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

NCT05870371 | Completed Results

• 2 other identifiers: 103276/18-12-2020Research and Ethics Committee
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Keywords

Feldenkrais; Awareness Through Movement; Functionality; Non specific; Chronic Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  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 )

  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

  Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.

• Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc

  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

  Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.

Study Arms (2)

Feldenkrais Awareness Through Movement

EXPERIMENTAL

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

Behavioral: Feldenkrais Awareness Through Movement technique

Acupuncture and Stretching

ACTIVE COMPARATOR

Acupuncture protocol in combination with stretching exercises.

Behavioral: Acupuncture; Behavioral: Stretching

Interventions

Feldenkrais Awareness Through Movement technique 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

Feldenkrais Awareness Through Movement

Acupuncture 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.

Acupuncture and Stretching

Stretching 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.

Acupuncture and Stretching

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (2)

Aretaio Hospital

Athens, Attica, 11528, Greece

Location

Laboratory of Musculoskeletal Physiotherapy, University of West Attica

Athens, Attica, 12243, Greece

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

There are several limitations. Firstly, the numerous exclusion criteria applied on the patients could affect the generalization of the results. Secondly, there is potential bias due to the lack of patients' and physiotherapists' blinding. Thirdly, the long-term efficacy of FM could not be evaluated because of the absence of a follow-up period. Another limitation is represented by the heterogeneity in the severity of the patients' symptoms.

Results Point of Contact

• Title: Dr. George Georgoudis
• Organization: Musculoskeletal Research Laboratory (MRL) of Physiotherapy Department University of West Attica, Athens, Greece

physiolab@uniwa.gr

+30-210-5387487

Study Officials

• CHARALAMPOS SKORDIS

  University of West Attica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: May 23, 2023
• Study Start: September 26, 2022
• Primary Completion: December 16, 2022
• Study Completion: June 30, 2023
• Last Updated: April 23, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-04

Locations

GR (2)