Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537739
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie before the intervention immediately after the intervention and 24 hours later
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 ie 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None