Chronic Low-back PainMETRICNCT05986370

The METRIC Study Protocol

A study testing lumbar spinal manipulative therapy and full spine spinal manipulative therapy in people with Chronic Low-back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Low-back Pain
What is being tested?: lumbar spinal manipulative therapy and full spine spinal manipulative therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 1 siteCanada
Study dates: 25 Oct 2023to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Benjamin Provencher contact

1-819-376-5011 ext. 4996

metric@uqtr.ca

Mathieu Piché contact

1-819-376-5011 ext. 3998

metric@uqtr.ca

Canada1 site, 1 recruiting

Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
Benjamin Provencher, D.C., M.Sc., 18196906403, metric@uqtr.ca
Recruiting

Other trials in Canada

About this study

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

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.

Conditions: Chronic Low-back Pain
Being tested: lumbar spinal manipulative therapy, sham spinal manipulative therapy, full spine spinal manipulative therapy
Keywords: chronic primary low back pain, spinal manipulative therapy, nociplastic pain, central sensitization, C-fibers, brain, electroencephalography
Medical subject headings: Nociplastic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lumbar spinal manipulative therapyProcedure or surgery
Also called spinal manipulation, chiropractic adjustment, grade 5 spinal mobilization
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).
sham spinal manipulative therapyProcedure or surgery
Also called control intervention, sham control, sham treatment, placebo
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 high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.
full spine spinal manipulative therapyProcedure or surgery
Also called spinal manipulation, chiropractic adjustment, grade 5 spinal mobilization
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).

Study groups in NCT05986370
Study group	Role	What they receive
lumbar spinal manipulative therapy	Experimental	Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust. Receives: Procedure: lumbar spinal manipulative therapy
full spine spinal manipulative therapy	Experimental	Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust. Receives: Procedure: full spine spinal manipulative therapy
sham spinal manipulative therapy	Sham comparator	Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used: * Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination. * Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s. * Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse. Receives: Procedure: sham spinal manipulative therapy
no intervention	No intervention	This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.

What is being measured

The primary outcome is the main question the study is designed to answer.

low back pain intensity
In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.
Measured: 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
Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.
Measured: baseline, 4- and 12-weeks post-randomization.

Secondary outcomes (14)

low back pain frequency and duration
A modified version of the pain frequency-severity-duration scale will be used. Participants will be instructed to answer these 3 questions:
- Is the pain recurrent (it comes in episodes) or continuous (it is always present)?
- How many days in the past week have you had low back pain? (0, 1, 2, 3, 4, 5, 6, 7 days; a higher score means a worse outcome)
- On average, how many hours per day does the pain last? (0; 1-4; 5-8; 9-12; 13-16; 17-20; 21-24 hours; a higher score means a worse outcome)
Measured: 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)
PPT will be measured using a handheld digital algometer (Wagner Pain TestTM FPX, Greenwich, Connecticut, USA) and a standardized protocol. The algometer will be applied perpendicularly to the skin of the first test location and the pressure increased at approximately 50 kPa/s until pain is reported by the participant. This procedure will be repeated three times at the same test location. The PPT will be the average of the values obtained during these 3 trials. The same procedures will be repeated at the two other test locations. PPT will be tested on three different body locations: 1) Over the spinous process of the most painful vertebra between L1 and S1; 2) On the right lower limb in the dermatome corresponding to the level of the most painful vertebra; 3) in the center of the right thenar eminence.
Measured: baseline, 4- and 12-weeks post-randomization.
C-fiber-related brain responses
Electroencephalography (EEG) will be recorded using a 64-channel BrainVision system with active Ag-AgCl electrodes mounted on an actiCAP, according to the International 10-20 system (Brain Products, Gilching, Germany). Electrodes will be nose-referenced, and the ground will be set at FPz. Signals will be sampled at 500 Hz. Eye movements and blinks will be recorded using electrooculography (EOG). Electrode impedance will be kept below 20 kΩ. Closed eyes resting state EEG will be recorded for 5 min prior to laser stimuli for exploratory EEG analyses. EEG activity will be recorded continuously. The outcome of interest from laser-evoked-brain activity is the response evoked by C-fiber activation. Laser-evoked potentials (LEP) and event-related spectral perturbations (ERSP) will be analyzed using validated methods.
Measured: baseline, 4- and 12-weeks post-randomization.
Oswestry Disability Index (ODI)
Self-reported low back pain related disability will be evaluated using the French-Canadian version of the ODI (0-100%; a higher score means a worse outcome).
Measured: baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.
Back performance scale (BPS)
The BPS will be used as a performance based outcome of physical function. It includes five daily activities such as putting socks on or picking something on the floor (see PMID: 12444880 for more details). Each activity is rated from 0 to 3, and the five scores are added up (min = 0, max = 15; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Five times sit-to-stand test
The five times sit-to-stand test will be used as performance based outcome of physical function. Participant sitting on a supported chair will be instructed to stand and sit again as fast as possible, five times in a row. Time will be measured in seconds. The test will be performed twice and the average time for the two trials will be recorded (a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Depression
Depression levels will be measured using the French-Canadian version of the Beck Depression Inventory (BDI; min = 0, max = 63; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Anxiety
Anxiety levels will be measured using the French-Canadian version of the State-Trait Anxiety Inventory, version Y (STAI-Y; min = 20, max = 80; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Pain catastrophizing
The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain catastrophizing will be measured with the French-Canadian version of the pain catastrophizing scale (PCS; min = 0, max = 52; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Kinesiophobia
The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain-related fear will be measured with a French adaptation of the Tampa scale for kinesiophobia (TSK; min = 17, max = 68; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Pain vigilance
The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Hypervigilance will be measured with a French adaptation of the pain vigilance and awareness questionnaire (PVAQ; min = 0, max = 80; a higher score means a worse outcome).
Measured: baseline, 4- and 12-weeks post-randomization.
Patient's global impression of change
Participants will be instructed to give their global impression of change on a scale from -100 to 100 (-100 = very much worse, 0 = no change, 100 = very much improved).
Measured: After the last treatment session (12-weeks post-randomization)
Expectations of pain relief
Participants will be instructed to rate their expectations of pain relief after the treatment on a scale from 0 to 100, 0 being "no relief" and 100 being "complete relief".
Measured: baseline and 4-weeks post-randomization.
Contextual factors (healing encounters and attitudes lists (HEAL))
Contextual factors will be measured using a French adaptation of the healing encounters and attitudes lists (HEAL).
Measured: baseline, 4- and 12-weeks post-randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 202331 Dec 2026

First posted14 Aug 2023
Study start25 Oct 2023
Primary completion29 Sep 2025 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (41)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 112 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05986370
Sponsor's protocol ID: METRIC
Acronym: METRIC
Status last verified: Dec 2023
First submitted: 26 Jul 2023
Last updated: 4 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After publication of the results, the data that support the findings of this study will be available from the corresponding author, MP, upon reasonable request.

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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 outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 34719942
Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piche M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain. 2021 Aug;25(7):1429-1448. doi: 10.1002/ejp.1773. Epub 2021 Apr 15.
PubMed 33786932
Gevers-Montoro C, Provencher B, Northon S, Stedile-Lovatel JP, Ortega de Mues A, Piche M. Chiropractic Spinal Manipulation Prevents Secondary Hyperalgesia Induced by Topical Capsaicin in Healthy Individuals. Front Pain Res (Lausanne). 2021 Jul 20;2:702429. doi: 10.3389/fpain.2021.702429. eCollection 2021.
PubMed 35295504
Graven-Nielsen T. Mechanisms and manifestations in musculoskeletal pain: from experimental to clinical pain settings. Pain. 2022 Nov 1;163(Suppl 1):S29-S45. doi: 10.1097/j.pain.0000000000002690. Epub 2022 May 15. No abstract available.
PubMed 35984370
Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.
PubMed 26563249
Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
PubMed 24139233
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870
Hohenschurz-Schmidt D, Vase L, Scott W, Annoni M, Ajayi OK, Barth J, Bennell K, Berna C, Bialosky J, Braithwaite F, Finnerup NB, Williams ACC, Carlino E, Cerritelli F, Chaibi A, Cherkin D, Colloca L, Cote P, Darnall BD, Evans R, Fabre L, Faria V, French S, Gerger H, Hauser W, Hinman RS, Ho D, Janssens T, Jensen K, Johnston C, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener LA, Moerman DE, Musial F, Newell D, Nicholas M, Palermo TM, Palermo S, Peerdeman KJ, Pogatzki-Zahn EM, Puhl AA, Roberts L, Rossettini G, Tomczak Matthiesen S, Underwood M, Vaucher P, Vollert J, Wartolowska K, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement. BMJ. 2023 May 25;381:e072108. doi: 10.1136/bmj-2022-072108. No abstract available.
PubMed 37230508

Interested in taking part?

Benjamin Provencher

1-819-376-5011 ext. 4996

metric@uqtr.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05986370
Acronym / sponsor ID: METRIC / METRIC
Conditions: Chronic Low-back Pain
Keywords: chronic primary low back pain, spinal manipulative therapy, nociplastic pain, central sensitization, C-fibers, brain, electroencephalography
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 112 participants (estimated)
Lead sponsor: Université du Québec à Trois-RivièresUniversity, hospital or other
Study start: 25 Oct 2023 (actual)
Primary completion: 29 Sep 2025 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 14 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
lumbar spinal manipulative therapy	Experimental	Procedure: lumbar spinal manipulative therapyParticipants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust.
full spine spinal manipulative therapy	Experimental	Procedure: full spine spinal manipulative therapyParticipants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust.
sham spinal manipulative therapy	Sham comparator	Procedure: sham spinal manipulative therapyParticipants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used: * Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination. * Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s. * Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse.
no intervention	No intervention	–This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lumbar spinal manipulative therapyAlso: spinal manipulation, chiropractic adjustment, grade 5 spinal mobilizationSpinal 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 or surgery	lumbar spinal manipulative therapy
sham spinal manipulative therapyAlso: control intervention, sham control, sham treatment, placeboSham 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 high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.	Procedure or surgery	sham spinal manipulative therapy
full spine spinal manipulative therapyAlso: spinal manipulation, chiropractic adjustment, grade 5 spinal mobilizationSpinal 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 or surgery	full spine spinal manipulative therapy

Primary outcome

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.
In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.
temporal summation of second pain
Time frame: baseline, 4- and 12-weeks post-randomization.
Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.

14 secondary outcomes

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)
Expectations of pain relief
Time frame: baseline and 4-weeks post-randomization.
Contextual factors (healing encounters and attitudes lists (HEAL))
Time frame: baseline, 4- and 12-weeks post-randomization.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Background: PubMed 33090740Buchbinder 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.
Background: PubMed 26447703Cormier 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.
Background: PubMed 33064878Corp 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.
Background: PubMed 32125402Dieleman 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.
Background: PubMed 15621359Dworkin 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 outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
Background: PubMed 35975135Fitzcharles 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.
Background: PubMed 35839253Funabashi 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.
Background: PubMed 34719942George 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.
Background: PubMed 33786932Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piche M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain. 2021 Aug;25(7):1429-1448. doi: 10.1002/ejp.1773. Epub 2021 Apr 15.
Background: PubMed 35295504Gevers-Montoro C, Provencher B, Northon S, Stedile-Lovatel JP, Ortega de Mues A, Piche M. Chiropractic Spinal Manipulation Prevents Secondary Hyperalgesia Induced by Topical Capsaicin in Healthy Individuals. Front Pain Res (Lausanne). 2021 Jul 20;2:702429. doi: 10.3389/fpain.2021.702429. eCollection 2021.
Background: PubMed 35984370Graven-Nielsen T. Mechanisms and manifestations in musculoskeletal pain: from experimental to clinical pain settings. Pain. 2022 Nov 1;163(Suppl 1):S29-S45. doi: 10.1097/j.pain.0000000000002690. Epub 2022 May 15. No abstract available.
Background: PubMed 26563249Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.
Individual participant dataSharing planned: Yes. After publication of the results, the data that support the findings of this study will be available from the corresponding author, MP, upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Benjamin Provencher contact

1-819-376-5011 ext. 4996

metric@uqtr.ca

Mathieu Piché contact

1-819-376-5011 ext. 3998

metric@uqtr.ca

Mathieu Piché principal investigator

Université du Québec à Trois-Rivières

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Provencher (1-819-376-5011 ext. 4996, metric@uqtr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986370, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.