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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stichting Garantiefonds Spaarneland, The Netherlands
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00713843
First received: June 30, 2008
Last updated: February 11, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention
Neck Pain
Other: Manual Therapy Utrecht
Other: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Global Perceived Effect (GPE), Neck disability index (NDI-DV ) [ Time Frame: 0-3-7-13-26-52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: September 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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 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

The physical therapist conducts a complaint related function examination. Treatment consist of active exercises, manual traction or stretching and massage. The aims of 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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713843

Locations
Netherlands
NECKproject.nl
Dordrecht, Zuid-Holland, Netherlands, 3300 VB
Sponsors and Collaborators
Radboud University
Stichting Garantiefonds Spaarneland, The Netherlands
Investigators
Study Chair: Rob Oostendorp, Prof. dr. UMC St Radboud, IQ healthcare, Nijmegen
  More Information

Additional Information:
No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R. Groeneweg, UMC St Radboud department IQ healthcare
ClinicalTrials.gov Identifier: NCT00713843     History of Changes
Other Study ID Numbers: NL21128.091, NTR1208
Study First Received: June 30, 2008
Last Updated: February 11, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Neck Pain
Manuel Therapy
Physiotherapy

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014