NCT04843800

Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain

Imaging Pain! Ultrasound-based Palpation and Visualization for Diagnosing Chronic Low Back Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is estimated that 23% of Quebecers suffer from chronic low back pain, and that 12% are disabled by this condition. Despite medical advances, the origin of so-called 'nonspecific low back pain' remains enigmatic. Conventional imaging methods by computed tomography and magnetic resonance may provide information on vertebral structures. However, very often, they do not diagnose lesions that genuinely correlate with the patient's symptoms. The lack of accurate diagnosis limits the therapeutic management in these patients. Therefore, patients are increasingly turning to alternative and complementary medicine therapies (e.g., acupuncture, chiropractic , osteopathy, shiatsu) to relieve their pain. These therapies target painful areas of abnormal hardening in muscles of the lower back and aim to release the tension in these tissues to control pain. However, these painful areas and their resolution after manual therapy have yet to be demonstrated by means other than manual palpation. We will conduct a randomized controlled trial in chronic low back pain patients to examine the effects of acupuncture, chiropractic therapy and therapeutic massage on lower back muscular and connective tissues' physical properties using innovative ultrasound techniques.

Detailed description

This will be a phase II, prospective, randomized controlled study, which will have received IRB approval and will be registered at Clinicaltrials.gov before it begins. Participants with chronic non specific low back pain (NSLBP) will be recruited from one site. On the day of the registration visit, the participants will meet with the research assistant to review and sign the consent form, give clinical and demographic data and respond to validated outcome questionnaires. The participants will then undergo a research dynamic ultrasound (US) of the lower back. One musculoskeletal radiologist will perform the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles, obtained during passive flexion of the lower body. Following the US exam, the participants will be randomized in three groups (allocation 1:1). One group will receive a standardized acupuncture treatment and another group will receive a standardized chiropractic treatment. One treatment session per week for 3 consecutive weeks will be provided. Following the 3 treatment sessions, at week 4, the US exam will be repeated and the questionnaires will be administered. The third group will be placed on a waiting list for 3 weeks and will be reexamined by US and respond to the questionnaires at week 4. Then, the participants will undergo a standardized therapeutic massage treatment with one treatment session per week for 3 consecutive weeks. Following the 3 treatment sessions, at week 7, the US exam will be repeated and the questionnaires will be administered.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Manual therapy	Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2021-04-14
• Last updated: 2024-08-23

Locations

1 site across 1 country: Canada