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Boosting the Hypoalgesic Effects of Spinal Manipulative Therapy in Chronic Low Back Pain: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT05202704
Recruitment Status : Not yet recruiting
First Posted : January 21, 2022
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Thais Chaves, Universidade Federal de Sao Carlos

Brief Summary:

The objective of this study will be to identify whether a conditioning procedure by surreptitiously downgrade of a noxious stimulus intensity associated with induced positive expectations about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (positive expectation induction) alone regarding the effects of manipulative therapy intervention in patients with CLBP. This study will enroll 264 individuals with CLBP aged between 18 and 65 years. MP in the lumbar spine will be administered to all participants during 5 sessions.

First assessment session - participants will be submitted to a quantitative sensory testing (QST) to determine the heat pain threshold (calibration test) to run the conditioning procedure. Afterwards, participants will be allocated by a blinded researcher into the following subgroups: hidden conditioning + positive expectation (G1); positive expectation alone (G2) and a group submitted to neutral expectations (G3) about the treatment.

First treatment session - Firstly, participants will receive instructions with the aim to induce positive (or neutral) expectation by means of a workshop. Secondly, all the participants will be submitted again to the pre-conditioning test, using the more intense pain stimulus obtained in the calibration test, then patients will be assessed regarding pain intensity and finally submitted to the manipulative therapy. At the end of the first treatment session, the conditioning test will be repeated, but the heat pain threshold of the hidden conditioning group (G1) will be surreptitiously downgraded (from intense pain stimulus to moderate pain stimulus) as a mean to conditioning patients to believe that manipulative therapy promoted pain relief. Pain intensity will be assessed again to confirm a decrease in pain intensity.

Outcomes will be assessed at three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcomes will be low back pain disability.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation Procedure: Procedure/Surgery: Active Comparator: Positive Expectation Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation Procedure: Manipulative Therapy Not Applicable

Detailed Description:

Background: The term "contextual effect" has been used to reinforce the view that the placebo effect should be understood as an effect related to the therapeutic context, and not restricted to the use of inert treatments. Thus, the placebo effect is inherent to any therapeutic context and also can be used to enhance the effects of treatment with active components. There is evidence of the effectiveness of manipulative therapy in the treatment of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect is small. Thus, strategies to enhance the effects of this therapy, such as through the use of context factors, may contribute to better therapeutic outcomes. The literature describes conditioning or positive induced expectation models to favor the placebo effect. Although some previous studies have shown that expectation alone or associated with conditioning procedures may intensify hypoalgesic effects of therapies, no previous work has verified the isolated or associated hypoalgesic effect of conditioning and induction of expectancy on treatment in patients with CLBP undergoing manipulative therapy. Thus, the objective of this study will be to identify whether a conditioning procedure through surreptitiously downgrade of nociceptive stimulus intensity associated with positive induced expectation about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (expectations) induced or expectation alone regarding the effects of Manipulative Therapy intervention in patients with CLBP. Methods: it will be a randomized clinical trial with blinded assessor. It will be investigated the effect of the use of a hidden conditioning procedure and the induction of positive expectation on pain intensity after the administration of a manipulative therapy approach. We will enroll 264 patients with nonspecific CLBP aged 18 to 65 years will participate in this study. The sample size calculation was based on a minimal difference between groups of 2 units on pain intensity and overall perception of improvement (primary outcomes). All patients will undergo 5 sessions of Manipulative Therapy in the lumbar spine, except the no treatment group (G3). In the first session, patients will be subjected to the inclusion and exclusion criteria and the calibration test (quantitative sensory testing) to determine the intense, moderate and weak thermal pain threshold, using the Q-sense equipment (Medoc), for the conditioning procedure.

In the second session (beginning of the treatment), firstly the patients will be randomized to one of the three groups by a blinded assessor: hidden conditioning + positive expectations (G1) group; positive expectations group (G2) and neutral expectation group (G3). Following, participants will receive specific instructions to induce expectation in G1 and G2, and for G3, neutral instructions.

In the first treatment session - patients will receive the pre-conditioning test (heat pain), then they will be submitted to the manipulative therapy and again undergo the heat-conditioning post-testing. However, G1 will receive hidden conditioning (surreptitiously downgrade of noxious stimulus intensity from intense to moderate pain) to reinforce the association between manipulative therapy and pain intensity reduction. Pain intensity will be assessed just after the conditioning procedures as a manipulation check of the downgrading of the noxious stimulus.

The main hypothesis of this study is that the group undergoing hidden conditioning associated with positive induced expectation will have a higher hypoalgesic effect than the other groups immediate post treatment.

Outcomes will be assessed at three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcomes will be low back pain disability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Boosting the Hypoalgesic Effects of Spinal Manipulative Therapy Using Conditioning and Positive Expectation in Chronic Low Back Pain
Estimated Study Start Date : February 20, 2022
Estimated Primary Completion Date : December 10, 2023
Estimated Study Completion Date : March 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Experimental: Hidden conditioning procedure + Positive Expectation
Patients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy. Then, after the manipulative therapy they will be submitted to a hidden conditioning procedure in which the pain threshold will be surreptitiously downgrade to conditioning pain decrease to manipulative therapy (G1).
Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation
Patients will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterwards, participants will receive instructions with the aim to induce positive expectation about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST but now the heat pain threshold of the hidden conditioning group will be surreptitiously downgraded (the intense noxious stimulus will be downgrade to the moderate stimulus - individually obtained during the QST) as a mean to conditioning patients to believe that manipulative therapy promoted pain relief. Patients will be invited to report the pain intensity perceived just after the QST (second test - conditioning procedure). The objective of questioning the pain intensity after the conditioning test is a procedure check - to make sure that the conditioning procedure worked.

Procedure: Manipulative Therapy
All the groups recruited in the study will receive five sessions of Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine.The patients will receive 4 maneuvers (twice towards right side and twice towards left side).

Active Comparator: Active Comparator: Positive expectations
Patients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy (G2) before the administration of a manipulative therapy approach.
Procedure: Procedure/Surgery: Active Comparator: Positive Expectation
Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterwards, participants will receive instructions with the aim to induce positive expectation about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate whether the positive instructions will show any effect.

Procedure: Manipulative Therapy
All the groups recruited in the study will receive five sessions of Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine.The patients will receive 4 maneuvers (twice towards right side and twice towards left side).

Active Comparator: Active Comparator: Neutral Expectations
Patients with chronic low back pain will receive verbal delivered neutral instructions regarding manipulative therapy (G3) before the administration of a manipulative therapy approach.
Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation
Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterwards, participants will receive instructions with the aim to induce neutral expectation about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate/confirm the effect of neutral instructions.

Procedure: Manipulative Therapy
All the groups recruited in the study will receive five sessions of Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine.The patients will receive 4 maneuvers (twice towards right side and twice towards left side).




Primary Outcome Measures :
  1. Pain intensity: Numeric pain rating scale (NPRS) [ Time Frame: 6 weeks after randomization ]
    The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.

  2. Participant ratings of Global Perceived Effect - GPE [ Time Frame: 6 weeks after randomization ]
    The GPE of improvement used for this trial is an 11-point scale that ranges from - 5 ("vastly worse") through 0 ("no change") to + 5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your orofacial pain these days?". A higher score indicates higher perception of recovery from the condition (Costa et al., 2008).


Secondary Outcome Measures :
  1. Pain intensity: Numeric pain rating scale (NPRS) [ Time Frame: 3 months after randomization ]
    The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.

  2. Participant ratings of Global Perceived Effect - GPE [ Time Frame: 3 months after randomization ]
    The GPE of improvement used for this trial is an 11-point scale that ranges from - 5 ("vastly worse") through 0 ("no change") to + 5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your orofacial pain these days?". A higher score indicates higher perception of recovery from the condition (Costa et al., 2008).

  3. Low Back Pain Related Disability [ Time Frame: 6 weeks and 3 months after randomization ]
    Oswestry Disability Index (ODI)The ODI consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, ranging from 10 to 50. This sum will be transformed into a percentage (0 to 100). High scores mean worse disability.


Other Outcome Measures:
  1. Stanford Expectation Treatment Scale (SETS) [ Time Frame: Baseline ]
    The scale contains six questions and seven answer alternatives, ranging from strongly disagree, partially disagree, slightly disagree, neither agree nor disagree, slightly agree, partially agree, and entirely agree to strongly disagree, partially disagree, slightly agree, partially agree, and fully agree. The positive expectation domain must include the total of items 1, 3 and 5 (score ranging from 7-21), while the negative expectation domain must include the sum of questions 2, 4 and 6 (score ranging from 7-21).

  2. Low Back Pain Improvement Expectation Scale [ Time Frame: Baseline ]
    The Scale evaluates a patient's past estimate that his or her low back pain would get better (regardless of the treatment used)."What are the chances of receiving relief from low back pain?" the participant will be asked.The participant will be given an 11-point scale to answer on, with 0 representing "no possibility" and 10 representing "extremely probable" (Eklund et al, 2019).

  3. Hospital anxiety and depression scale (HADS) [ Time Frame: Baseline ]
    HADS will be employed to identify anxiety and depression. It was translated and validated into Brazilian Portuguese. The HADS is divided into the anx- iety subscale (HADS-A) and the depression subscale (HADS-D), both containing seven interspersed items. It is composed of seven items for depression and seven items for anxiety, each item including four response options ranging from 0 to 3. A cutoff of ≥8 was described with good sensitivity and specificity values (0.70-0.90) for anxiety and depression symptoms (Bjelland et al., 2002).

  4. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline ]
    PCS is a self-administered questionnaire that consists of 13 items for the assessment of catastrophizing thoughts. It is divided into three domains: helplessness, magnification, and rumination. Each item is scored on a 5-point ordinal scale. The B-PCS total score ranges from 0 to 52 points, higher values denote greater pain catastrophizing. Acceptable values for validity, internal consistency, and test-retest reliability are described for the Brazilian PCS (Sehn, et al., 2012).

  5. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Baseline ]
    TSK is a self-report questionnaire that assesses the fear of movement through 17 items that address pain and symptom intensity. The scores for each item range from 1 to 4 points (1 point for "strongly disagree", 2 points for "partially disagree", 3 points for "agree" and 4 points for "strongly agree"). For the total score, it is necessary to invert the scores of questions 4, 8, 12 and 16. The final score can range from 17 to 68 points, higher scores represent stronger beliefs about fear of movement (Siqueira et al., 2007).



Information from the National Library of Medicine

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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:

  • Age between 18 to 60 years;
  • Current episode of CLBP lasting more than 3 months (including cases with pain in the lower limbs);
  • Seeking primary clinical care for at least 6 weeks ago for this episode of low back pain;
  • Primary pain located between T12 and the gluteal folds;
  • Pain intensity equal to or greater than 3 on the 0-10 numerical pain rating scale;
  • Score greater than 14% on the Oswestry Disability Index;
  • And be able to speak and understand Portuguese well to complete the questionnaires.

Exclusion Criteria:

  • Patients who report bad previous experiences with manual therapy through the application of a brief screening questionnaire (Colloca et al 2006),
  • Pregnant
  • Uncontrolled cardiovascular systemic, neurological or psychiatric diseases
  • Stroke sequel
  • Unbalanced diabetes
  • Patients undergoing other therapeutic interventions in the last 3 months
  • Patients with no recommendation to manipulative therapy
  • Patients who reach 50 degrees Celsius (the maximum temperature made available by the Q-sense equipment (Medoc), given that 50 degrees Celsius is the device's maximum safety limit for preventing burns to volunteers' skin.
  • Classification in red flags (neoplastic diseases or tumors in the spine,inflammatory diseases, infections and fractures)

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): NCT05202704


Contacts
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Contact: Thaís C Chaves, PhD +55 (16) 3602-4694 thaischaves@ufscar.br
Contact: Helen N Carrer, PhD +55 (16) 98163-8793 helencnogueira@yahoo.com.br

Sponsors and Collaborators
Universidade Federal de Sao Carlos
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Chair: Thais Chaves, PhD Federal University of São Carlos - UFSCar
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Responsible Party: Thais Chaves, Associate Professor, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT05202704    
Other Study ID Numbers: 52925921.5.0000.5504
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022

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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 Thais Chaves, Universidade Federal de Sao Carlos:
Placebo Effect
Contextual Effect
Manipulative Therapy
Expectancy
Chronic Pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations