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

Not Applicable

Completed

Conditions: Neck Pain

Registration Number: NCT05870371

Lead Sponsor: University of West Attica

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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The selected algometer (Commander Algometer, JTECH Medical, Midvale, Utah) was used to measure pain sensitivity through the application of pressure. This device can identify the pressure eliciting a pressure-pain threshold. The pain sensitivity recording was performed at specific points with 3 measurements taken at each. The first measurement was considered tentative and was rejected and the final value was the result from the average of the two remaining measurements. The sites that were selected for the pain pressure threshold measurements were the Mastoid Process, the Bladder 10 (BL 10), the C5-C6 Zygapophyseal Joint, the Upper Trapezius Muscle, the Levator Scapula Muscle, the Deltoid Muscle and the Tibialis Anterior Muscle, bilaterally (left and right).

Secondary Outcome Measures

Name	Time	Method
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The 3D Inertial Motion Moover® Sensor of the company SENSOR medica Technology in Motion (Guidonia Montecelio, Roma, Italia) was used to record cervical range of motion by evaluating cervical spine motion, acceleration and rotation. The sensor was positioned in the center of the patients' forehead on the frontal bone at the level of the glabella and was fastened around the head with the assistance of a strap. Patients were seated with their back straight and their chin parallel to the floor while looking at a target corresponding to their field of view. They were then asked to perform 3 cervical movements (left-right rotation, left-right lateral flexion, flexion-extension) for 3 times each with a pause at each final position. Throughout the process, the examiner's assistant stabilized the patient's trunk and shoulders with their hands and encouraged their constant continuing of each movement.
Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	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.
Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Forced Vital Capacity (FVC). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was blocked with the use of a clip. Patients inhaled slowly and deeply through the nozzle. Once their lungs were fully filled up with air, they were encouraged to exhale explosively for a minimum duration of 6 seconds.
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Short Form McGill Pain Questionnaire (SFMPQ) consists of 15 descriptors of pain sensation -11 sensory and 4 affective. The patient rates each description on a four-point intensity scale (0 - no pain, 1 - mild pain, 2 - moderate pain, and 3 - severe pain). The total score ranges from 0 to 45 points, the sensory subscale score from 0 to 33 points and the affective subscale score from 0 to 12 points. The higher the total score on the SFMPQ, the more the pain experience for the patient increases, indicating worse outcome. The Visual Analogue Scale (VAS) and the Present Pain Intensity (PPI) scale are included in the SFMPQ.
Pain Intensity Measured by the Visual Analogue Scale	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Visual Analogue Scale (VAS) measures pain intensity, asking the patient to rate their current or past 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 higher pain intensity corresponding to a worse outcome.
Present Pain Intesity Measured by the Present Pain Intensity Index.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Present Pain Intensity (PPI) is a six-point rating scale, which ranges from 0 to 5 (0=No pain, 1=Mild, 2 =Annoying, 3=Painful, 4=Horrible, 5=Unbearable). The descriptions are ranked according to increasing intensity so each of them can reflect a higher score. The higher point corresponds to worse outcome.
Neck Disability Measured by the Neck Disability Index	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	Neck Disability Index (NDI) consists of ten items, each of them 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 is five which refers to the worst pain and maximum limitation. Therefore, it is 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%) to moderate disability, 25-34 (50%-68%) to severe and 35-50 (70%-100%) to absolute disability (higher scores mean a worse outcome).
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Hospital Anxiety and Depression Scale (HADS) 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 depression/anxiety, and 11-21 to abnormal depression/anxiety (higher scores mean a worse outcome).
Kinesiophobia Measured by the Tampa Scale Kinesiophobia	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Tampa Scale Kinesiophobia (TSK) is 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.
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Fear Avoidance Beliefs Questionnaire (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 fear and avoiding pain, indicating a worse outcome. 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), comprised 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.
Quality of Life Measured by the Short Form 12 Health Survey.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Short Form (SF)-12 Health Survey is the short form of the SF-36 which contains 12 out of 36 questions. It assesses the parameters physical functioning (PF), physical and emotional role (role physical/RP, role emotional/RE) and mental health (MH), using two items. The parameters bodily pain (BP), general health (GH), social functioning (SF) and vitality (VT) are represented by a single item. All 12 items are used to measure the physical and mental component summary scores (PCS-12 and MCS-12). Scores in subscales range from 0 to 100 and higher scores are indicative of better mental and physical health status and better outcome. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	The Pain Catastrophizing Scale (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 0 to 52. The Rumination subscale score ranges from 0 to 16 points, the Magnification subscale score from 0 to 12 points and the Helplessness subscale score from 0 to 24 points. 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.
Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Vital Capacity (VC). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was blocked with the use of a clip. Patients inhaled slowly and deeply through the nozzle. Once their lungs were fully filled up with air, they were encouraged to exhale slowly and extensively until the lungs were fully emptied.
Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc	Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.	For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Maximum Voluntary Ventilation (MVV). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was 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.
Global Perceived Effect Measured by the Global Perceived Effect Scale	Participants were assessed after the completion of the interventions (five weeks).	The Global Perceived Effect (GPE) cale was used to assess the perceived change of the subject's health condition. It asks the patient to rate how much their condition has worsened or improved relatively to another predetermined point in time (before the treatments). It is a numerical scale which consists of only one question with 5 possible answers. Values range between 1-5 with the higher score indicating worse outcome.

Trial Locations

Locations (2): Aretaio Hospital
🇬🇷
Athens, Attica, Greece
Laboratory of Musculoskeletal Physiotherapy, University of West Attica
🇬🇷
Athens, Attica, Greece
Aretaio Hospital
🇬🇷Athens, Attica, Greece