Clinical trial NCT05004467: Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain
Official title: Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain: a Machine Learning Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder of Spine
Placebo Effect
Disability Physical
Keywords: Therapeutic Effect
Manual Therapy
Physiotherapy
Neck Pain
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 60 years.
* Neck pain with/without pain in upper limb/s.
* NDI ≥ 10
* Acceptance of the study and completion of the informed consent form.

Exclusion Criteria:

* Presenting physician-diagnosed "red flag" of non-musculoskeletal origin.
* Having had a Whiplash in the last 2 years.
* Use of cervical collar in the last year.
* Evidence of CNS involvement.
* Vestibular Disorders
* Inflammatory joint disease
* Spinal cord pathology
* Bone disease or marked osteoporosis
* Intervertebral disc protrusion
* Subjects who have received physiotherapeutic treatment of the cervical or thoracic region three months previously.
* Fractures, sprain or dislocation of the neck, occurred in a period of less than two months.
* Previous shoulder, upper limb and cervical spine surgery, which occurred in the twelve months prior to the investigation.
* Pregnancy
* Illness
* Voluntary abandonment

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from base line and immediately after the intervention
measure: Pressure Pain Threshold
timeFrame: Change from base line and immediately after the intervention
measure: Cervical Range of Movement (CROM)
timeFrame: Change from base line and immediately after the intervention
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Change from base line and immediately after the intervention
measure: STAI (State-Trait Anxiety)
timeFrame: Change from base line and immediately after the intervention
measure: Beck II (Depression)
timeFrame: Change from base line and immediately after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández Carnero, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Europea de Madrid
name: Eleuterio A Sánchez Romero, PhD
role: PRINCIPAL_INVESTIGATOR
References: