Manual Therapy and Movement Control Exercises for Chronic Neck Pain. A Pilot Randomized Controlled Trial

NCT06189612 | Unknown

• 1 other identifier: HSOS/2023/9/15
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic neck pain is a common and highly prevalent clinical entity among the population. It causes a high economic and financial burden. Commonly people with neck pain present temporomandibular disorders (TMD). These conditions are closely correlated with each other. Several studies have shown that patients with neck pain do have abnormalities in motor control, endurance capacities, and strength of the cervical and orofacial area. Several treatment modalities are available for neck pain that can be divided into pharmaceutical and non-pharmaceutical approaches. Among the non-pharmaceutical interventions, physiotherapy, manual therapy and exercises are of interest. The effect of treatment modalities is heterogeneous. Passive modalities often lack positive long-term outcomes. Therefore, our trial aims to measure the effects of a combined treatment, consisting in manual therapy and a movement control training for the neck region or for the temporomandibular region, respectively. The implementation of the temporomandibular movement control training is based on the assumption that there might be crossover effects between both regions, i.e., convergence of cervical and trigeminal sensory afferents between these two regions. We designed a parallel randomized controlled trial (RCT) with three intervention arms and a blinded assessor for outcomes that are clinician performed. This study is a pilot trial, so each group is expected to consist of 15 subjects. Both female and male patients between the ages of 18 and 65 will be included. Participants must suffer from idiopathic chronic neck pain (at least 3 months) and may also have symptomatic TMD disorders. The Primary Outcome will be neck pain disability measured by the Neck Disability Index (NDI). Secondary Outcomes will be Diagnostic Criteria (DC)/TMD (Axis I and Axis II), range of motion (CROM, FRT), CVA, PPT, CCFT, and both cervical and orofacial test batteries to assess motor control in each region. Patients are randomly assigned to one of the three intervention groups using a computer-generated sequence which is concealed. The three groups are: 1) clinical reasoning (CR) based physical therapy + cervical motor control training, 2) CR based physical therapy + orofacial motor control training, 3) CR based physical therapy + general coordination and strengthening exercises for the jaw and neck region. Prior to the start of treatment, participants will undergo an eligibility assessment. If the participant meet the inclusion criteria, the baseline assessment is conducted, and the treatment is planned following the prescription for physiotherapy in Germany. Treatment will comprise six 30-minute treatment sessions, which take place once a week over a period of 6 weeks. Upon completion of the six treatment sessions, the final examination is conducted, which includes the same assessments as the initial examination.

Conditions

Neck Pain; Temporomandibular Disorder

Keywords

Exercises; Motor control

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  This is a 10-item self-report questionnaire designed to assess the extent to which neck pain interferes with activities daily living. The Neck Disability Index is a validated, reliable and responsive tool. The score ranges from 0 and 50 points, the achieved value is divided by the maximum score of 50 and multiplied by 100. This is how the score of the NDI is calculated. A higher value equals higher disability.

  baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)

Secondary Outcomes (7)

• Diagnostic criteria for temporomandibular disorders DC/TMD (Axis I and Axis II)

  baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)

• Craniovertebral angle

  Time Frame: baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)

• Pressure Pain Threshold

  baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)

• Craniocervical flexion test

  baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)

• Cervical test battery to assess movement control in the cervical region

  baseline, final evaluation ( (6 treatments (6-8 weeks) after the baseline measurement)

Study Arms (3)

Group1: Clinical reasoning-based physiotherapy + cervical movement control training

EXPERIMENTAL

Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients the abnormal (positive) tests of the test battery for assessing motor control of the cervical region as a self-exercise for home use. To do this, patients are also given access via a quick response (QR) code to a website where they can find videos and instructions for the exact exercises that are in their home program.

Other: Clinical reasoning based physiotherapy + cervical movement control training

Group 2: Clinical reasoning-based physiotherapy + orofacial movement control training

EXPERIMENTAL

Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients the abnormal (positive) tests of the test battery for assessing motor control of the orofacial region as a self-exercise for home use. To do this, patients are also given access via a QR code to a website where they can find videos and instructions for the exact exercises that are in their home program.

Other: Clinical reasoning based physiotherapy + orofacial movement control training

Group 3: Clinical reasoning-based physiotherapy + standard exercises

ACTIVE COMPARATOR

Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients general coordination- and strength exercises for the jaw and the cervical region as a self-exercise for home use. To do this, patients are also given access via a QR code to a website where they can find videos and instructions for the exact exercises that are in their home program.

Other: Clinical reasoning based physiotherapy + standard exercises

Interventions

Clinical reasoning based physiotherapy + cervical movement control training OTHER

An individualized cervical motor control training based on the positive tests of the test battery introduced by Patroncini et al. (2014).

Group1: Clinical reasoning-based physiotherapy + cervical movement control training

Clinical reasoning based physiotherapy + orofacial movement control training OTHER

An individualized orofacial motor control training based on the positive tests of the test battery introduced by von Piekartz et al. (2017).

Group 2: Clinical reasoning-based physiotherapy + orofacial movement control training

Clinical reasoning based physiotherapy + standard exercises OTHER

A generalized training regimen based on exercises which are taught in physiotherapy training for the neck and scapula region preventing the overlap with exercises of the test batteries.

Group 3: Clinical reasoning-based physiotherapy + standard exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 - 65 years of age
• being diagnosed with idiopathic chronic neck pain (\>= 3 month)
• scoring minimum \>= 15 in the NDI
• linguistic (german) and cognitive ability to fully understand the questionnaires and exercise instructions.

You may not qualify if:

• presence of neurological symptoms of the upper limb
• presence of elapsed fractures or surgeries in the past half year in the head, jaw or cervical region
• medical interventions in these regions
• systemic inflammatory conditions requiring systemic-acting drugs
• Central Sensitization Index (CSI) score \> 40 points

Sponsors & Collaborators

• Hochschule Osnabruck: lead
• Medizinische Gesellschaft für Myofasziale Schmerzen e.V.: collaborator
• Therapiecentrum Voxtrup - Praxis für Physiotherapie: collaborator
• Facharztzentrum für Orthopädie, Unfallchirurgie und Rehabilitation des Bewegungssystems: collaborator

Study Sites (1)

Hochschule Osnabrück

Osnabrück, Lower Saxony, 49076, Germany

RECRUITING

Related Publications (3)

• Patroncini M, Hannig S, Meichtry A, Luomajoki H. Reliability of movement control tests on the cervical spine. BMC Musculoskelet Disord. 2014 Nov 29;15:402. doi: 10.1186/1471-2474-15-402.

  PMID: 25432070 BACKGROUND

• von Piekartz H, Stotz E, Both A, Bahn G, Armijo-Olivo S, Ballenberger N. Psychometric evaluation of a motor control test battery of the craniofacial region. J Oral Rehabil. 2017 Dec;44(12):964-973. doi: 10.1111/joor.12574. Epub 2017 Sep 30.

  PMID: 28892191 BACKGROUND

• Franki I, Van den Broeck C, De Cat J, Molenaers G, Vanderstraeten G, Desloovere K. A study of whether video scoring is a reliable option for blinded scoring of the Gross Motor Function Measure-88. Clin Rehabil. 2015 Aug;29(8):809-15. doi: 10.1177/0269215514558642. Epub 2014 Nov 21.

  PMID: 25416132 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Temporomandibular Joint Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Susan Armijo-Olivo, PhD

  Hochschule Osnabruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry von Piekartz, PhD

CONTACT

+49(0)541 969-3526; h.von-piekartz@hs-osnabrueck.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessing clinician will be blinded to group allocation. Participants will be unaware of the hypothesis of this study to decrease performance biases.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups (msk + cervical motor control training, msk + orofacial motor control training, msk + standard exercises) will receive the protocol at the same time period.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: May 25, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2023-12

Locations

DE (1)