Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain

NCT05004467 | Completed

• 1 other identifier: Clinical predictive effects
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder of Spine; Placebo Effect; Disability Physical

Keywords

Therapeutic Effect; Manual Therapy; Physiotherapy; Neck Pain

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS)

  To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.

  Change from base line and immediately after the intervention

• Pressure Pain Threshold

  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.

  Change from base line and immediately after the intervention

• Cervical Range of Movement (CROM)

  Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90º (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies.

  Change from base line and immediately after the intervention

Secondary Outcomes (3)

• Neck Disability Index

  Change from base line and immediately after the intervention

• STAI (State-Trait Anxiety)

  Change from base line and immediately after the intervention

• Beck II (Depression)

  Change from base line and immediately after the intervention

Study Arms (2)

Mobilization with movement technique

EXPERIMENTAL

The therapist applies supported pressure on right and left side and articular planes. Meanwhile, the patient executes active movements and the therapist is trying to find the specifies cervical joint to get partial or total painful relief or movements with restrictions. If the therapist couldn´t relief or remove pain or restriction with the pressure permorfem, he will readjust pressure and slide in differents planes of motion. It is necessary achieve that aim. After that, the patient stay in sit down raised position on a stool, with his back in contact with the wall. Hip, knee and ankle of the patient suppor a certain position: 90º of flexion which will be checked with a conventional goniometer. His hands are on the thighs. The treatment lasts 5 minutes.

Other: Mobilization With Movement Technique

Placebo technique

SHAM COMPARATOR

Placebo manual technique is performed similar to experimental group technique but no slides are performed. The therapist simply embraces cervical region with boths hands, avoiding any pressure or any painfully caoture.

Other: Mobilization With Movement Technique

Interventions

Mobilization With Movement Technique OTHER

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.

Mobilization with movement technique; Placebo technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrid

Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

• Eleuterio A Sánchez Romero, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the subjects assigned to the groups nor the researchers who measured the variables knew which group they belonged to. Patients will be randomly assigned through GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 2 study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: August 2, 2021
• Primary Completion: February 10, 2022
• Study Completion: March 18, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

ES (1)