Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain

NCT05202704 | Unknown

• 1 other identifier: 52925921.5.0000.5504
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study will be to identify whether a conditioning procedure by the surreptitious 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 spinal manipulative therapy intervention in patients with CLBP. This study will enroll 264 individuals with CLBP aged between 18 and 60 years. Spinal Manipulative Therapy 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. Afterward, 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) expectations 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 means of 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 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 outcome will be low back pain disability.

Conditions

Chronic Low Back Pain

Keywords

Placebo Effect; Contextual Effect; Spinal Manipulative Therapy; Expectations; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Numeric pain rating scale (NPRS)

  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.

  6 weeks after randomization

• Global Perceived Effect (GPE)

  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.

  6 weeks after randomization

Secondary Outcomes (1)

• Oswestry Disability Index (ODI)

  6 weeks and 3 months after randomization

Other Outcomes (8)

• Stanford Expectation Treatment Scale (SETS)

  Baseline

• Low Back Pain Improvement Expectation Scale

  Baseline

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline

Study Arms (3)

Experimental: Hidden conditioning procedure + Positive Expectation

EXPERIMENTAL

Patients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy. Then, after the spinal 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; Procedure: Spinal Manipulative Therapy

Active Comparator: Positive expectations

ACTIVE COMPARATOR

Patients with chronic low back pain will receive verbal delivered positive instructions regarding spinal manipulative therapy (G2) before the administration of a spinal manipulative therapy approach.

Procedure: Procedure/Surgery: Active Comparator: Positive Expectation; Procedure: Spinal Manipulative Therapy

Active Comparator: Neutral Expectations

ACTIVE COMPARATOR

Patients with chronic low back pain will receive verbal delivered neutral instructions regarding spinal manipulative therapy (G3) before the administration of a spinal manipulative therapy approach.

Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation; Procedure: Spinal Manipulative Therapy

Interventions

Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation PROCEDURE

Patients will be submitted to quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectations 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 downgraded to the moderate stimulus - individually obtained during the QST) as a mean to conditioning patients to believe that spinal 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 ensure that the conditioning procedure worked.

Experimental: Hidden conditioning procedure + Positive Expectation

Procedure/Surgery: Active Comparator: Positive Expectation PROCEDURE

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). Afterward, 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 spinal 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.

Active Comparator: Positive expectations

Procedure/Surgery: Active Comparator: Neutral Expectation PROCEDURE

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). Afterward, 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 spinal 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.

Active Comparator: Neutral Expectations

Spinal Manipulative Therapy PROCEDURE

All the groups recruited in the study will receive five sessions of Spinal 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: Neutral Expectations; Active Comparator: Positive expectations; Experimental: Hidden conditioning procedure + Positive Expectation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who report non-specific CLBP (in which the specific nociceptive source cannot be identified, confirmed by a medical assessment) for at least three months duration;
• Age ranged from 18 years to 60 years
• Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error \> 2 reported for the NPRS);
• Score greater than 14% on the Oswestry Disability Index (ODI) (to surpass the smallest detectable change of the ODI total score
• Patients able to speak and understand Portuguese well to fill out the questionnaires.
• Patients will be excluded if they met any of the following criteria:
• Previous poor experiences with SMT through the application of a brief screening questionnaire
• Pregnancy
• Specific low back pain disorders like radiculopathy or lumbar stenosis or chronic degenerative disorders, i.e., uncontrolled cardiovascular, metabolic, or systemic diseases, neurological or psychiatric diseases, and stroke sequelae
• Undergoing other therapeutic interventions for chronic pain and low back pain (including surgeries) in the last 3 months
• Presence of contraindications to SMT
• Patients who reach the upper limit of 50ºC, which is the maximum temperature provided by the Q-sense equipment described in the Medoc, Israel website

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Unidade Saúde Escola - USE

São Carlos, São Paulo, 13.565-905, Brazil

RECRUITING

Related Publications (1)

• Nogueira Carrer HC, Lima TC, George SZ, Reis FJJD, Dias DLC, Campanha BES, Chaves TC. Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial. BMJ Open. 2023 Apr 12;13(4):e066199. doi: 10.1136/bmjopen-2022-066199.

  PMID: 37045570 DERIVED

Study Officials

• Thais Chaves, PhD

  Federal University of São Carlos - UFSCar

  STUDY CHAIR

Central Study Contacts

Thaís C Chaves, PhD

CONTACT

+55 (16) 3602-4694; thaischaves@ufscar.br

Helen N Carrer, PhD

CONTACT

+55 (16) 98163-8793; helencnogueira@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 21, 2022
• Study Start: February 20, 2022
• Primary Completion: December 10, 2023
• Study Completion: March 10, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

BR (1)