Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870371
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2022-09-12
Brief Title:
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
Sponsor:
University of West Attica
Organization:
University of West Attica
Study Overview
Official Title:
The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMvsCNP
Brief Summary:
This doctoral thesis is a single blind randomized controlled clinical trial with an active control element The intervention examined in this trial is the Awareness Through Movement ATM technique of the Feldenkrais Method FM while the standard treatment given to the control group is the combination of acupuncture and stretching
The study was designed to examine the extend of the effect of ATM as a means of reduction of pain improvement of functionality and psychosomatic parameters of patients with chronic neck pain in comparison to biomedical acupuncture protocol in combination with stretching
The effectiveness of the intervention will be compared to the effect of the standard treatment a combination of acupuncture and stretching in relation to parameters of pain range of motion of rotation flexion-extension and lateral flexion of the cervical spine and the sense of position kinesthesia the endurance of the cervical deep flexor muscles respiratory function and psychometric characteristics which are evaluated at specific times before and after the intervention-five weeks
During the discussion the results of this study in combination with the degree of validity of the observation will be compared to those of the literature review This comparison could contribute to the more effective clinical application of ATM in the treatment of chronic neck pain either as part of physiotherapeutic rehabilitation or as a unique approach
The study was designed to examine the extend of the effect of ATM as a means of reduction of pain improvement of functionality and psychosomatic parameters of patients with chronic neck pain in comparison to biomedical acupuncture protocol in combination with stretching
The effectiveness of the intervention will be compared to the effect of the standard treatment a combination of acupuncture and stretching in relation to parameters of pain range of motion of rotation flexion-extension and lateral flexion of the cervical spine and the sense of position kinesthesia the endurance of the cervical deep flexor muscles respiratory function and psychometric characteristics which are evaluated at specific times before and after the intervention-five weeks
During the discussion the results of this study in combination with the degree of validity of the observation will be compared to those of the literature review This comparison could contribute to the more effective clinical application of ATM in the treatment of chronic neck pain either as part of physiotherapeutic rehabilitation or as a unique approach
Detailed Description:
Chronic neck pain is a common phenomenon in the adult population with a prevalence of about 15 while it is indicative that 23 of the population will develop neck pain during their lifetime with slight predominance in women In physiotherapy a number of therapeutic techniques are available to treat chronic neck pain Although no obvious single treatment option has been shown to be the most effective systematic reviews show that rehabilitation in a variety of forms has the strongest evidence for the effectiveness of relieving chronic neck pain In these forms complementary therapies such as acupuncture chiropractic yoga Tai Chi as well as sensory-motor approaches such as the Feldenkrais method are incorporated
Contemporary articles found in 6 studies investigate the effect of the Feldenkrais method Feldenkrais MethodFM in chronic neck pain and date between the years 1999-2014 Primary outcome measure was pain while secondary assessed disability functional status and quality of life The findings in the majority showed initial positive indications for the application of FM in the management of chronic neck pain However further high-quality methodological studies are required in order to draw reliable conclusions
This doctoral thesis is a single blind randomized controlled clinical trial with an active control element where the intervention is the Feldenkrais Awareness Through Movement ATM technique and the standard treatment given to the control group is the combination of acupuncture and stretching due to its scientifically proven efficacy and widespread use as the treatment of choice in this pathology
The study was designed to examine whether and to what extent ATM application will reduce pain improve functionality in patients with chronic neck pain and have a positive effect on the psychosomatic parameters of pain firstly as an individual intervention and in comparison with biomedical acupuncture protocol in combination with stretching secondly
The purpose of the study is twofold
i The highlight of indications for statistically significant differences in the mean values of the variables which investigate the pain pressure threshold and objective evaluation of pain Short Form of McGill Pain QuestionnaireSFMPQ functionality Neck Disability IndexNDI range of motion of rotation flexion-extension and lateral flexion of the cervical spine and the sense of position kinesthesia 3D sensor inertial motion MOOVER the endurance of the cervical deep flexor muscles biofeedback stabilizer pressure Chattanooga Stabilizer Biofeedback assessment of respiratory function portable spirometer by MIR MIR Spirodoc and psychometric characteristics Hospital Anxiety and Depression ScaleHADs Tampa Kinesiophobia ScaleTSK_GR SF-12 Health SurveySF-12 Fear-Avoidance Beliefs QuestionnaireFABQ_GR Pain Catastrophizing ScalePCS for group A-FM Intervention Group-IG and group B-acupuncture with stretching Control Group-CGThe measurements will be performed before pre and after post of the application of the ATM technique in order to evaluate the effectiveness of each intervention separately
ii The comparison between the two groups the determination of the values of the above variables before and after during the time period of five weeks in which the two programs will be implemented in parallel
The sample will consist of 160 patients of both sexes aged 19-70 years with diagnosed chronic non-specific neck pain with a duration of pain at least three months before the initial assessment and participation in the study The selection will be made by the method of random sampling within a period of time and the participants will be distributed by simple randomization equal allocation in two equal groups of 80 people each To achieve the objectives of the study 10 sessions will be conducted over a period of five weeks either of the ATM technique intervention group lasting 50 minutes or of biomedical acupuncture in combination with stretching control group 40 minutes 25 minutes acupuncture plus 15 minutes stretching The intensity of the pain will be assessed with an algometer the range of motion of the flexion-extension rotation and lateral flexion and the sense of the position of the neck with 3D sensor inertial motion MOOVER the endurance of the deep neck flexor muscles with a biofeedback stabilizer and the respiratory function with a spirometer In addition the sample will complete a series of questionnaires that elicit information about chronic neck pain and the dysfunction caused by chronic neck pain
The statistical analysis will be performed with the International Business Machines IBM Corporation software
The effectiveness or not of the FM will be highlighted and comparisons will be made between its effect and acupuncture plus stretching in relation to specific parameters that are evaluated at specific times before and after the intervention-five weeks
During the discussion the results of this study will be compared with those of the literature review In combination with the degree of validity of the observation power analysis of this study the literature data will be taken into account and those results will be extracted which could contribute to the more effective clinical application of FM in the treatment of chronic neck pain either as part of physiotherapeutic rehabilitation or as a unique approach
Contemporary articles found in 6 studies investigate the effect of the Feldenkrais method Feldenkrais MethodFM in chronic neck pain and date between the years 1999-2014 Primary outcome measure was pain while secondary assessed disability functional status and quality of life The findings in the majority showed initial positive indications for the application of FM in the management of chronic neck pain However further high-quality methodological studies are required in order to draw reliable conclusions
This doctoral thesis is a single blind randomized controlled clinical trial with an active control element where the intervention is the Feldenkrais Awareness Through Movement ATM technique and the standard treatment given to the control group is the combination of acupuncture and stretching due to its scientifically proven efficacy and widespread use as the treatment of choice in this pathology
The study was designed to examine whether and to what extent ATM application will reduce pain improve functionality in patients with chronic neck pain and have a positive effect on the psychosomatic parameters of pain firstly as an individual intervention and in comparison with biomedical acupuncture protocol in combination with stretching secondly
The purpose of the study is twofold
i The highlight of indications for statistically significant differences in the mean values of the variables which investigate the pain pressure threshold and objective evaluation of pain Short Form of McGill Pain QuestionnaireSFMPQ functionality Neck Disability IndexNDI range of motion of rotation flexion-extension and lateral flexion of the cervical spine and the sense of position kinesthesia 3D sensor inertial motion MOOVER the endurance of the cervical deep flexor muscles biofeedback stabilizer pressure Chattanooga Stabilizer Biofeedback assessment of respiratory function portable spirometer by MIR MIR Spirodoc and psychometric characteristics Hospital Anxiety and Depression ScaleHADs Tampa Kinesiophobia ScaleTSK_GR SF-12 Health SurveySF-12 Fear-Avoidance Beliefs QuestionnaireFABQ_GR Pain Catastrophizing ScalePCS for group A-FM Intervention Group-IG and group B-acupuncture with stretching Control Group-CGThe measurements will be performed before pre and after post of the application of the ATM technique in order to evaluate the effectiveness of each intervention separately
ii The comparison between the two groups the determination of the values of the above variables before and after during the time period of five weeks in which the two programs will be implemented in parallel
The sample will consist of 160 patients of both sexes aged 19-70 years with diagnosed chronic non-specific neck pain with a duration of pain at least three months before the initial assessment and participation in the study The selection will be made by the method of random sampling within a period of time and the participants will be distributed by simple randomization equal allocation in two equal groups of 80 people each To achieve the objectives of the study 10 sessions will be conducted over a period of five weeks either of the ATM technique intervention group lasting 50 minutes or of biomedical acupuncture in combination with stretching control group 40 minutes 25 minutes acupuncture plus 15 minutes stretching The intensity of the pain will be assessed with an algometer the range of motion of the flexion-extension rotation and lateral flexion and the sense of the position of the neck with 3D sensor inertial motion MOOVER the endurance of the deep neck flexor muscles with a biofeedback stabilizer and the respiratory function with a spirometer In addition the sample will complete a series of questionnaires that elicit information about chronic neck pain and the dysfunction caused by chronic neck pain
The statistical analysis will be performed with the International Business Machines IBM Corporation software
The effectiveness or not of the FM will be highlighted and comparisons will be made between its effect and acupuncture plus stretching in relation to specific parameters that are evaluated at specific times before and after the intervention-five weeks
During the discussion the results of this study will be compared with those of the literature review In combination with the degree of validity of the observation power analysis of this study the literature data will be taken into account and those results will be extracted which could contribute to the more effective clinical application of FM in the treatment of chronic neck pain either as part of physiotherapeutic rehabilitation or as a unique approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Research and Ethics Committee | REGISTRY | Medical School - Aretaio Hospital NKUA Greece | None |