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OpenTrials
Completed

NCT Number: NCT04268667

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Ciudad de Almería

Almería, 04008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal Manipulation

Other

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 outcomes

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

    Time frame: Baseline and 7 days post-treatment

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

  2. Change in neck disability: Neck Disability Index (0-50)

    Time frame: Baseline and 7 days post-treatment

    Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.

Secondary outcomes

  1. Change in flexion movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

  2. Change in extension movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

  3. Change in rigth lateral flexion movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

  4. Change in left lateral flexion movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

  5. Change in right rotation movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

  6. Change in left rotation movement: Cervical Range of Motion device

    Time frame: Baseline and 7 days post-treatment

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

Sponsors and collaborators

Lead sponsor

Clínica Ciudad de Almería

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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