NCT06537739

Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation

Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation of the Lumbar Spine in Patients with Chronic Non-specific Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: John Paul II University in Biała Podlaska · Academic / Other
• Sex: All
• Age: 19 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers. The study participants will be randomly assigned (sealed allocation envelopes) to the following groups: * Group A (test intervention + placebo communication) * Group B (test intervention + nocebo communication) * Group C (test intervention + neutral communication) The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later.

Detailed description

Pain is complex in nature and is closely related to the secretion of biochemical markers such as cortisol, serotonin and oxytocin. Higher levels of inflammatory markers, cytokines and chemokines have been found in patients with low back pain, which ultimately affect the clinical manifestations observed in the patients. One of the methods of physiotherapeutic treatment of spinal disorders involving manual diagnostic and therapeutic techniques is manual therapy. In the therapy, among others, joint manipulation techniques are used. However, the mechanisms underlying the effects of the joint manipulation on the body have not been fully explained. Undoubtedly, one of the main mechanisms of action of manual therapy is pain modulation. In recent years, research has been increasingly focusing on manipulation in a psychological context, including mechanisms of fear-avoidance, pain catastrophizing and kinesiophobia. Furthermore, manipulation can affect immune and endocrine system responses. One of the significant non-specific effects accompanying any medical procedure is a placebo effect. The way health care professionals discuss, describe and inform patients about characteristic symptoms of a given disease its prevention, diagnosis and treatment, influences the patients' feelings and expectations, which in turn affect their psycho-biological reactions, subjective perception and treatment outcomes. The appropriate choice of words by clinicians influences patients' responses to medical treatments and procedures, whether active or sham. The way in which information about the outcome of a treatment is communicated to patients can induce the reinforcing effects of a given treatment (placebo) or reverse the clinically proven effects of an active treatment, or even increase its adverse outcomes in the form of a nocebo effect. The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers. Research questions: 1. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the pain level? 2. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the stress level? 3. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the kinesiophobia level? 4. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the lumbar spine range of motion? 5. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the disability level? 6. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to sleepiness? 7. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the tissue temperature of the lumbar spine region? 8. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the selected blood biochemical markers (cortisol, serotonin and oxytocin)? The participants will be selected for the study from the group of students from John Paul II University in Biała Podlaska, Poland. The participation in the study will be voluntary. The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later. Once, before the intervention, a scale will be used for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology. The other research tools will be used in two stages: an information questionnaire (before the intervention and 24 hours after the intervention) and a scale for the subjective assessment of the treatment outcomes based on the GRoC methodology (immediately after the intervention and 24 hours later).

Conditions

• Back Pain

Interventions

Type	Name	Description
OTHER	Lumbar manipulation	Participant lies in the supine position, a physiotherapist faces the participant's side that will be manipulated. The participant interlocks their fingers behind their neck. Then the physiotherapist turns the participant on their side and performs a short thrust across the participant's pelvis in a posterior and inferior direction. The manipulation will be carried out on the symptomatic side, based on the participant's indication of the painful side. If the participant is unable to indicate the more symptomatic side, the physiotherapist performing the procedure will select the side. If no audible cavitation occurs during the manipulation, the physiotherapist will attempt to manipulate the opposite side. A maximum of 2 attempts per side will be allowed.
OTHER	Positive communication - placebo	Participants from Group A who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is a very effective method of treating spinal disorders, which will significantly reduce the low back pain you are experiencing" (positive communication - placebo).
OTHER	Negative communication - nocebo	Participants form Group B who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is not an effective method of treating spinal disorders, thus it may temporarily increase the low back pain you are experiencing" (negative communication - nocebo).
OTHER	Neutral communication	Participants from Group C who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation has not been verified for its effectiveness in affecting your level of low back pain" (neutral communication).

Timeline

• Start date: 2024-10-14
• Primary completion: 2024-12-16
• Completion: 2025-01-31
• First posted: 2024-08-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: Poland