Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain
Condition: Orthopedic Disorder of Spine; Placebo Effect; Disability Physical
MeSH terms: Musculoskeletal Diseases; Spinal Diseases; Neck Pain
Study type: Interventional

Summary: 
      The aim of the study is the measurement and comparison of two manual therapy techniques, the
      Mulligan´s mobilization with movement technique, and de placebo technique, both applicated in
      patients with subacute neck pain.
    

Detailed description: 
      Study design:

      A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical
      trial was conducted, where both the study subject and the researcher performing the
      measurements do not know which treatment group they belong to. Patients were randomly
      assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 2
      study groups: experimental group and placebo group.

      Participants:

      The sample was composed of 42 sub-acute and inespecific neck pain patients residing in the
      Community of Madrid, all of whom were recruited personally for the study. Experimental group
      includes 21 subjects who received a manual theraphy technique named Mobilization with
      Movement (MWM) for a total of four sessions, distributed in two sessions per week. . Placebo
      group includes 21 subjects who received a placebo technique the same times.

      Measurement instruments:

      The primary outcomes of interest were true and total cervical ROM, Pain Pressure Threshold
      (PPT), pain intensity, Neck Disabilty Index, anxiety scale and depression scale. Secondary
      outcomes were pain and/or neck stiffnes for musculosketletal causes.

      Goniometry

      This is the measurement of angles on the arc of motion of a joint. Goniometry is a
      quantitative variable and numerical and unit of measurement is in degrees.

      Measurement of cervical motion was performed with the device CROM (Cervical Range Of Motion)
      due to the extensive evidence as to its reliability. This device has two gravity goniometers,
      indicating the mobility in the sagittal and frontal planes (measurement of the
      flexion-extension and lateral inclination, respectively). For the transverse plane, the
      goniometer has a compass, a magnet with magnetic resting on the shoulders to measure neck
      rotation.

      Algometry

      Consists in measuring the pain threshold pressure, by stimulating the receptors of pressure.
      This threshold is defined as the minimal amount of pressure that produces pain.

      Algometry is a quantitative variable and gives numerical values in Kilograms/cm2.

      To study algometry has relied on a digital algometer Wagner Force One Digital Force Gage FDX
      model 100 with an 1cm2 head. This device, used with a gradually application of manual force
      and consistently, and prior familiarity with the user, has a high fiability.

        -  Intensity of pain measured by visual analogue scale (VAS) just before and immediately
           after treatment.

        -  Neck disability index: Scale completed by the patient before tratment

        -  BECK: Scale completed by the patient before tratment.

        -  STAI: Scale completed by the patient before tratment.

        -  Mobilization with movement technique: Technique therapy applied to the experimental
           group.

      Procedural protocol:

      Measures were collected before and after intervention, stablishing the hypotesys about
      reasons and inmediate effects in relation with the tecnique applied.

      No follows-up will be done to the patients. It is supposed like a bounding factor in that
      study.

      - Goniometric measurements procedure: The patient position for goniometric measurement is
      similar to the physiotherapist intervention, described previously.

      The patient actively and in all range of motion , perform flexion, extension, bilateral
      lateral flexion and bilateral rotation movements. And then, the therapist will gather the
      parameters at the end of every movement.

      All goniometric measures will be reported three times and the average of three measurements
      will be calculated.

      Goniometric informacion is collected just before the therapeutic intervention and five
      minutes later.

      - Pressure algometer measurements procedure: The patient supine with algometer perpendicular
      to the exactly point for evaluation, and the pressure is increasing slowly and linearly. The
      intervention speed applied will be 1kg/cm2/second until the patient feels pain. Just in that
      moment, the researcher stops pressure.

      Hereby a target response is favored due to fact that patient has more reaction time when he
      starts to feel pain. In that moment, the researcher interrumps exercised pressure with the
      algometer.

      In every anatomical reference, three measures will be performed consecutively in intervals of
      30 seconds for measurement to generate an average, neccesary for statical analysis.

      Pain pressure threshold measure is performed just before therapeutic intervention and 5
      minutes later.

      - Anatomical References to study: Bilateral measurement of superior cervical region in spine
      C2: To plan a horizontal line between spine C2 to both sides, separated 1 cm to the spine
      point.

      Bilateral measurement of superior cervical region in spine C7: To plan a horizontal line
      between spine C7 to both sides, separated 1cm to the spine point.

      Superior Trapezius measurement: Horizontal line between acromion to spine C7 Lateral
      Epycondile measurement: lateral prominence of distal humeral epiphysis with the superior
      extremity supported on the table.

      The algometer technique is performed just before therapeutic intervention and 5 minutes
      later.
    

Intervention name(s): Mobilization With Movement Technique
Intervention type(s): Other
Intervention description(s): The researcher explains cervical movements to the patient to be done while the technique is performed. This movements will be the painful and limited movements detected in goniometric intervention before the treatment and movements done actively and in all range of motion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study design:
A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial will be carried out in which both the study subject and the researcher who made the measurements do not know which treatment group they belong to.
Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were personally recruited for the study. All of them will have two different manual therapy techniques (Mulligan and placebo) for acute or subactute neck pain. All patients will read the information sheet that explains what the study will consist of, as well as the informed consent form, which they will voluntarily sign before the intervention.
Each group will be given a different sentence: one group will attempt to influence with a positive expectation, another with a neutral expectation, and yet another will attempt to influence with a negative expectation.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic Effect; Manual Therapy; Physiotherapy; Neck Pain