Myofascial Trigger Point Pain Clinical Trial
Official title:
The Effectiveness of Trigger Point Treatment in Chronic Pelvic Pain; A Pilot Randomized Controlled Trail
Verified date | September 2022 |
Source | Munzur University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | May 1, 2019 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria:To be eligible, - participants had to be between 18-50 years of age, - had pain/discomfort in the lower abdominal and pelvic region lasting for 3 months in the last 6 months. - Patients with MTrPs in at least two of the examined muscles (rectus abdominis, piriformis, quadratus lumborum, gluteus maximus-medius, adductor magnus, hamstring) were included in order to perform statistical analysis. Exclusion Criteria: The exclusion criteria were; - anticoagulation or bleeding disorders, - neuropathy, central nervous system disorders, - advanced psychiatric disorders, - significant pelvic pathology or abnormality, severe prolapse, pregnancy, - to have undergone major surgery and pelvic surgery with general anesthesia in the last 3 months, - to have received treatment including electrotherapy and manual therapy for the pelvic region in the last 6 months. |
Country | Name | City | State |
---|---|---|---|
Turkey | Munzur University | Tunceli |
Lead Sponsor | Collaborator |
---|---|
Munzur University | Istanbul University-Cerrahpasa |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) . | 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 | |
Primary | 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 . | 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 | |
Secondary | 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. | 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 | |
Secondary | 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). | 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 | |
Secondary | 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). | 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 | |
Secondary | 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. | 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 | |
Secondary | 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) | 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 | |
Secondary | 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 . | 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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