Neck PainFMvsCNPNCT05870371
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
A study testing Feldenkrais Awareness Through Movement technique, Acupuncture and Stretching in people with Neck Pain, run by University of West Attica at 2 sites in Greece.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Feldenkrais Awareness Through Movement technique, Acupuncture and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- 26 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Aretaio Hospital
Athens, Attica, 11528
Laboratory of Musculoskeletal Physiotherapy, University of West Attica
Athens, Attica, 12243
About this study
Official title: The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Neck Pain
- Being tested
- Feldenkrais Awareness Through Movement technique, Acupuncture, Stretching
- Keywords
- Feldenkrais, Awareness Through Movement, Functionality, Non specific, Chronic Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais Awareness Through Movement techniqueBehavioural
10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
AcupunctureBehavioural
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.
StretchingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Feldenkrais Awareness Through Movement | Experimental | Application of the Feldenkrais Awareness Through Movement technique in group sessions. Receives: Behavioral: Feldenkrais Awareness Through Movement technique |
| Acupuncture and Stretching | Active comparator | Acupuncture protocol in combination with stretching exercises. Receives: Behavioral: Acupuncture; Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
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).
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Secondary outcomes (15)
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Pain Intensity Measured by the Visual Analogue Scale
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Present Pain Intesity Measured by the Present Pain Intensity Index.
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Neck Disability Measured by the Neck Disability Index
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).
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
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).
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Kinesiophobia Measured by the Tampa Scale Kinesiophobia
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Quality of Life Measured by the Short Form 12 Health Survey.
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.
Measured: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Global Perceived Effect Measured by the Global Perceived Effect Scale
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.
Measured: Participants were assessed after the completion of the interventions (five weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start26 Sep 2022
- Primary completion16 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Skordis Charalampos, University of West Attica
- Investigators
- CHARALAMPOS SKORDIS, Principal investigator, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870371
- Sponsor's protocol ID
- 103276/18-12-2020
- Other IDs
- Research and Ethics Committee
- Acronym
- FMvsCNP
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2022
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05870371
- Acronym / sponsor ID
- FMvsCNP / 103276/18-12-2020
- Conditions
- Neck Pain
- Keywords
- Feldenkrais, Awareness Through Movement, Functionality, Non specific, Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feldenkrais Awareness Through Movement | Experimental | Behavioral: Feldenkrais Awareness Through Movement techniqueApplication of the Feldenkrais Awareness Through Movement technique in group sessions. |
| Acupuncture and Stretching | Active comparator | Behavioral: Acupuncture, Behavioral: StretchingAcupuncture protocol in combination with stretching exercises. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feldenkrais Awareness Through Movement technique10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique | Behavioural | Feldenkrais Awareness Through Movement |
| Acupuncture10 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. | Behavioural | Acupuncture and Stretching |
| Stretching10 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. | Behavioural | Acupuncture and Stretching |
Primary outcome
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Time frame: 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).
15 secondary outcomes
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Pain Intensity Measured by the Visual Analogue Scale
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Present Pain Intesity Measured by the Present Pain Intensity Index.
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Neck Disability Measured by the Neck Disability Index
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Kinesiophobia Measured by the Tampa Scale Kinesiophobia
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Quality of Life Measured by the Short Form 12 Health Survey.
Time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Global Perceived Effect Measured by the Global Perceived Effect Scale
Time frame: Participants were assessed after the completion of the interventions (five weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHARALAMPOS SKORDIS principal investigator
University of West Attica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feldenkrais Awareness Through Movement technique, Acupuncture and Stretching in people with Neck Pain, run by University of West Attica at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah. (time frame: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.