Trigger Point Treatment in Chronic Pelvic Pain

NCT05546203 | Completed

• 1 other identifier: Kubra_2018
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain Syndrome; Myofascial Trigger Point Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Range of Motion (ROM)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

Ischemic compression (IC) group

EXPERIMENTAL

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 (LLLT) group

EXPERIMENTAL

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

Interventions

Ischemic compression 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"

Ischemic compression (IC) group

Low-level laser therapy 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.

Low-level laser therapy (LLLT) group

Standardized exercise program 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.

Ischemic compression (IC) group; Low-level laser therapy (LLLT) group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Munzur University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Munzur University

Tunceli, Turkey (Türkiye)

Location

Related Links

• Laser therapy and needling in myofascial trigger point deactivation
• Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Acupressure; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy

Study Officials

• Kübra Sağır Ataş, MSC

  Munzur University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized parallel designed two arm clinical study

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: May 1, 2019
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)