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

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

Interventions

OTHER

Clinical reasoning based physiotherapy + cervical movement control training

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

OTHER

Clinical reasoning based physiotherapy + orofacial movement control training

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

OTHER

Clinical reasoning based physiotherapy + standard exercises

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.

Sponsors & Collaborators

• Medizinische Gesellschaft für Myofasziale Schmerzen e.V.

  collaborator UNKNOWN

• Therapiecentrum Voxtrup - Praxis für Physiotherapie

  collaborator UNKNOWN

• Facharztzentrum für Orthopädie, Unfallchirurgie und Rehabilitation des Bewegungssystems

  collaborator UNKNOWN

• Hochschule Osnabruck

  lead OTHER

Principal Investigators

• Susan Armijo-Olivo, PhD · Hochschule Osnabruck

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-25

Primary Completion

2024-05-30

Completion

2024-12-31

Countries

• Germany

Study Locations