The METRIC Study Protocol

Official title

The METRIC Study Protocol: an Explanatory Randomized Controlled Trial Investigating the Neurophysiological Mechanisms Underlying the Therapeutic Effects of Spinal Manipulative Therapy for Chronic Primary Low Back Pain

Overview

The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when spinal manipulative therapy is applied to the whole spine where it is clinically indicated compared with lumbar spine only? • Are these effects greater after 36 treatments over 3 months compared with 12 treatments over 1 month. Participants will receive spinal manipulative therapy (all clinically indicated spine segments or back only) or a control intervention. A group of healthy volunteers will be recruited to assess secondary outcome measures over the same time period, as reference data for comparisons. Researchers will compare the two groups receiving spinal manipulative therapy to the group receiving the control intervention to see if clinical pain relief and the reduction of temporal summation of second pain (produced experimentally) is significantly greater with spinal manipulative therapy.

Interventions

• Procedure lumbar spinal manipulative therapy
  Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
• Procedure sham spinal manipulative therapy
  Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via
• Procedure full spine spinal manipulative therapy
  Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).

Primary outcome measures

• low back pain intensity [Time frame: baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.]
• temporal summation of second pain [Time frame: baseline, 4- and 12-weeks post-randomization.]

Secondary outcome measures (12)

• low back pain frequency and duration [Time frame: baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.]
• Pressure pain thresholds (PPTs) [Time frame: baseline, 4- and 12-weeks post-randomization.]
• C-fiber-related brain responses [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Oswestry Disability Index (ODI) [Time frame: baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.]
• Back performance scale (BPS) [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Five times sit-to-stand test [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Depression [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Anxiety [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Pain catastrophizing [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Kinesiophobia [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Pain vigilance [Time frame: baseline, 4- and 12-weeks post-randomization.]
• Patient's global impression of change [Time frame: After the last treatment session (12-weeks post-randomization)]

Eligibility criteria

Inclusion criteria

• Duration of current low back pain (LBP) episode ≥ 6 months;
• Average LBP intensity during the last 7 days ≥ 3/10;
• (For healthy volunteers only) To be of the same sex and age (± 1 year) as a participant with low back pain.

Exclusion criteria

• Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection, etc.;
• Presence of pain in another body location that is more severe than the pain in the lower back;
• Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes;
• Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm;
• Underwent surgery in the last 3 months;
• Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;
• History of spinal manipulative therapy in the past 12 months;
• Scoliosis ≥ 20°;
• BMI ≥ 40;
• Insufficient language skills in French to complete the questionnaires;
• Open or pending litigation for LBP or seeking/receiving disability compensation;
• Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
• Diagnosis of mental health disorders (with the exception of anxiety and depression);
• Current drug or alcohol dependence;
• Skin of type I on the Fitzpatrick scale;
• (For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
• (For healthy volunteers only) History of chronic pain;
• (For healthy volunteers only) Acute pain on the days of data collection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Université du Québec à Trois-Rivières — Trois-Rivières

Publications

• Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57-S64. doi: 10.1097/j.pain.0000000000001869. No abstract available. PMID 33090740
• Cormier S, Lavigne GL, Choiniere M, Rainville P. Expectations predict chronic pain treatment outcomes. Pain. 2016 Feb;157(2):329-338. doi: 10.1097/j.pain.0000000000000379. PMID 26447703
• Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12. PMID 33064878
• Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734. PMID 32125402
• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core PMID 15621359
• Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Chronic primary musculoskeletal pain: a new concept of nonstructural regional pain. Pain Rep. 2022 Aug 9;7(5):e1024. doi: 10.1097/PR9.0000000000001024. eCollection 2022 Sep-Oct. PMID 35975135
• Funabashi M, Gorrell LM, Pohlman KA, Bergna A, Heneghan NR. Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. PLoS One. 2022 Jul 15;17(7):e0270671. doi: 10.1371/journal.pone.0270671. eCollection 2022. PMID 35839253
• George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304. PMID 34719942

Identifiers

NCT: NCT05986370 · METRIC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗