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

NCT04268667 | Completed

• 1 other identifier: spinal manipulation
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

disability evaluation; musculoskeletal manipulations; neck pain; spinal manipulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Change in flexion movement: Cervical Range of Motion device

  Baseline and 7 days post-treatment

• Change in extension movement: Cervical Range of Motion device

  Baseline and 7 days post-treatment

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

  Baseline and 7 days post-treatment

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

  Baseline and 7 days post-treatment

• Change in right rotation movement: Cervical Range of Motion device

  Baseline and 7 days post-treatment

Study Arms (2)

Upper cervical spine manipulation group

EXPERIMENTAL

Spinal thrust joint manipulation on the atlantoaxial joint

Other: Spinal manipulation

Cervicothoracic spine manipulations group

ACTIVE COMPARATOR

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

Other: Spinal manipulation

Interventions

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.

Cervicothoracic spine manipulations group; Upper cervical spine manipulation group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clínica Ciudad de Almería: lead

Study Sites (1)

Clínica Ciudad de Almería

Almería, 04008, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Raúl Romero del Rey, Mr

  Clinica Ciudad de Almería

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 6, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

ES (1)