Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain

NCT04843800 | Terminated

• 2 other identifiers: CE 21.0032021-AUDC-284121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Ultrasound imaging; Elastography; Lumbar fascia; Acupuncture therapy; Manipulation, Chiropractic; Massage therapy

Outcome Measures

Primary Outcomes (1)

• % shear strain change.

  Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.

  Change from baseline % shear strain at week 4 (Groups 1, 2 and 3). Change from week-4 % shear strain at week 7 (Group 3).

Secondary Outcomes (7)

• Quantitative ultrasound marker 'μ' change.

  Change from baseline marker 'μ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'μ' at week 7 (Group 3)

• Quantitative ultrasound marker 'α' change.

  Change from baseline marker 'α' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'α' at week 7 (Group 3)

• Quantitative ultrasound marker 'κ' change.

  Change from baseline marker 'κ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'κ' at week 7 (Group 3)

• Brief Pain Inventory short form 'pain severity' change.

  Change from baseline BPI-sf pain severity at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain severity at week 7 (Group 3)

• Brief Pain Inventory short form 'pain interference' change.

  Change from baseline BPI-sf pain interference at week 4 (Groups 1, 2 and 3). Change from week-4 BPI-sf pain interference at week 7 (Group 3)

Study Arms (3)

Acupuncture

EXPERIMENTAL

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.

Procedure: Manual therapy

Chiropractic

EXPERIMENTAL

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.

Procedure: Manual therapy

Waiting list and Therapeutic Massage

EXPERIMENTAL

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.

Procedure: Manual therapy

Interventions

Manual therapy PROCEDURE

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

Acupuncture; Chiropractic; Waiting list and Therapeutic Massage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Back pain attributable to a specific, recognizable, known pathology:
• protrusion or prolapse of 1 or more intervertebral discs with concurrent neurological symptoms;
• radicular pain (sciatica);
• infectious spondylopathy;
• low back pain caused by inflammatory, malignant, or autoimmune disease;
• congenital deformation of the spine (except for slight lordosis or scoliosis);
• compression fracture caused by osteoporosis;
• spinal stenosis;
• spondylolysis or spondylolisthesis;
• 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;

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nathalie J Bureau, MD MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Ultrasound data analysis will be blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized in three groups (allocation 1:1). Group 1 will receive a standardized acupuncture treatment and Group 2 will receive a standardized chiropractic treatment. Both groups will receive one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 4, the US exam will be repeated and the questionnaires will be administered again. Group 3 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 group 3 patients will undergo a standardized therapeutic massage treatment consisting of one treatment session per week for 3 consecutive weeks. Following the third treatment, at week 7, the US exam will be repeated and the questionnaires will be administered again.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 14, 2021
• Study Start: November 1, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)