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What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial (POPS)

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ClinicalTrials.gov Identifier: NCT04086667
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Berit Schiøttz-Christensen
Søren O'Neill
Gregory Kawchuk
Information provided by (Responsible Party):
Casper Glissmann Nim, Spine Centre of Southern Denmark

Brief Summary:

Introduction Several treatment methods have been proposed to ease the burden of low back pain (LBP) but none are clearly superior. Spinal manipulative therapy (SMT) is a guideline recommended treatment, but the effect is moderate to low. Previous publications suggest that acute LBP patients with who are more stiff are more likely to improve with SMT. However, as LBP persists changes in the central nervous system which modulates the pain experience becomes hypersensitive and possible stiffness is not as important an factor. Experimentally SMT may have a reversible effect of this sensitization.

Objective The primary objective of this study is, to examine whether SMT is more effective in regards to short term pain relief when directed at level in the lower back characterized by spinal stiffness or pain hypersensitivity in persistent LBP.

Methods A double blinded randomized clinical trial of up to 155 participants with persistent LBP included at a multidisciplinary Spinecenter. spinal stiffness (Global Stiffness Score) is measured using the VerteTracker, a novel device that can quantify stiffness. Pain sensitivity is measured as pain threshold, tolerance, temporal summation (TS) and conditioned pain modulation(CPM).

Participants receive SMT at either "the stiffest" or "the most sensitive" segment, a total of four times over a 14-day period. The quantitative measures are recorded at baseline, post treatment and at 4-weeks follow-up along with a numerical pain rating (NRS) and the a disability index (ODI).

Discussion These novel findings could improve clinical decision rules - specifically at which level in the lower back to direct SMT. Furthermore, the results will potentially shed light on the underlying mechanisms of SMT - are treatment effects mediated primarily by changes in stiffness or central hypersensitivity?


Condition or disease Intervention/treatment Phase
Low Back Pain Pain, Chronic Other: Spinal manipulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Segments chosen for intervention The most painful segment will be chosen from the MPA findings and the stiff segment from VT.

It is possible to measure the absolute values of both, but it might be that there is a natural difference between segments, especially for stiffness.

Therefore, the stiffness and pain sensitivity for each individual (0-100%) will be normalized. For each segment we calculate the normalized difference:

norm_diff(segment) = (segment_indent - min_indent) / (max_indent - min_indent) - (segment_pain - min_pain) / (max_pain - min_pain) This will determine the biggest difference between stiffness and pain sensitivity and each segment will be chosen according to this. The lowest limit would equal the stiffest segment, while the highest limit would indicate the most painful segment.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Pain group
The segment on the lower back marked as "most painful"
Other: Spinal manipulation
Spinal manipulation: The patient is placed in the side-position and a standard manipulation lumbar-roll technique will be applied at the indicated segment dependent on the subgroup indication.

Experimental: Stiff group
The segment on the lower back marked as "most stiff"
Other: Spinal manipulation
Spinal manipulation: The patient is placed in the side-position and a standard manipulation lumbar-roll technique will be applied at the indicated segment dependent on the subgroup indication.




Primary Outcome Measures :
  1. Subjective low back pain [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]

    Pain: will be measured by the Low Back Pain Rating scale (NRS) consisting of an 11-point box score.

    Changes in pain will be measured at each time point



Secondary Outcome Measures :
  1. Disability [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]

    Disability: will be measured with the Oswestry disability index, which is a 10 item-score with 5 possible answers, a frequency is calculated ranging from [0-100], 100 meaning more disabled.

    Changes in disability will be measured at each time point Changes in pain will be measured at each time point


  2. Low back stiffness (Global stiffness) [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]
    Stiffness will be measured with the VerteTracker. It will output a ratio of the stiffness coefficient for each segment, named "Global Stiffness". Changes in global stiffness will be measured at each time point

  3. Low back pressure pain threshold [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]
    Pressure pain threshold: Will be measured using the pressure algometer, which applies a constant pressure of 50 kPa, until the initial pain perception is felt by the participant. Changes in pressure pain threshold will be measured at each time point

  4. Quantitative sensory testing [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]
    A complete Quantitative sensory pain testing battery will also be measured at each time point. This is measured using cuff algometry on the lower extremity and consists of pressure pain threshold, pressure pain tolerance, conditioned pain modulation and temporal summation. Changes in these pain scores will be measured at each time point.

  5. Heat pain threshold [ Time Frame: Baseline (day 0), Post treatment(day 14), Follow-up(28 days) ]
    Heat pain threshold: Will be measured using the a heat thermode, which applies a constant increase in temperature, until the initial pain perception is felt by the participant. Changes in heat pain threshold will be measured at each time point


Other Outcome Measures:
  1. Intervention information [ Time Frame: Session 1(Baseline/day 0), session 2(Ultimo - week 1), session 3(Primo week 2), session 4(post treatment/dasy 14) ]
    The treating chiropractor will record the following at each treatment session: Adverse effects since last visit, did cavitation occur during the manipulation, was it a successful treatment.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be enrolled in the study, the participant must fulfill the following:

  • Informed written consent
  • Have the ability to speak and read Danish.
  • Between the age of 18 and 60.
  • Body mass index < 35
  • LBP > 3 months, defined as pain on the posterior aspect of the body between the 12th thoracic vertebrae and the gluteal folds.
  • No previous back surgery and must not have had surgery in general in the last 4 months.
  • Must not have received spinal manipulation in the last month.
  • Must not take other pain medication than paracetamol, NSAIDs or weak synthetic opioids
  • Not have radiculopathy: dermatomal leg pain and a positive straight-leg-raise test <60 degrees.
  • Not have problems regarding deep vein thrombosis, circulatory issues in the under extremity, compartment syndrome or severe lung diseases
  • No competing diagnoses which could a) confound the diagnosis of NSLBP e.g. osteoporosis, cancer, fibromyalgia etc. b) interfere with the allocated treatment or c) interfere with QST and VT testing

Exclusion Criteria:

Participants will be excluded during the study if:

  • Not completing the allocated intervention (minimum 75% of scheduled treatments).
  • Receiving other treatment than that administered as part of the study
  • Deviate from the agreed upon medication at baseline measures within the treatment period.
  • Inability to hold breath for 10 seconds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086667


Locations
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Denmark
Spine Centre of Southern Denmark
Middelfart, Denmark, 5500
Sponsors and Collaborators
Spine Centre of Southern Denmark
Berit Schiøttz-Christensen
Søren O'Neill
Gregory Kawchuk
Investigators
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Study Director: Berit Schiøttz-Christensen, PhD Professor

Publications:
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].

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Responsible Party: Casper Glissmann Nim, MSc, Ph.D student, Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT04086667     History of Changes
Other Study ID Numbers: POPS
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be made available if an agreed upon contract can be made and upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Ultimo 2021 and for 5 years
Access Criteria: Permission

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Casper Glissmann Nim, Spine Centre of Southern Denmark:
LBP
SMT
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms