Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches

NCT03919630 | Completed

• 1 other identifier: JC432019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently a gap within the literature as to the effects of a thrust versus non-thrust mobilizations techniques specifically to the upper cervical spine C0-C3 along with home exercise program to help reduce frequency and intensity of cervicogenic headaches. Therefore, the purpose of this study is to examine the effectiveness of in treating headaches using non-thrust or thrust mobilizations in addition to postural corrective exercises on patient outcomes measures.

Conditions

Cervicogenic Headache

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  The Neck Disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

  Baseline, 4-weeks and 1-month follow-up

Secondary Outcomes (5)

• Numeric Pain Rating scale

  Baseline, 1 hour, 48 hours, 4-weeks and 1-month follow-up

• Headache Impact Test

  Baseline, 4-weeks and 1-month follow-up

• Global Rating of Change Scale

  48 hours, 4-weeks and 1-month follow-up

• Patient Acceptable Symptom State

  4-weeks and 1-month follow-up

• Active cervical range of motion

  Baseline, 1 hour, 48 hours, 4-weeks

Study Arms (2)

Cervical Thrust Mobilizations

EXPERIMENTAL

Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine.

Other: Thrust Mobilization

Cervical Non-Thrust Mobilizations

ACTIVE COMPARATOR

Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.

Other: Non-Thrust Mobilizations

Interventions

Thrust Mobilization OTHER

Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine

Cervical Thrust Mobilizations

Non-Thrust Mobilizations OTHER

Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.

Cervical Non-Thrust Mobilizations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be English-speaking and have appropriate medical literacy to participate in the study
• The physical examination must yield a reproducible familiar/concordant neck, head, jaw symptom or dysfunction
• Pain reports of at least 2/10 for a headache or neck pain intensity
• Neck Disability reports of at least a 20% or greater impact
• Patients that report having at least two headaches within one month

You may not qualify if:

• The presence of any know red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• Patients who exhibit any red flag symptoms: positive upper or lower motor neuron testing. Signs or symptoms consistent cervical myelopathy or radiculopathy with nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome
• Patients who exhibit any red flag symptoms of cervical instability tests, or have a positive VBI or CAD testing, showing signs of the 5 D's (dizziness, drop attacks, dysarthria, dysphagia, diplopia) or patient who have signs of 3 N's (Nystagmus, nausea, other neurological symptoms).
• Prior surgery to the cervical spine or head (including cerebral shunts)
• Women who are pregnant in their third trimester

Sponsors & Collaborators

• Franklin Pierce University: lead

Study Sites (1)

Pain Relief and Physical Therapy

Havertown, Pennsylvania, 19083, United States

Location

Related Publications (1)

• Lerner-Lentz A, O'Halloran B, Donaldson M, Cleland JA. Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial. J Man Manip Ther. 2021 Oct;29(5):267-275. doi: 10.1080/10669817.2020.1834322. Epub 2020 Nov 5.

  PMID: 33148134 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 18, 2019
• Study Start: May 1, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)