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

NCT ID: NCT05870371

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2023-06-30

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Feldenkrais Awareness Through Movement

Application of the Feldenkrais Awareness Through Movement technique in group sessions.

Group Type: EXPERIMENTAL

Feldenkrais Awareness Through Movement technique

Intervention Type: BEHAVIORAL

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 and Stretching

Acupuncture protocol in combination with stretching exercises.

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of West Attica

OTHER

Sponsor Role: lead

Responsible Party

Skordis Charalampos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CHARALAMPOS SKORDIS

Role: PRINCIPAL_INVESTIGATOR

University of West Attica

Locations

Aretaio Hospital

Athens, Attica, Greece

Laboratory of Musculoskeletal Physiotherapy, University of West Attica

Athens, Attica, Greece

Countries

Greece

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Research and Ethics Committee

Identifier Type: REGISTRY

Identifier Source: secondary_id

103276/18-12-2020

Identifier Type: -

Identifier Source: org_study_id