The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain

Neck Pain Clinical Trial

— FMvsCNP  

Official title:

The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05870371
• Other study ID #: 103276/18-12-2020
• Secondary ID: Research and Eth
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: University of West Attica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic neck pain is a common phenomenon in the adult population with a prevalence of about 15%, while it is indicative that 2/3 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 Method/FM) 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 Questionnaire/SFMPQ), functionality (Neck Disability Index/NDI), 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 Scale/HADs, Tampa Kinesiophobia Scale/TSK_GR, SF-12 Health Survey/SF-12, Fear-Avoidance Beliefs Questionnaire/FABQ_GR, Pain Catastrophizing Scale/PCS) for group A-FM (Intervention Group-IG) and group B-acupuncture with stretching (Control Group-CG).The 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 30, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic non-specific neck pain

• The duration of the symptoms should be at least three months before the initial evaluation and their participation in the study.

• Existence of reported symptoms of non-rheumatic etiology on the shoulder or upper extremity.

• Age range 19-70 years.

Exclusion Criteria:

• History of surgery in Cervical Spine (Dibai-Fihlo et al. 2017)

• Patients with a history of neck fracture or injury (Campa-Moran et al. 2015, Dibai-Fihlo et al. 2017) in the last year

• Surgery on the head, face or neck (Dibai-Fihlo et al. 2017)

• Active cervical hernia with radical symptoms or severe degenerative diseases in Cervical Spine (Dibai-Fihlo et al. 2017)

• Systemic diseases (diagnosed rheumatic, metabolic and immune diseases), (Edward & Knowles 2003, Wilke et al. 2014, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016 Dibai-Fihlo et al. 2017, Cerezo -Téllez et al. 2018)

• Myelopathy with severe disc or bone damage (Ma et al., 2010, Campa-Moran et al. 2015)

• Cervical rhizitis / rhizopathy (Ma et al. 2010, Wilke et al. 2014, Campa-Moran et al. 2015)

• Arterial dysfunction (Kerry et al. 2008)

• Tumors active during the last five years

• Lymphadenopathy (Tsakitzidis et al. 2013)

• History of inflammatory arthritis (Tsakitzidis et al. 2013)

• Diagnosed psychiatric illness (Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)

• Severe neurological disorder (Edward & Knowles 2003, Wilke et al. 2014) or mental retardation (Ma et al. 2010)

• Signs, Symptoms or History of Mouth Pain and Temporomandibular Disorders Based on the Research Diagnostic Criteria of Temporomandibular Disorders (RDC / TMD) (Campa-Moran et al. 2015)

• Fibromyalgia syndrome diagnosed (Ma et al. 2010, Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018) Infection or inflammatory swelling in the treated area

• Skin damage (Edwards & Knowles 2003) or wounds in the area of the piercing (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)

• Systematic intake of medications that may affect the patient's judgment (eg neuromodulators, antidepressants)

• Taking systemic treatment for the same problem (Wilke et al. 2014) up to three months before the study

• Pregnancy (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)

• Previous Adverse Acupuncture Reaction (Edwards & Knowles 2003)

• Allergy to metal (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)

• Fear of the needle (Edwards & Knowles 2003, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)

• Inability to express speech and writing in the Greek language

Related Conditions & MeSH terms

• Neck Pain

Intervention

Behavioral:
• Feldenkrais Awareness Through Movement technique
10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
• Acupuncture
10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and systematic or general acupuncture points that modify pain behavior in area of Cervical Spine.
• Stretching
10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae, and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalenes, extensors of the Cervical Spine (splenoid, spinous, semispinalis, longus cephalic and cervical, iliocostalis cervical, multifidus and subscapularis), and sternocleidomastoid.

Locations

Country	Name	City	State
Greece	Aretaio Hospital	Athens	Attica
Greece	Laboratory of Musculoskeletal Physiotherapy, University of West Attica	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Pressure Threshold measured by the Commander Algometer, JTECH Medical, Midvale, Utah.	The selected algometer (Commander Algometer, JTECH Medical, Midvale, Utah) is used in the primary measurement regarding the assessment of pain sensation (physiological measurement) to detect the pressure that causes painful symptoms (threshold) when performing the neurodynamic test of the median nerve between patients with unspecified neck pain and asymptomatic patients. The pain recording is performed at specific points with 3 measurements taken at each. The first measurement is considered tentative and is rejected and the final value results from the average of the two remaining measurements.	3 times at baseline
Secondary	Range of Motion measured by the 3D inertial motion sensor MOOVER by SENSOR medica Technology in Motion	The 3D inertial motion MOOVER sensor of the company SENSOR medica Technology in Motion is used to record range of motion by evaluating movements, accelerations and turns.; The sensor is correctly put on each patient's forehead along by their eyebrow line. Patients are seated with their back straight and their chin parallel to the floor while looking at a target corresponding to their field of view. They are then asked to perform three cervical movements for 3 times each with a pause at each final position: left-right rotation, left-right lateral inclination, flexion-extension. Throughout the process, the examiner's assistant carefully stabilizes the patient with their hands on their shoulder girdle and thorax and encourages their constant continuing of each movement. The first measurement is probationary and is not counted in the average score.	Baseline and 5 weeks
Secondary	Kinesthesia measured by the 3D inertial motion sensor MOOVER by SENSOR medica Technology in Motion	The 3D inertial motion MOOVER sensor of the company SENSOR medica Technology in Motion is used to record kinesthesia by evaluating movements, accelerations and turns.; The sensor is correctly put on each patient's forehead along by their eyebrow line. Patients are seated with their back straight and their chin parallel to the floor while looking at a target corresponding to their field of view. They are then asked to perform three cervical movements for 3 times each with a pause at each final position: left-right rotation, left-right lateral inclination, flexion-extension. Throughout the process, the examiner's assistant carefully stabilizes the patient with their hands on their shoulder girdle and thorax and encourages their constant continuing of each movement. The first measurement is probationary and is not counted in the average score.	Baseline and 5 weeks
Secondary	Forced Vital Capacity (FVC) measured by MIR Spirodoc	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) is used. The process involves the measurement of Forced Vital Capacity (FVC).; Each patient is given a sterilized nozzle. They are then asked to seal it with their lips and breathe normally through it while their nasal airway is blocked with the use of a clip. Patients inhale slowly and deeply through the nozzle. Once their lungs are fully filled up with air, they are encouraged to exhale explosively for a minimum duration of 6 seconds.	Baseline and 5 weeks
Secondary	Vital Capacity/Slow Vital Capacity (VC/SVC) measured by MIR Spirodoc	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) is used. The process involves the measurement of Vital Capacity/Slow Vital Capacity (VC/SVC).; Each patient is given a sterilized nozzle. They are then asked to seal it with their lips and breathe normally through it while their nasal airway is blocked with the use of a clip. Patients inhale slowly and deeply through the nozzle. Once their lungs are fully filled up with air, they are encouraged to exhale slowly and extensively until the lungs are fully emptied.	Baseline and 5 weeks
Secondary	Maximum Voluntary Ventilation (MVV) measured by MIR Spirodoc	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) is used. The process involves the measurement of Maximum Voluntary Ventilation (MVV).; Each patient is given a sterilized nozzle. They are then asked to seal it with their lips and breathe normally through it while their nasal airway is blocked with the use of a clip. This test contains a rhythmical and fast rotation of deep inhalations and exhalations until a distinctive auditory signal is sounded after 15 seconds.	Baseline and 5 weeks
Secondary	Endurance of deep flexor muscles of the spine measured by Chattanooga Stabilizer Biofeedback Pressure (PRESSURE BIOREACTION STABILIZER )	The stabilizer assesses the endurance of deep flexor muscles of the spine using the Cranio-Cervical Flexion Test (CCF Test). The changing pressure will be recorded in an air-filled pressure cell, which is connected to a combined guide and plier. The sack is filled up with air until the 20 mmHg indication is shown. There are 5 levels of motion corresponding to a range of 20-30 mmHg of pressure (Level 1: 22 (decreased endurance), Level 2:24, Level 3: 26, Level 4: 28, Level 5:30 (increased endurance)) with a 30-second break in between. Contraction in each level lasts for 10 seconds. If the patient is unable to endure their position for this amount of time in each level, the test is terminated. The efficiency index is calculated as the quotient where the numerator records the pressure increase in the chamber and the denominator the number of repetitions. The maximum applied pressure sustained for a period of ten seconds is defined as the degree of activation.	Baseline and 5 weeks
Secondary	Global Perceived Effect measured by the Global Perceived Effect Scale	The scale assesses the change in patients' pain status compared to how it was before the treatments.; Values range between 1-5 with the higher score indicating worse outcome.	Baseline and 5 weeks
Secondary	Hospital Anxiety and Depression measured by the Hospital Anxiety and Depression Scale/HADs	It is a self-report scale of 14 items, which are rated on a four-point scale numbered 0-3.; It has two subscales, HADs_anxiety and HADs_depression, each of which contains seven items. The total score ranges from 0-21 for each subscale, where values 0-7 correspond to normal depression/anxiety, 8-10 to borderline abnormal, and 11-21 to abnormal.	Baseline and 5 weeks
Secondary	Neck Disability measured by the Neck Disability Index	It consists of ten items where each item corresponds to six answers from which the patient must choose only one. The lowest score for each item is zero which is assigned as no pain and no functional limitation and the maximum five which refers to the worst pain and maximum limitation. It is therefore understandable that the total score ranges from zero to fifty, with values 0-4 (0%-8%) corresponding to no disability, 5-14 (10%-28%) to mild disability, 15-24 (30%-48%) in moderate disability, 25-34 (50%-68%) in severe and 35-50 (70%-100%) absolute disability.	Baseline and 5 weeks
Secondary	Kinesiophobia measured by the Tampa Scale Kinesiophobia	Consists of a 17-item questionnaire with a score of 17-68. Four values correspond to each of the 17 questions: 1=Strongly disagree, 2=Disagree to some extent, 3=Agree to some extent, 4=Strongly agree, while the total score is obtained after reversing questions 4, 8, 12 and 16. If the latter amounts to 37 or less then it is associated with a low fear of movement, while on the contrary, 37 or more, with an increased one.	Baseline and 5 weeks
Secondary	Health Overview measured by the Short Form (SF)-12 Health Survey.	The SF-12 is the short form of the SF-36 which contains 12 out of 36 questions. It assesses with the use of two items the parameters physical functioning (PF), physical and emotional role (role physical/RP, role emotional/RE) and mental health (MH). The parameters bodily pain (BP), general health (GH), social functioning (SF) and vitality (VT) are controlled by one object each. In general, physical (PCS) and mental (MCS) Component Summary health status is assessed in conjunction with overall health-related quality of life with a score of 56,577 and 60,757 for physical role and mental health respectively. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning and better outcome, while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.	Baseline and 5 weeks
Secondary	Perception of fear and trying to avoid pain in relation to physical and work activities measured by the Fear Avoidance Beliefs Questionnaire (FABQ).	The FABQ is a self-referential questionnaire consisting of 16 questions, each of which is scored from zero to six. Therefore, the total score is 96 points. Higher scores correspond to strong perceptions of fearing and avoiding pain indicating a worse outcome. Consequently, it consists of two subscales; the FABQ_physical (FABQ-P) composed of four questions and assessing the aforementioned parameters in relation to physical activities and the FABQ_work (FABQ-W), of seven questions on the same perceptions at work, with scores ranging between 0-24 (15 or greater is considered a high score) and 0-42 (34 or greater is considered a high score with a higher probability of not returning to work) respectively. The remaining five questions aim to distract the patient.	Baseline and 5 weeks
Secondary	Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS).	The PCS scale is a 13-item instrument derived from the definitions of catastrophizing analyzed in the literature and from items from the catastrophizing subscale of the Coping Strategies Questionnaire (CSQ). Participants will be asked to recall past painful experiences and rate each of 13 thoughts or feelings on a five-point scale, where zero (0) corresponds to not at all and four (4) to constantly/all the time. The total score is calculated from the sum of the individual 13 question scores and ranges from zero to 52. Higher scores indicate a greater degree of pain catastrophizing meaning a worse outcome. A total score of >30 represents a clinically significant level of pain catastrophization, while a score of zero corresponds to no pain catastrophizing thoughts.	Baseline and 5 weeks
Secondary	Subjective Evaluation of Pain measured by the Short Form McGill Pain Questionnaire (SFMPQ).	The SFMPQ questionnaire consists of 15 adjectives describing the sensation of pain -11 sensorial and four emotional. The patient self-rates them according to the level of intensity with the help of a four-point scale, where 0=No pain, 1=Mild, 2=Moderate and 3=Severe. The total score amounts to 45 points -33 for the sensorial subscale and 12 for the emotional subscale. The higher the total score on the SFMPQ, the more the pain experience for the patient increases indicating worse outcome.	Baseline and 5 weeks
Secondary	Subjective Evaluation of Pain measured by the Visual Analogue Scale (VAS)	The Visual Analogue Scale (VAS) measures pain intensity, asking the patient to rate their current level of pain by placing a mark on the line. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The following cut points have been recommended: no pain (0-0,4 cm), mild pain(0,5-4,4 cm), moderate pain (4,5-7,4 cm), and severe pain (7,5-10 cm). A higher score indicates greater pain intensity corresponding to a worse outcome.	Baseline and 5 weeks
Secondary	Subjective Evaluation of Pain measured by the Intensity Present Pain (IPP) Scale	The Intensity Present Pain consists of 5 points (0=No pain, 1=Mild, 2 =Annoying, 3=Painful, 4=Horrible, 5=Unbearable). The adjectives are ranked according to increasing intensity so each descriptor can be assigned a higher score. The higher point corresponds to worse outcome.	Baseline and 5 weeks