Clinical trial NCT04843800: Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain
Official title: Imaging Pain! Ultrasound-based Palpation and Visualization for Diagnosing Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: Ultrasound imaging
Elastography
Lumbar fascia
Acupuncture therapy
Manipulation, Chiropractic
Massage therapy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2021-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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;

Primary outcomes:
measure: % shear strain change.
timeFrame: 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:
measure: Quantitative ultrasound marker 'μ' change.
timeFrame: Change from baseline marker 'μ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'μ' at week 7 (Group 3)
measure: Quantitative ultrasound marker 'α' change.
timeFrame: Change from baseline marker 'α' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'α' at week 7 (Group 3)
measure: Quantitative ultrasound marker 'κ' change.
timeFrame: Change from baseline marker 'κ' at week 4 (Groups 1, 2 and 3). Change from week-4 marker 'κ' at week 7 (Group 3)
measure: Brief Pain Inventory short form 'pain severity' change.
timeFrame: 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)
measure: Brief Pain Inventory short form 'pain interference' change.
timeFrame: 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)
measure: Oswestry Disability Index (ODI) change.
timeFrame: Change from baseline ODI at week 4 (Groups 1, 2 and 3). Change from week-4 ODI at week 7 (Group 3)
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale change.
timeFrame: Change from baseline PROMIS Global Health at week 4 (Groups 1, 2 and 3). Change from week-4 PROMIS Global Health at week 7 (Group 3)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Nathalie J Bureau, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: