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RESEARCH COMMENTARY
Ejona (Ona) Jeblonski, DPT, COMT
Fellow in Training, MAPS Accredited Fellowship in Orthopedic Therapy

Chris R. Showalter, PT, COMT, OCS, FAAOMPT
MAPS Fellowship Program Director

Mobilization Increases Dorsiflexion in Chronic Ankle Instability (CAI) Patients


 
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Even if the patient meets CPR for Low Back Pain Manipulation…you don’t have to thrust! There are NO DIFFERENCES in OUTCOMES when patients received Thrust or Non-Thrust manipulation

December 08, 2014

RESEARCH COMMENTARY

Chris Showalter PT, OCS, COMT, FAAOMPT

MAPS Clinical Director


Full Disclosure: This month’s Research Commentary discusses a number of peer reviewed research articles co-authored by MAPS Research Consultant Chad Cook and MAPS Senior Faculty Members including: Ken Learman, Chris Showalter, Vincent Kabbaz and Bryan O’Halloran, and collaborator Megan Donaldson. 


Even if the patient meets CPR for Low Back Pain Manipulation…you don’t have to thrust!

There are NO DIFFERENCES in OUTCOMES when patients received Thrust or Non-Thrust manipulation


Prior studies have proclaimed the early use of Thrust Manipulation (TM) in Acute Low Back Pain (LBP) as TM has been suggested to improved outcomes and provide quicker recovery. To our knowledge only two prior studies have directly compared TM to Mobilization, also known as Non-Thrust Manipulation, (NTM) (Hadler et al, 1987 and Cleland et al, 2009). These studies both concluded that TM was superior to NTM. Contrary to the Hadler and Cleland studies, our results found NO DIFFERENCES between TM and NTM.


We discuss potential reasons for these different results in detail in our original Research Commentary  posted on October 10, 2012 regarding our RCT "Early use of thrust manipulation versus non-thrust manipulation: A randomized clinical trial.”  See link below.


https://www.ozpt.com/research_commentary_item.php?id=34&wh=hist


IMPORTANT NOTE:  The above October 12, 2012 article has received significant interest around the world. The online attention this study received is in the top 5% of all articles EVER reviewed and discussed online, according to tracking data from the quality measurement tool Almetric.


This month’s Research Commentary discusses another secondary analysis of the original RCT in our recent article “No Differences in Outcomes in People with Low Back Pain Who Met the Clinical Prediction Rule for Lumbar Spine Manipulation When a Pragmatic Non-Thrust Manipulation Was Used as the Comparator” by Kenneth Learman, Chris Showalter, Bryan O’Halloran, Megan Donaldson and Chad Cook (Physiotherapy Canada 2014; 66(4);359-366)


There are three unique features incorporated into the design of these studies, namely:


1)     Control for potential therapist bias

We performed pre-study evaluations of each treating therapist for “personal equipoise” regarding NTM and TM, and hence any pre-conceived therapist bias regarding the relative effectiveness of the interventions. To our knowledge, this is the FIRST STUDY to actively control for this potential for bias when investigating two manual therapy procedures.   


2)     Control for potential patient expectation bias

Patient expectations were also evaluated, prior to treatment, regarding the patient’s perception of the most beneficial treatment approach (NTM or TM). To our knowledge, this is the FIRST STUDY to actively control for this potential for bias when investigating two manual therapy procedures.


3)     Pragmatic design reflects “actual clinical practice”

We designed our pragmatic trial to reflect actual clinical decision-making processes involving manual therapy interventions. As such, our study reflects actual clinical practice in which physiotherapists were allowed to alter their treatment decision-making based upon patient presentation. To our knowledge, this is only the FIRST STUDY to allow unfettered therapist clinical decision making when investigating two manual therapy procedures for LBP. Others (Leaver et al, 2010) have investigated NTM and TM in recent onset neck pain as a pragmatic trial (allowing therapists to modify their treatment). They also found no difference in the NTM or TM, in their study involving neck patients.


Background on Personal Equipoise AND Patient Expectations  


“Clinical and personal equipoise exists when a clinician has no good basis for a choice between two or more care options or when one is truly uncertain about the overall benefit or harm offered by the treatment to his/her patient. For most manual therapy trials, equipoise does not likely exist. Because of the nature of the intervention a lack of equipoise can lead to bias and may account for a portion of the ‘effect’ that has traditionally been assigned to the intervention. Although there are methodological mechanisms to reduce the risk of bias associated with a lack of equipoise, most of the manual therapy trials to date are likely guilty of this form of bias.” (Cook and Sheets 2011)


It has been reported that if personal equipoise is biased toward one procedure, there is a danger that the trial will NOT be properly aimed at maximizing benefits to future patients (Alderson, 1996)  


(Learman 2014) Study Methods


After randomized allocation into the NTM and TM groups, therapists were allowed to determine which actual NTM or TM technique to use to implement the patients treatment for the first two treatment sessions. As treatment progressed, the therapists were allowed to modify treatment based upon their clinical reasoning and the patient’s response to treatment.


A two-way model ANOVA was used for statistical analysis.


Study Results


N = 71 Patients who met the CPR for LBP were extracted from the original larger RCT


There were NO SIGNIFICANT DIFFERENCES (p = 0.55) between the NTM and TM groups in the following outcomes:

  1. Pain and Disability

  2. Total number of visits

  3. Total days in care

  4. Rate of recovery

Within subjects effects were significant for both groups (p < 0.001)


Conclusions:

The (Learman 2014) secondary analysis described above suggests that patients who satisfy the CPR benefit as much from NTM as TM.



8 IMPORTANT TAKE-HOME MESSAGES REGARDING NTM AND TM IN LBP PATIENTS:


1. (Cook 2013) was the FIRST STUDY to show that:

  • Mobilization (NTM) and Manipulation (TM) are EQUALLY EFFECTIVE in PRODUCING the SAME OUTCOMES in Mechanical LBP Patients.

  • In addition, within group changes were significant for both groups 

     

    In other words…mobilization and manipulation produce the same outcomes in mechanical LBP Patients

     

2. (Cook 2013) was also the FIRST STUDY to control for personal equipoise AND patient expectations during the investigation of two manual therapy interventions.  Our control for equipoise and expectations results in substantially increased validity of our findings.

In other words….prior studies that did not control for these significant factors may suffer from bias in terms of their results and conclusions.


3. (Cook 2013) was the FIRST LBP STUDY to reflect actual clinical practice in which physiotherapists were allowed to alter their treatment decision making based upon patient presentation (a pragmatic design). 

In other words...when therapists who use mobilization and manipulation in clinical practice are allowed to mobilize and manipulate according to the patient’s presentation…there is no difference between the two interventions 

4. (Cook 2013) was FIRST STUDY to show that personal equipoise affects study outcome…personal equipoise was significantly associated with ODI and Pain (NPRS).

In other words...failure to control for equipoise (as is the case with prior manual therapy studies) may introduce bias into the study, the results and the subsequent conclusions.


5. (Donaldson 2013) was the FIRST STUDY to show that patient preference/expectation had NO EFFECT on outcomes when thrust or non-thrust interventions were given for mechanical LBP. 

In other words …preference/expectation did NOT affect outcomes.

6. (Learman 2014) was the FIRST STUDY to show that patients who met the criteria for the LBP CPR responded equally well to NTM as to TM.

In other words …if they met the CPR, the patients do EQUALLY well with NTM or TM

7. (Learman 2013) was the FIRST STUDY to show that

  • Mobilization (NTM) and Manipulation (TM) are EQUALLY EFFECTIVE in producing the SAME OUTCOMES (reduced ODI and reduced NPRS) in older subjects with LBP.
  • Within group changes were significant (P<0.001) for reduction in ODI and NPRS for both groups. 

In other words…mobilization and manipulation produce the same outcomes in older subjects with LBP.


8. (Cook 2013) was the FIRST STUDY to show that meeting the CPR for Acute LBP is PROGNOSTIC for mechanical LBP in all 4 of the outcome measures studied (ODI, NPRS, Total Visits, and Report of Rate of Recovery).

In other words…Patients who meet the factors in the CPR will likely get better when given manual therapy treatments.

Stated yet another way, meeting the CPR is a “universal predictor” of a positive outcome following manual therapy in all 4 of the outcome measures used.


IN SUMMARY…Mobilization (NTM) and Manipulation (TM) are EQUALLY EFFECTIVE in LBP patients, including older patients, whether or not they meet the criteria for the prognostic LPB CPR. 



Cheers and Enjoy,

Chris R. Showalter PT, OCS, COMT, FAAOMPT 


© Chris R. Showalter and Maitland Australian Physiotherapy Seminars

Not to be reproduced, copied or retransmitted in any manner without author’s express written permission

Directing others to the MAPS website (www.ozpt.com) is permissible.


Learman 2014 Article Follows


Authors:

Kenneth Learman1, Christopher Showalter2, Bryan O'Halloran3, Megan Donaldson4, Chad Cook4

Purpose: To investigate differences in pain and disability between patients treated with thrust manipulation (TM) and those treated with non-thrust manipulation (NTM) in a group of patients with mechanical low back pain (LBP) who had a within-session response to an initial assessment and met the clinical prediction rule (CPR). Methods: Data from 71 patients who met the CPR were extracted from a database of patients in a larger randomized controlled trial comparing TM and NTM. Treatment of the first two visits involved either TM or NTM (depending on allocation) and a standardized home exercise programme. Data analysis included descriptive statistics and a two-way ANOVA examining within- and between-groups effects for pain and disability, as well as total visits, total days in care, and rate of recovery. Results: No between-group differences in pain or disability were found for NTM versus TM groups (p=0.55), but within-subjects effects were noted for both groups (p<0.001). Conclusions: This secondary analysis suggests that patients who satisfy the CPR benefit as much from NTM as from TM.

Physiotherapy Canada 2014; 66(4);359-366


Where to find the Articles  

 http://www.ncbi.nlm.nih.gov/pubmed/2961085

Hadler NM, Curtis P, Gillings DB, Stinnett S. A benefit of spinal manipulation as adjunctive therapy for acute low-back pain: a stratified controlled trial. Spine (Phila Pa 1976). 1987 Sep;12(7):702-6


 http://www.ncbi.nlm.nih.gov/pubmed/19940729

Cleland JA, Fritz JM, Kulig K, Davenport TE, Eberhart S, Magel JChilds JD. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: a randomized clinical trial. Spine (Phila Pa 1976). 2009 Dec 1;34(25):2720-9.

http://www.manualtherapyjournal.com/article/S1356-689X(12)00189-0/abstract

Chad Cook, Kenneth Learman, Chris Showalter, Vincent Kabbaz, Bryan O’Halloran Early use of thrust manipulation versus non-thrust manipulation: A randomized clinical trial Manual Therapy 2013 Jun 18(3);191-198


Hyperlink not yet available

Kenneth Learman, Chris Showalter, Bryan O’Halloran, Megan Donaldson, Chad Cook.     No Differences in Outcomes in People with Low Back Pain Who Met the Clinical Prediction Rule for Lumbar Spine Manipulation When a Pragmatic Non-Thrust Manipulation Was Used as the Comparator. Physiotherapy Canada 2014; 66(4);359-366


 http://www.ncbi.nlm.nih.gov/pubmed/20801246

Leaver AM, Maher CG, Herbert RD, Latimer J, McAuley JH, Jull GRefshauge KM. A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain. Arch Phys Med Rehabil. 2010 Sep;91(9):1313-8.


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3172958/

Cook CE, Sheets C. Clinical equipoise and personal equipoise: two necessary ingredients for reducing bias in manual therapy trials. JMMT, Volume 19, Number 1, 2011, pp. 55-57(3)


 http://www.ncbi.nlm.nih.gov/pubmed/8798934 

Alderson P. Equipoise as a means of managing uncertainty: personal, communal and proxy. J Med Ethics. 1996 Jun;22(3):135-9.


 http://www.jmptonline.org/article/S0161-4754%2813%2900076-6/abstract

Donaldson M, Learman K, O’Halloran B, Showalter C, Cook CT he Role of Patients' Expectation of Appropriate Initial Manual Therapy Treatment in Outcomes for Patients With Low Back Pain JMPT 2013 Jun 36(5);276-283


http://www.jmptonline.org/article/S0161-4754%2813%2900066-3/abstract

Learman K, Showalter C, O’Halloran B, Cook C Thrust and Nonthrust Manipulation for Older Adults With Low Back Pain: An Evaluation of Pain and Disability JMPT 2013 36(5);284-291


http://www.ncbi.nlm.nih.gov/pubmed/22879443

Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40.







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