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The Safety and Feasibility of tDCS Combined With Conservative Treatment for Cervicogenic Headaches

Primary Purpose

Cervicogenic Headache

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Transcranial Direct Current Stimulation, Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with cervicogenic headaches based on International Headache Society Guidelines lasting greater than 12 weeks
  • The International Headache Society Guidelines are as follows: A) Presence of a headache fulfilling criterion C; B) Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache; C) Evidence of causation demonstrated by at least two of the following: (a) Headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion; (b) Headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion; (c) Cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers; (d) Headache is abolished following diagnostic blockade of a cervical structure or its nerve supply.
  • Average pain score ≥ 4/10 and Neck Disability score ≥ 28/50

Exclusion Criteria:

  • Presence of primary or mixed headaches (ie. Migraines and tension type headaches)
  • Known spinal pathology (tumour, fracture, etc)
  • Nerve root pain/sensory loss
  • Muscular or joint inflammatory conditions
  • Neurological or psychiatric conditions
  • Undergone recent surgery (within prior year)
  • Have contraindications to tDCS (metal or electronic implants in the brain/skull; metal or electronic implants in other sites on the body; surgical procedures involving the head or spinal cord; skin problems such as dermatitis, psoriasis or eczema; epilepsy or a previous convulsion/seizure; fainting spells or syncope; pregnancy or any chance of pregnancy; previous electrical or magnetic stimulation)

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS with physiotherapy

Sham tDCS with physiotherapy

Arm Description

Patients will engage in a six-week treatment protocol with 3 sessions per week (18 treatments). This was chosen to minimize discomfort and ensure the number of sessions is consistent with previous migraine literature. The primary motor cortex (M1) will be the treatment target to reduce pain sensitivity and improve motor learning. M1 will be found through measurements of the head: the point halfway between the nasion and inion and halfway between the left and right tragus will be found, we will then move down 20% of the inter-tragi distance and place the anode there. The cathode will then be placed over the super orbital region. Each electrode will be held in place with a strap and will make as much contact with the skin as possible. tDCS will be delivered via two 35cm2 surface sponge electrodes at an intensity of 2mA in the active group.

In the sham condition, the number of sessions, placement of electrodes, and types of electrodes used will be the same, however, only a 30 second ramp up period will be administered to emulate active tDCS therapy. Patients will be able to hear the sounds of the device and will feel slight tingling for the first 30 seconds but will receive no active stimulation. Previous sham studies have demonstrated efficacy of the blinding method.

Outcomes

Primary Outcome Measures

Feasibility of tDCS through change in participant rate, change in pain intensity, frequency, and duration, and change in medication usage
The feasibility of tDCS will be measured through changes in participant enrolment and dropout rates.
Safety of tDCS through change in adverse effect rates from before treatment to after.
The safety of tDCS will primarily be measured through changes in safety questionnaire scores, and medication usage. Safety questionnaires ask participants to rate commonly experienced symptoms from 0-100 (0= "Not occurring", 100 = "Most severe"). The symptoms assessed are itchiness, tingling, burning sensations, headache, fatigue, nausea, and mood difficulties.

Secondary Outcome Measures

European Quality of Life Five Dimension (EQ-5D)
Quality of life will be measured via the European Quality of Life Five Dimension (EQ-5D). Ranges from 0-25 with higher scores indicating reduced quality of life.
Headache Impact Test 6 (HIT-6)
Headache intensity will be measured via the Headache Intensity Test - 6 (HIT-6). This test ranges between a score of 36 and 78 with higher scores meaning increased headache intensity and frequency.
Headache Disability Index (HDI)
Headache effects on participant function will be measured via the Headache Disability Index (HDI). Scores on this index range from 0-100 with higher scores indicating more severe disability as a result of headaches.
Pain Catastrophizing Scale (PCS)
Pain sensitivity will be measured via the Pain Catastrophizing Scale (PCS). Scores on this scale range from 0-52 with higher scores indicating greater sensitivity to pain.
PROMIS Pain Interference Scale
Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale. Ranges from 4-20 with increasing scores meaning increased pain interference in daily life.
Craniocervical Flexion Test (CCFT)
Fine motor control of neck muscles will be measured via the Craniocervical Flexion Test (CCFT).
Cervical Extensor Endurance Test (CEET)
Neck muscle endurance will be measured via the Cervical Extensor Endurance Test (CEET).
Dynamometry Neck-Strength Assessment (DNSA)
Neck muscle strength will be measured via the Dynamometry Neck-Strength Assessment (DNSA).
Patient health questionnaire 9 (PHQ-9)
Depression will be measured via the patient health questionnaire-9 (PHQ-9). Ranges from 0-27 with higher scores meaning more depressive symptoms.
Generalized anxiety disorder scale 7 (GADS-7)
Anxiety will be measured via the generalized anxiety disorder scale-7 (GADS-7). Ranges from 0-21 with her scores meaning more symptoms of anxiety.
Cervical Flexor Endurance Test (CFET)
Neck muscle endurance will be measured via the Cervical Flexor Endurance Test (CFET) as well.
Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed through the numeric pain rating scale (NPRS). This scale ranges from 0-10 with a higher score indicating more pain intensity.
Medication usage as measured by the quantitative analgesics questionnaire.
Measure a decline, increase or stoppage of medication throughout the study.

Full Information

First Posted
August 22, 2022
Last Updated
November 30, 2022
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT05582616
Brief Title
The Safety and Feasibility of tDCS Combined With Conservative Treatment for Cervicogenic Headaches
Official Title
The Safety and Feasibility of Transcranial Direct Current Stimulation Combined With Conservative Treatment for Cervicogenic Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Annually, up to 150,000 individuals are affected by cervicogenic headaches (CGH) in Canada with many of these cases being chronic. Current treatments for CGH are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial direct current stimulation (tDCS) and physiotherapy have a high degree of safety and have been studied as interventions for many other chronic pain conditions and headache disorders. We propose to study the feasibility and safety of tDCS alongside physiotherapy for CGH further in a randomized sham controlled trial.
Detailed Description
Annually, up to 150,000 people in Canada and experience cervicogenic headaches (CGH) with many of these patients suffering from chronic CGH. CGH is a pain disorder where pain is perceived in the head but caused by dysfunction of the cervical spine and its anatomical structure. More specifically, the pathogenesis of CGH is due to the convergence of nociceptive afferents from the upper three cervical nerves and trigeminal nerves onto second-order neurons in the trigeminocervical nucleus. The pain signaling resulting from this is also modulated through sensorineural pathways involving the thalamus and the sensorimotor cortex. As such symptoms of CGH include restricted movement, local tenderness of the upper cervical spine joints, musculoskeletal impairments, headache, local pressure hyperalgesia and bilateral thermal hypoesthesia. To date, there is no "cure" for chronic CGH and current treatment entails trial and error with behavior management, environmental modifications and medications. Consequently, there is a significant need for new approaches to symptom management in order to help improve functional impairment and disease burden associated with treating CGH. Transcranial direct current stimulation (tDCS) and physiotherapy have a high degree of safety and have been studied as an intervention for many other chronic pain conditions and headache disorders, including arthritis and migraines, demonstrating considerable potential. The investigators propose to study the safety and feasibility of tDCS alongside physiotherapy as a treatment for CGH in a randomized sham controlled trial. RESEARCH QUESTIONS AND OBJECTIVES The overall objective is to study the feasibility and safety of tDCS applied to the primary motor cortex in patients with CGH and to explore whether active tDCS augments the effect of rehabilitation therapy. Specifically the objectives are: Primary Objective: To determine whether active tDCS is feasible and safe compared to sham when administered with rehabilitation therapy for patients with CGH when administered 3 times per week over the course of 6 weeks; this will be measured with patient drop out rates, medication use, and adverse effects throughout the treatment process and at 6- and 12- weeks post treatment. Secondary Objective: To determine what secondary outcomes such as quality of life, headaches, pain sensitivity, neck mobility, anxiety, and depression improve with active tDCS treatment in individuals suffering with CGH. Quality of life will be measured via the European Quality of Life Five Dimension (EQ-5D), headache intensity will be measured via the Headache Intensity Test - 6 (HIT-6), headache effects on participant function will be measured via the Headache Disability Index (HDI), pain sensitivity will be measured via the Pain Sensitivity Questionnaire (PSQ), neck mobility will be measured through various motor control, strength, and endurance tests, feelings of depression will be measured via the PHQ-9 and anxiety via the GADS-7 before treatment after treatment and at 6- and 12- weeks post treatment. Third objective: To explore whether the effects of active tDCS will augment the effects of rehabilitation therapy in treating individuals with CGH. METHODS This study will be a double-blind, sham-controlled, concealed allocation, randomized, clinical trial. Clinical Assessments: Demographic information will be collected two weeks prior to starting the study including age, sex, education, headache history, concussion history, past medical history, medication use, and family medical history. Baseline questionnaires will be completed including Headache Impact Test - 6 (HIT-6), Rivermead PPCS questionnaire, Headache Disability Index (HDI), European Quality of Life Five Dimension (EQ-5D), Section A of the Quantitative Analgesics Questionnaire (QAQ-A), patient health questionnaire-9 (PHQ-9), generalized anxiety disorder scale-7 (GADS-7), Patient Reported Outcomes Measurement Information System (PROMIS), and the Pain Catastrophizing Scale (PCS). Furthermore the following baseline neck mobility assessments will be used: the Craniocervical Flexion Test (CCFT), the Cervical Extensor Endurance Test (CEET), and the Dynamometry Neck-Strength Assessment (DNSA). Patients will keep a two-week baseline headache diary before treatment, 2 weeks during treatment, 2 weeks following tDCS, and for 2 weeks before the 6 and 12 week follow up assessments (total of 8 weeks). Patients will be reassessed at the completion of their tDCS treatment, and at 6- and 12-weeks post-treatment. The assessments administered at each follow up are: Rivermead PPCS questionnaire, HIT-6, HDI, SF-12, PHQ-9, GAD-7, QAQ-A, NPRS, PSQ, CCFT, CEET, DNSA, and a tDCS Attitudes and Impressions Survey. tDCS Protocol: Patients will engage in a six-week treatment protocol with 3 sessions per week (18 treatments). This was chosen to give participants at least a day between each session in order to minimize discomfort and because the number of sessions is consistent with previous migraine literature. The primary motor cortex (M1) will be the treatment target given previous literature highlighting reduced pain sensitivity and improved motor learning outcomes following tDCS stimulation of this region. M1 will be found through measurements of the head; more specifically the point halfway between the nasion and inion as well as halfway between the left and right tragus will be found, from here we will move down 20% of the distance between the left and right tragus while staying on the line between tragi. The anode will be placed over the M1 while the cathode will be placed over the super orbital region; each electrode will be held in place with a strap and will make as much contact with the skin as possible. tDCS will be delivered via two 35cm2 surface sponge electrodes at an intensity of 2mA in the active group and 0mA in the sham group. There will be a 30 second fade in and fade out period before and after stimulation with 20 minutes of active stimulation. In the sham condition, participants will only experience the 30 second fade in period and then the stimulator will be turned off. Previous sham studies have demonstrated the efficacy of this blinding method. Physiotherapy Protocol: Participants will engage in a six-week physiotherapy program which will occur immediately following each tDCS session. The exercises to be used focus on head and back strength and motor control and were assembled by a licensed physiotherapist based on previous physiotherapy protocols for treating CGH. The exercises are performed at a level that is pain-free and are progressed when goals are reached (approximately every 2 weeks). Participants will also be expected to increase daily physical activity levels to 30 minutes per day for at least 5 days a week as a part of the physiotherapy program. This will be tracked using an exercise diary to be completed by participants each day. Statistical Analysis: Summary statistics will be done and reported so that feasibility and safety can be assessed and future studies can use the results presented for power calculations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Transcranial Direct Current Stimulation, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized placebo controlled clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, researcher, and care providers will be blinded until after the analysis period, researchers will be assessing outcomes.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS with physiotherapy
Arm Type
Experimental
Arm Description
Patients will engage in a six-week treatment protocol with 3 sessions per week (18 treatments). This was chosen to minimize discomfort and ensure the number of sessions is consistent with previous migraine literature. The primary motor cortex (M1) will be the treatment target to reduce pain sensitivity and improve motor learning. M1 will be found through measurements of the head: the point halfway between the nasion and inion and halfway between the left and right tragus will be found, we will then move down 20% of the inter-tragi distance and place the anode there. The cathode will then be placed over the super orbital region. Each electrode will be held in place with a strap and will make as much contact with the skin as possible. tDCS will be delivered via two 35cm2 surface sponge electrodes at an intensity of 2mA in the active group.
Arm Title
Sham tDCS with physiotherapy
Arm Type
Sham Comparator
Arm Description
In the sham condition, the number of sessions, placement of electrodes, and types of electrodes used will be the same, however, only a 30 second ramp up period will be administered to emulate active tDCS therapy. Patients will be able to hear the sounds of the device and will feel slight tingling for the first 30 seconds but will receive no active stimulation. Previous sham studies have demonstrated efficacy of the blinding method.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
See treatment arm description
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
See sham comparator arm description
Primary Outcome Measure Information:
Title
Feasibility of tDCS through change in participant rate, change in pain intensity, frequency, and duration, and change in medication usage
Description
The feasibility of tDCS will be measured through changes in participant enrolment and dropout rates.
Time Frame
To be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up
Title
Safety of tDCS through change in adverse effect rates from before treatment to after.
Description
The safety of tDCS will primarily be measured through changes in safety questionnaire scores, and medication usage. Safety questionnaires ask participants to rate commonly experienced symptoms from 0-100 (0= "Not occurring", 100 = "Most severe"). The symptoms assessed are itchiness, tingling, burning sensations, headache, fatigue, nausea, and mood difficulties.
Time Frame
To be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up
Secondary Outcome Measure Information:
Title
European Quality of Life Five Dimension (EQ-5D)
Description
Quality of life will be measured via the European Quality of Life Five Dimension (EQ-5D). Ranges from 0-25 with higher scores indicating reduced quality of life.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Headache Impact Test 6 (HIT-6)
Description
Headache intensity will be measured via the Headache Intensity Test - 6 (HIT-6). This test ranges between a score of 36 and 78 with higher scores meaning increased headache intensity and frequency.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Headache Disability Index (HDI)
Description
Headache effects on participant function will be measured via the Headache Disability Index (HDI). Scores on this index range from 0-100 with higher scores indicating more severe disability as a result of headaches.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Pain Catastrophizing Scale (PCS)
Description
Pain sensitivity will be measured via the Pain Catastrophizing Scale (PCS). Scores on this scale range from 0-52 with higher scores indicating greater sensitivity to pain.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
PROMIS Pain Interference Scale
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale. Ranges from 4-20 with increasing scores meaning increased pain interference in daily life.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Craniocervical Flexion Test (CCFT)
Description
Fine motor control of neck muscles will be measured via the Craniocervical Flexion Test (CCFT).
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Cervical Extensor Endurance Test (CEET)
Description
Neck muscle endurance will be measured via the Cervical Extensor Endurance Test (CEET).
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Dynamometry Neck-Strength Assessment (DNSA)
Description
Neck muscle strength will be measured via the Dynamometry Neck-Strength Assessment (DNSA).
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Patient health questionnaire 9 (PHQ-9)
Description
Depression will be measured via the patient health questionnaire-9 (PHQ-9). Ranges from 0-27 with higher scores meaning more depressive symptoms.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Generalized anxiety disorder scale 7 (GADS-7)
Description
Anxiety will be measured via the generalized anxiety disorder scale-7 (GADS-7). Ranges from 0-21 with her scores meaning more symptoms of anxiety.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Cervical Flexor Endurance Test (CFET)
Description
Neck muscle endurance will be measured via the Cervical Flexor Endurance Test (CFET) as well.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Numeric Pain Rating Scale (NPRS)
Description
Pain intensity will be assessed through the numeric pain rating scale (NPRS). This scale ranges from 0-10 with a higher score indicating more pain intensity.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Title
Medication usage as measured by the quantitative analgesics questionnaire.
Description
Measure a decline, increase or stoppage of medication throughout the study.
Time Frame
To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Other Pre-specified Outcome Measures:
Title
Headache Diary
Description
Daily diary for participants to report the frequency, duration, intensity, and location of headaches.
Time Frame
To be completed 2 weeks prior to treatment, 2 weeks after treatment, 2 weeks prior to 6 week assessment, and 2 weeks prior to 12 week assessment for a total of 8 weeks.
Title
Exercise diary
Description
Daily diary for participants to report the intensity and duration of their exercise activities.
Time Frame
To be completed each day for the duration of treatment (6 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with cervicogenic headaches based on International Headache Society Guidelines lasting greater than 12 weeks The International Headache Society Guidelines are as follows: A) Presence of a headache fulfilling criterion C; B) Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache; C) Evidence of causation demonstrated by at least two of the following: (a) Headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion; (b) Headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion; (c) Cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers; (d) Headache is abolished following diagnostic blockade of a cervical structure or its nerve supply. Average pain score ≥ 4/10 and Neck Disability score ≥ 28/50 Exclusion Criteria: Presence of primary or mixed headaches (ie. Migraines and tension type headaches) Known spinal pathology (tumour, fracture, etc) Nerve root pain/sensory loss Muscular or joint inflammatory conditions Neurological or psychiatric conditions Undergone recent surgery (within prior year) Have contraindications to tDCS (metal or electronic implants in the brain/skull; metal or electronic implants in other sites on the body; surgical procedures involving the head or spinal cord; skin problems such as dermatitis, psoriasis or eczema; epilepsy or a previous convulsion/seizure; fainting spells or syncope; pregnancy or any chance of pregnancy; previous electrical or magnetic stimulation)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chantel T Debert, MD MSc FRCPC CSCN
Phone
(403) 944-4500
Email
cdebert@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kaiden D Jobin, BHSc
Phone
(403)-944-8643
Email
kaiden.jobin1@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantel T Debert, MD MSc FRCPC CSCN
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantel T Debert, MD MSc FRCPC CSCN
Phone
(403) 944-4500
Email
cdebert@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Kaiden D Jobin, BHSc
Phone
(403)-944-8643
Email
kaiden.jobin1@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31246881
Citation
Langer L, Levy C, Bayley M. Increasing Incidence of Concussion: True Epidemic or Better Recognition? J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E60-E66. doi: 10.1097/HTR.0000000000000503.
Results Reference
background
PubMed Identifier
7838578
Citation
Barnsley L, Lord S, Bogduk N. Whiplash injury. Pain. 1994 Sep;58(3):283-307. doi: 10.1016/0304-3959(94)90123-6. No abstract available.
Results Reference
background
PubMed Identifier
16485074
Citation
Sjaastad O, Fredriksen TA, Batnes J, Petersen HC, Bakketeig LS. Whiplash in individuals with known pre-accident, clinical neck status. J Headache Pain. 2006 Feb;7(1):9-20. doi: 10.1007/s10194-006-0270-x. Epub 2006 Feb 20.
Results Reference
background
PubMed Identifier
7931379
Citation
Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.
Results Reference
background
PubMed Identifier
448382
Citation
Lindblom U, Verrillo RT. Sensory functions in chronic neuralgia. J Neurol Neurosurg Psychiatry. 1979 May;42(5):422-35. doi: 10.1136/jnnp.42.5.422.
Results Reference
background
PubMed Identifier
9950624
Citation
Becser N, Sand T, Pareja JA, Zwart JA. Thermal sensitivity in unilateral headaches. Cephalalgia. 1998 Dec;18(10):675-83; discussion 657. doi: 10.1046/j.1468-2982.1998.1810675.x.
Results Reference
background
PubMed Identifier
19747657
Citation
Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
Results Reference
background
PubMed Identifier
11403743
Citation
Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
Results Reference
background
PubMed Identifier
11903282
Citation
Dumas JP, Arsenault AB, Boudreau G, Magnoux E, Lepage Y, Bellavance A, Loisel P. Physical impairments in cervicogenic headache: traumatic vs. nontraumatic onset. Cephalalgia. 2001 Nov;21(9):884-93. doi: 10.1046/j.1468-2982.2001.00264.x.
Results Reference
background
PubMed Identifier
29200944
Citation
Manchikanti L, Pampati V, Kaye AD, Hirsch JA. Cost Utility Analysis of Cervical Therapeutic Medial Branch Blocks in Managing Chronic Neck Pain. Int J Med Sci. 2017 Oct 15;14(13):1307-1316. doi: 10.7150/ijms.20755. eCollection 2017.
Results Reference
background
PubMed Identifier
27065472
Citation
Frazer A, Williams J, Spittles M, Rantalainen T, Kidgell D. Anodal transcranial direct current stimulation of the motor cortex increases cortical voluntary activation and neural plasticity. Muscle Nerve. 2016 Nov;54(5):903-913. doi: 10.1002/mus.25143. Epub 2016 May 20.
Results Reference
background
PubMed Identifier
25996937
Citation
Rroji O, van Kuyck K, Nuttin B, Wenderoth N. Anodal tDCS over the Primary Motor Cortex Facilitates Long-Term Memory Formation Reflecting Use-Dependent Plasticity. PLoS One. 2015 May 21;10(5):e0127270. doi: 10.1371/journal.pone.0127270. eCollection 2015.
Results Reference
background
PubMed Identifier
31285791
Citation
Zaninotto AL, El-Hagrassy MM, Green JR, Babo M, Paglioni VM, Benute GG, Paiva WS. Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. Dement Neuropsychol. 2019 Apr-Jun;13(2):172-179. doi: 10.1590/1980-57642018dn13-020005.
Results Reference
background
PubMed Identifier
26029083
Citation
Wessel MJ, Zimerman M, Hummel FC. Non-invasive brain stimulation: an interventional tool for enhancing behavioral training after stroke. Front Hum Neurosci. 2015 May 15;9:265. doi: 10.3389/fnhum.2015.00265. eCollection 2015.
Results Reference
background
PubMed Identifier
29652088
Citation
O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.
Results Reference
background
PubMed Identifier
33070785
Citation
Begemann MJ, Brand BA, Curcic-Blake B, Aleman A, Sommer IE. Efficacy of non-invasive brain stimulation on cognitive functioning in brain disorders: a meta-analysis. Psychol Med. 2020 Nov;50(15):2465-2486. doi: 10.1017/S0033291720003670. Epub 2020 Oct 19.
Results Reference
background
PubMed Identifier
30671941
Citation
Stilling JM, Monchi O, Amoozegar F, Debert CT. Transcranial Magnetic and Direct Current Stimulation (TMS/tDCS) for the Treatment of Headache: A Systematic Review. Headache. 2019 Mar;59(3):339-357. doi: 10.1111/head.13479. Epub 2019 Jan 23.
Results Reference
background
PubMed Identifier
32289696
Citation
Rahimi MD, Fadardi JS, Saeidi M, Bigdeli I, Kashiri R. Effectiveness of cathodal tDCS of the primary motor or sensory cortex in migraine: A randomized controlled trial. Brain Stimul. 2020 May-Jun;13(3):675-682. doi: 10.1016/j.brs.2020.02.012. Epub 2020 Feb 14.
Results Reference
background
PubMed Identifier
28566169
Citation
Andrade SM, de Brito Aranha REL, de Oliveira EA, de Mendonca CTPL, Martins WKN, Alves NT, Fernandez-Calvo B. Transcranial direct current stimulation over the primary motor vs prefrontal cortex in refractory chronic migraine: A pilot randomized controlled trial. J Neurol Sci. 2017 Jul 15;378:225-232. doi: 10.1016/j.jns.2017.05.007. Epub 2017 May 3.
Results Reference
background
PubMed Identifier
26852024
Citation
Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
Results Reference
background
PubMed Identifier
32621321
Citation
Fernandez M, Moore C, Tan J, Lian D, Nguyen J, Bacon A, Christie B, Shen I, Waldie T, Simonet D, Bussieres A. Spinal manipulation for the management of cervicogenic headache: A systematic review and meta-analysis. Eur J Pain. 2020 Oct;24(9):1687-1702. doi: 10.1002/ejp.1632. Epub 2020 Jul 20.
Results Reference
background
PubMed Identifier
22460941
Citation
Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
Results Reference
background
PubMed Identifier
31377178
Citation
Debarnot U, Neveu R, Samaha Y, Saruco E, Macintyre T, Guillot A. Acquisition and consolidation of implicit motor learning with physical and mental practice across multiple days of anodal tDCS. Neurobiol Learn Mem. 2019 Oct;164:107062. doi: 10.1016/j.nlm.2019.107062. Epub 2019 Aug 1.
Results Reference
background
PubMed Identifier
23316151
Citation
Lefebvre S, Laloux P, Peeters A, Desfontaines P, Jamart J, Vandermeeren Y. Dual-tDCS Enhances Online Motor Skill Learning and Long-Term Retention in Chronic Stroke Patients. Front Hum Neurosci. 2013 Jan 9;6:343. doi: 10.3389/fnhum.2012.00343. eCollection 2012.
Results Reference
background
PubMed Identifier
27679565
Citation
Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
Results Reference
background
PubMed Identifier
28709880
Citation
Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
Results Reference
background
PubMed Identifier
30707486
Citation
Cote P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, Ameis A, Carroll LJ, Nordin M, Varatharajan S, Sutton D, Southerst D, Jacobs C, Stupar M, Taylor-Vaisey A, Gross DP, Brison RJ, Paulden M, Ammendolia C, Cassidy JD, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M. Non-pharmacological management of persistent headaches associated with neck pain: A clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain. 2019 Jul;23(6):1051-1070. doi: 10.1002/ejp.1374. Epub 2019 Feb 28.
Results Reference
background
PubMed Identifier
34374330
Citation
Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
Results Reference
background
PubMed Identifier
33079313
Citation
Houts CR, McGinley JS, Wirth RJ, Cady R, Lipton RB. Reliability and validity of the 6-item Headache Impact Test in chronic migraine from the PROMISE-2 study. Qual Life Res. 2021 Mar;30(3):931-943. doi: 10.1007/s11136-020-02668-2. Epub 2020 Oct 20.
Results Reference
background
PubMed Identifier
16323387
Citation
Eyres S, Carey A, Gilworth G, Neumann V, Tennant A. Construct validity and reliability of the Rivermead Post-Concussion Symptoms Questionnaire. Clin Rehabil. 2005 Dec;19(8):878-87. doi: 10.1191/0269215505cr905oa.
Results Reference
background
PubMed Identifier
34816697
Citation
Jabbari S, Salahzadeh Z, Sarbakhsh P, Rezaei M, Farhoudi M, Ghodrati M. Validity and Reliability of Persian Version of Henry Ford Hospital Headache Disability Inventory Questionnaire. Arch Iran Med. 2021 Oct 1;24(10):752-758. doi: 10.34172/aim.2021.111.
Results Reference
background
PubMed Identifier
25912277
Citation
Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
18388841
Citation
Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
Results Reference
background
PubMed Identifier
29856244
Citation
Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
Results Reference
background
PubMed Identifier
20146239
Citation
James G, Doe T. The craniocervical flexion test: intra-tester reliability in asymptomatic subjects. Physiother Res Int. 2010 Sep;15(3):144-9. doi: 10.1002/pri.456.
Results Reference
background
PubMed Identifier
25892374
Citation
Sebastian D, Chovvath R, Malladi R. Cervical extensor endurance test: a reliability study. J Bodyw Mov Ther. 2015 Apr;19(2):213-6. doi: 10.1016/j.jbmt.2014.04.014. Epub 2014 Apr 18.
Results Reference
background
PubMed Identifier
25931654
Citation
Versteegh T, Beaudet D, Greenbaum M, Hellyer L, Tritton A, Walton D. Evaluating the reliability of a novel neck-strength assessment protocol for healthy adults using self-generated resistance with a hand-held dynamometer. Physiother Can. 2015 Winter;67(1):58-64. doi: 10.3138/ptc.2013-66.
Results Reference
background
PubMed Identifier
33050340
Citation
Cleland BT, Galick M, Huckstep A, Lenhart L, Madhavan S. Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Brain Sci. 2020 Oct 9;10(10):719. doi: 10.3390/brainsci10100719.
Results Reference
background
PubMed Identifier
9429990
Citation
Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.
Results Reference
background
PubMed Identifier
19475674
Citation
Stark RG, Reitmeir P, Leidl R, Konig HH. Validity, reliability, and responsiveness of the EQ-5D in inflammatory bowel disease in Germany. Inflamm Bowel Dis. 2010 Jan;16(1):42-51. doi: 10.1002/ibd.20989.
Results Reference
background
PubMed Identifier
16305273
Citation
Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
Results Reference
background

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The Safety and Feasibility of tDCS Combined With Conservative Treatment for Cervicogenic Headaches

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