Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain

Neck Pain Clinical Trial

Official title:

A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268667
• Other study ID #: spinal manipulation
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: Clínica Ciudad de Almería
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Spinal manipulation
Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.

Locations

Country	Name	City	State
Spain	Clínica Ciudad de Almería	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Ciudad de Almería

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neck pain at rest: Numeric Pain Rating Scale (0-10)	Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).	Baseline and 7 days post-treatment
Primary	Change in neck disability: Neck Disability Index (0-50)	Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.	Baseline and 7 days post-treatment
Secondary	Change in flexion movement: Cervical Range of Motion device	Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment
Secondary	Change in extension movement: Cervical Range of Motion device	Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment
Secondary	Change in rigth lateral flexion movement: Cervical Range of Motion device	Range of cervical motion in right lateral flexion. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment
Secondary	Change in left lateral flexion movement: Cervical Range of Motion device	Range of cervical motion in left lateral flexion. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment
Secondary	Change in right rotation movement: Cervical Range of Motion device	Range of cervical motion in right rotation. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment
Secondary	Change in left rotation movement: Cervical Range of Motion device	Range of cervical motion in left rotation. Measured with a Cervical Range of Motion (CROM) device	Baseline and 7 days post-treatment