Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain
Unknown statusNot applicableNCT05202704
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 lat…
Study details
- Official title
- Investigating the Hypoalgesic Effects of Spinal Manipulative Therapy Using Hidden Pain Conditioning and Positive Expectation in Chronic Low Back Pain Patients: Protocol for a Randomized Controlled Trial
- Conditions
- Interventions
- Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation
- Procedure: Procedure/Surgery: Active Comparator: Positive Expectation
- Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation
- Procedure: Spinal Manipulative Therapy
- Sponsor
- Universidade Federal de Sao Carlos
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Start date
- 2022-02-20
- Primary completion
- 2023-12-10
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: The inclusion criteria for patients were as follows: 1. 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; 2. Age ranged from 18 years to 60 years 3. Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error \> 2 reported for the NPRS); 4. Score greater than 14% on the Oswestry Disability Index (ODI) (to surpass the smallest detectable change of the ODI total score 5. 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: 1. Previous poor experiences with SMT through the application of a brief screening questionnaire 2. Pregnancy 3. 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 4. Undergoing other therapeutic interventions for chronic pain and low back pain (including surgeries) in the last 3 months 5. Presence of contraindications to SMT 6. 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05202704