Clinical trial NCT04268667: Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain
Official title: A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: disability evaluation
musculoskeletal manipulations
neck pain
spinal manipulation
Lead sponsor: Clínica Ciudad de Almería
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.


Eligibility criteria: Inclusion Criteria:

* Symptom persistence for more than 12 weeks.
* Age from 18 to 55 years.
* Localized pain in the cervical spine.
* Symptoms are caused by cervical movement or sustained postures.

Exclusion Criteria:

* Stage acute of symptoms.
* Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).
* Patients with previous neck trauma or cervical spine surgery.
* Patients diagnosed with cervical radiculopathy.
* Patients diagnosed with fibromyalgia.
* Have been treated with manual therapy in the last 3 months.
* Receiving other treatment during the course of the study.

Primary outcomes:
measure: Change in neck pain at rest: Numeric Pain Rating Scale (0-10)
timeFrame: Baseline and 7 days post-treatment
measure: Change in neck disability: Neck Disability Index (0-50)
timeFrame: Baseline and 7 days post-treatment
Secondary outcomes:
measure: Change in flexion movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
measure: Change in extension movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
measure: Change in rigth lateral flexion movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
measure: Change in left lateral flexion movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
measure: Change in right rotation movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
measure: Change in left rotation movement: Cervical Range of Motion device
timeFrame: Baseline and 7 days post-treatment
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Clínica Ciudad de Almería
Study officials:
affiliation: Clinica Ciudad de Almería
name: Raúl Romero del Rey, Mr
role: PRINCIPAL_INVESTIGATOR
References: