Trigger Point Treatment in Chronic Pelvic Pain

NCT ID: NCT05546203

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Pelvic Pain Syndrome; Myofascial Trigger Point Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ischemic compression (IC) group

Ischemic compression group received ischemic compression and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes.

Group Type: EXPERIMENTAL

Ischemic compression

Intervention Type: OTHER

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"

Standardized exercise program

Intervention Type: BEHAVIORAL

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.

Low-level laser therapy (LLLT) group

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.

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: DEVICE

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.

Standardized exercise program

Intervention Type: BEHAVIORAL

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.

Interventions

Ischemic compression

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"

Intervention Type: OTHER

Low-level laser therapy

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.

Intervention Type: DEVICE

Standardized exercise program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Munzur University

OTHER

Sponsor Role: lead

Responsible Party

Kubra Sagır

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kübra Sağır Ataş, MSC

Role: PRINCIPAL_INVESTIGATOR

Munzur University

Locations

Munzur University

Tunceli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

https://www.jstage.jst.go.jp/article/josnusd/55/2/55_175/_article/-char/ja/

Laser therapy and needling in myofascial trigger point deactivation

http://dx.doi.org/10.1186/s12871-015-0155-0

Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain.

Other Identifiers

Kubra_2018

Identifier Type: -

Identifier Source: org_study_id