Clinical trial NCT00713843: Effectiveness of Manual Therapy in Patients With Neck Pain.
Official title: Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Manuel Therapy Utrecht
Physiotherapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Global Perceived Effect (GPE), Neck disability index (NDI-DV )
timeFrame: 0-3-7-13-26-52 weeks
Secondary outcomes:
measure: 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)
timeFrame: 0-3-7-13-26-52 weeks
Other outcomes:
Locations:
city: Dordrecht
country: Netherlands
facility: NECKproject.nl
state: Zuid-Holland
Study officials:
affiliation: UMC St Radboud, IQ healthcare, Nijmegen
name: Rob Oostendorp, Prof. dr.
role: STUDY_CHAIR
References:
citation: Groeneweg R, Haanstra T, Bolman CAW, Oostendorp RAB, van Tulder MW, Ostelo RWJG. Treatment success in neck pain: The added predictive value of psychosocial variables in addition to clinical variables. Scand J Pain. 2017 Jan;14:44-52. doi: 10.1016/j.sjpain.2016.10.003. Epub 2016 Nov 2.
citation: Groeneweg R, van Assen L, Kropman H, Leopold H, Mulder J, Smits-Engelsman BCM, Ostelo RWJG, Oostendorp RAB, van Tulder MW. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial. Chiropr Man Therap. 2017 Apr 28;25:12. doi: 10.1186/s12998-017-0141-3. eCollection 2017.
citation: van Dongen JM, Groeneweg R, Rubinstein SM, Bosmans JE, Oostendorp RA, Ostelo RW, van Tulder MW. Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial. Eur Spine J. 2016 Jul;25(7):2087-96. doi: 10.1007/s00586-016-4526-0. Epub 2016 Mar 21.
citation: Groeneweg R, Kropman H, Leopold H, van Assen L, Mulder J, van Tulder MW, Oostendorp RA. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT). BMC Musculoskelet Disord. 2010 Jan 24;11:14. doi: 10.1186/1471-2474-11-14.