eligible,
Exclusion Criteria: The exclusion criteria were;
Ischemic compression group received ischemic compression and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes.
Other: Ischemic compression · Behavioral: Standardized exercise program
Low-level laser therapy group received Low-level laser therapy and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes.
Device: Low-level laser therapy · Behavioral: Standardized exercise program
IC was applied over the detected MTrPs and the participant was asked to describe the pressure and pain she felt . It was started with moderate tolerable pressure (7/10) and then severity was increased. The color of the thumb pulp was observed to control the pressure. The pressure was continued for 90 sec. The patient's pain sensation continued to be questioned and the pressure was controlled to a level at "comfortable pain"
LLLT was applied for 90 sec at each MTrPs with a frequency of 2000 Hz (3 J) using a GaAs diode laser instrument (Roland Serie Elettronica Pagani, wavelength 904 nm, the frequency range of 5-7000 Hz and maximum peak power of 27, 50 or 2764 W) . The laser probe was held perpendicular to the MTrPs in skin contact without pressure.
The standardized exercise program included stretching and pilates exercises for core stabilization. All exercises were supervised by the same physiotherapist whom certificated by The Australian Physiotherapy and Pilates Institute (APPI). Pilates exercises were selected from APPI's mat-work exercises and performed in accordance with APPI principles. In addition, patients performed stretching exercises for 5 days a week and pilates exercises for 3 days a week at home.
Visual analog scale (VAS)
Pain intensity was assessed using the VAS, in which the patients were asked to indicate their perceived pain during rest, activity and at night (0-10 numeric pain rating scale, with 0 as no pain and 10 as worst imaginable pain) .
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Pressure Pain Threshold (PPT)
Handheld pressure algometer (Commander Algometer, J Tech Medical Industries, Midvale, Utah; maximum output=111.6N/cm2) was used to measure PPT on the MTrPs determined by clinical examination. Investigetors asked the subjects to say "stop" as soon as a discernible sensation of pain was felt. When the subject lying on loose position, a 1-cm2 algometer probe was placed perpendicularly on the MTrPs, and the pressure was increased gradually (1 lb/s). First painful threshold was recorded, mean value of two measurements, with 3 minutes interval, was used for analysis .
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Range of Motion (ROM)
Lumbar spine active ROM from full extension to full flexion, and hip active ROM on flexion, extension and mediolateral rotation was measured using a digital goniometer (Baseline Evaluation Instrument®, Fabrication Enterprises, Inc.). Average of 3 repetitions was recorded for analysis.
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Pelvic Floor Bother Questionnaire (PFBQ)
The Pelvic Floor Bother Questionnaire (PFBQ) was used to identify the presence and degree of bother related to common pelvic floor problems. It had excellent test-retest reliability (0.998, p\<0.0001).
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Urogenital Distress Inventory (UDI-6)
Urogenital Distress Inventory (UDI-6) was used to assess urinary symptoms related QoL. It consists of 6 questions covering three domains: stress urinary incontinence, detrusor overactivity, bladder outlet obstruction. It had high internal consistency (Cronbach's alpha: 0.74) and test-retest reliability (Spearman's rho:0.99, p\<0.001).
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Short Form Health Survey-36 (SF-36)
Short Form Health Survey-36 (SF-36) was used to assess the general QoL. It consists of 36 items, 8 sub-scales; physical and social functioning, role limitations due to physical health and emotional problems, emotional well-being, pain, energy-fatigue, general health status. It has recently been shown to be highly reliable (Cronbach alpha value of the subscales varied in the range 0.792-0.992) in chronic pain.
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) was used to identify the anxiety disorders and depression among patients. It has anxiety and depression subscale, both containing seven items. It had high internal consistency (Cronbach's alpha coefficient: 0.8525 for anxiety subscale and 0.7784 for depression subscale)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Patient Global Impression of Improvement (PGII)
Patient Global Impression of Improvement (PGII) used to assess patient satisfaction. It consists of 7-point question (1=very much better, 7=very much worse) asking the patient's level of recovery after treatment. PGII have a significant correlation with incontinence episode frequency, stress pad test, and incontinence-related quality of life .
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
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Munzur University