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

Primary Purpose

Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Spinal manipulation

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clínica Ciudad de Almería

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upper cervical spine manipulation group

Cervicothoracic spine manipulations group

Arm Description

Spinal thrust joint manipulation on the atlantoaxial joint

Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1).

Outcomes

Primary Outcome Measures

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).

Change in neck pain in flexion: Numeric Pain Rating Scale (0-10)

Pain in the cervical flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Change in neck pain in extension: Numeric Pain Rating Scale (0-10)

Pain in the cervical extension movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Change in neck pain in right lateral flexion: Numeric Pain Rating Scale (0-10)

Pain in the cervical right lateral flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Change in neck pain in left lateral flexion: Numeric Pain Rating Scale (0-10)

Pain in the cervical left lateral flexion movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Change in neck pain in right rotation: Numeric Pain Rating Scale (0-10)

Pain in the cervical right rotation movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Change in neck pain in left rotation: Numeric Pain Rating Scale (0-10)

Pain in the cervical left rotation movement. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

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.

Change in flexion movement: Cervical Range of Motion device

Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device

Change in extension movement: Cervical Range of Motion device

Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device

Change in right 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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04268667

First Posted

February 11, 2020

Last Updated

June 8, 2020

Sponsor

Clínica Ciudad de Almería

1. Study Identification

Unique Protocol Identification Number

NCT04268667

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

February 17, 2020 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clínica Ciudad de Almería

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upper cervical spine manipulation group

Arm Type

Experimental

Arm Description

Spinal thrust joint manipulation on the atlantoaxial joint

Arm Title

Cervicothoracic spine manipulations group

Arm Type

Active Comparator

Arm Description

Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1).

Intervention Type

Other

Intervention Name(s)

Spinal manipulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in neck pain at rest: Numeric Pain Rating Scale (0-10)

Description

Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).

Time Frame