Effectiveness of Manual Therapy in Patients With Neck Pain. (NECKproject)

March 16, 2015 updated by: Rob Oostendorp, Radboud University Medical Center

Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.

Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.

Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables.

Study design: The study is a single blind randomized controlled trial.

Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks.

Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.

Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied.

Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed information about Manual Therapy according to the Utrecht School Manual Therapy (MTU)

MTU is based on assessing the patient's individual preference of functioning by documenting and interpreting their natural asymmetry in anatomical form, posture and movements. The normal asymmetry and variability of human form and movement function have been specified. Asymmetrical forms can be related to the asymmetrical movement function.

In addition to the general diagnostics, MTU is characterized by specific diagnostics. By means of this specific manual-therapeutic analysis the individual preference of functioning model of the patient is drawn up through analysis and interpretation of the individual asymmetry in form, posture and movement. Some explanations of the measurements and movements are: (preferred) hand folding; (preferred) arm folding; which eye is master eye; leg use in (preferred) kicking of a ball. The purpose here is to describe the optimal direction and position of movement axes for all joints according to this model.

When composing this model, firstly the individual characteristics (a number of preferred movements, a number of asymmetrical aspects of posture and form) are assessed. Documentation, notation and interpretation of these characteristics take place according to a protocol.

The objective of MTU is to optimize the positioning of movement axes in the joints. To achieve this, three-dimensional movements in the joints are executed repeatedly. To purpose fully position the movement axes the therapist should (repeatedly) perform passive joint movements with low velocity and high accuracy. In addition to examining the individual preference of movement, exploratory examination is carried out to recognize possible red flags and to determine the treatment indication.

Treatment is based on preferred movements found in the patient and the interpretation according to the protocol of these movements and not on the complaint of the patient. It is executed by applying passive articular movements in the spinal joints and the joints of the extremities. During this process physiological joint limitations are carefully observed; traction or high-velocity movements will not be applied, as may be the case in other forms of manual therapy.

The diagnostic examination of other forms of manual therapy focuses on joint function, stability, movement patterns, range of movement, and the severity of disorders. To diagnose the patients complaints, palpation of passive accessory and passive intervertebral movements are used. The results yield information as to tenderness (pain), restricted intersegmental motion (stiffness), and spasm (muscle tension).

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Dordrecht, Zuid-Holland, Netherlands, 3300 VB
        • NECKproject.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with at least two weeks of neck pain
  • Last episode starts at a maximum of one year ago
  • Age between 18 and 70 years
  • Patient is willing to undergo the treatment
  • Neck pain is mechanical and can be provocated by movements or postures of the neck
  • Neck pain is the main problem to treat
  • Neck pain may also give pain in the upper arm or cervicogenic headaches

Exclusion Criteria:

  • Appearance of "red flags"
  • Cervical surgery in the past
  • Pregnancy
  • Whiplash trauma
  • Health conditions with may disturb the treatment or makes it impossible to undergo the treatment.
  • Not enough understanding of the Dutch questionnaires
  • Undergoing treatments like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture, other types of exercise therapy during the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 Manual Therapy Utrecht

Manual Therapy Utrecht (MTU) During the first consultation the manual therapist enquires about the complaints of the patient. The manual therapist conducts a number of measurements according to protocol. During treatment preferred movements are executed by the manual therapist in the patient's joints. The treatment techniques used by the manual therapist are very gentle mobilizations, without high velocity thrust techniques and are in general painless. In Manual Therapy Utrecht (MTU) it is common to give advices and recommend exercises.

A treatment session lasts between 30 and 60 minutes (repeated after one or two weeks). The maximum number of sessions is six.

The manual therapist has a minimum of five years of working experience.
Other: Manual Therapy Utrecht
Manual Therapy (6 weeks).
Other Names:
  • joint mobilisation and manipulation
  • exercise therapy with instruction
ACTIVE_COMPARATOR: 2 Physical Therapy - Exercise Therapy

The physical therapist conducts a complaint related function examination. Treatment consist of active exercises, manual traction or stretching and massage. The aims of active exercises are improvement of strength, mobility and movement coordination. Specific mobilization techniques are not a part of physiotherapeutic treatment. Treatment sessions take place no more than twice a week with a maximum of nine sessions (approximately 30 minutes) with a minimum of twenty minutes on active exercise therapy combined with instruction.

To prevent overlap with MTU (experimental arm), physical therapists are selected who are not (also) trained as manual therapists or have started this education.

The physical therapist has at least five years of working experience.
Other: Physical Therapy
Physical Therapy (six weeks).
Other Names:
  • exercise therapy with instruction
  • massagetherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global Perceived Effect (GPE), Neck disability index (NDI-DV )
Time Frame: 0-3-7-13-26-52 weeks
0-3-7-13-26-52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS)for pain and SF36 (Quality of life). Multidimensional Health Locus of Control (MHLC), credibility/ expectancy, Fear Avoidance Beliefs Questionaire (FABQ-DLV)
Time Frame: 0-3-7-13-26-52 weeks
0-3-7-13-26-52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: Rob Oostendorp, Prof. dr., UMC St Radboud, IQ healthcare, Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL21128.091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neck Pain

Clinical Trials on Manual Therapy Utrecht

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe