Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain

NCT ID: NCT04843800

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-07-24

Brief 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

Study Design

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

Study Groups

Acupuncture

The acupuncture treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. The acupuncture treatment protocol will be semi standardized according to usual practice. All patients will be treated with a selection of local and distant points, comprising 10 minutes of insertion time, 30 minutes of needle retention and manipulation to achieve de qi (an irradiating feeling) if possible.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: PROCEDURE

Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.

Chiropractic

The chiropractic treatments will consist of one 20-minute session weekly, for 3 consecutive weeks. The Diversified technique is one of the most commonly practiced techniques by chiropractors. In the treatment of low back pain, this technique involves the application of a quick (high-velocity), short (low-amplitude) thrust (adjustment) to the lumbo-pelvic area.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: PROCEDURE

Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.

Waiting list and Therapeutic Massage

The therapeutic massage treatments will consist of one 45-minute session weekly, for 3 consecutive weeks. A technique called Fascial Release will be used. Tension related to back pain is believed to be present not only in the back but also in various parts of the body such as the legs, through the connection of fascia, the membrane that surrounds the muscles. The purpose of this treatment is to reduce the tension connected to the lower back.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: PROCEDURE

Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.

Interventions

Manual therapy

Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ongoing low back and/or referred pain (non-specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 3 months;
• Pain has resulted in a problem on at least 50% of the days in the past 6 months;
• Only use of oral non-steroidal anti-inflammatory drugs for pain treatment in the 4 weeks before treatment;
• Willingness to commit to treatment sessions (acupuncture, chiropractic therapy or therapeutic massage) and to follow-up visits.

Exclusion Criteria

• Back pain attributable to a specific, recognizable, known pathology:

1. protrusion or prolapse of 1 or more intervertebral discs with concurrent neurological symptoms;

2. radicular pain (sciatica);

3. infectious spondylopathy;

4. low back pain caused by inflammatory, malignant, or autoimmune disease;

5. congenital deformation of the spine (except for slight lordosis or scoliosis);

6. compression fracture caused by osteoporosis;

7. spinal stenosis;

8. spondylolysis or spondylolisthesis;

9. Pregnancy;

• History of spinal surgery;
• History of pelvis or hip fractures;
• Acupuncture, spinal manipulation or therapeutic massage for back pain within the past year;
• Severe clotting disorders or anticoagulant therapy;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie J Bureau, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2021-AUDC-284121

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CE 21.003

Identifier Type: -

Identifier Source: org_study_id