Clinical trial NCT04546165: Manual Therapy in Tension-type Headache
Official title: Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in TTH management

Detailed description: Increased cranio-cervical muscle sensitivity is the most prominent finding in TTH. Also, neck pain is markedly more common in individuals with TTH compared with the control population (88.4%, and 56.7%, respectively). Therefore, current research on the pathogenesis of TTH focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. It has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (CNS) due to long-term nociceptive stimuli may play a role in development and chronification of TTH

Eligibility criteria: Inclusion Criteria:

* diagnosis of TTH was made based on the International Classification of Headache Disorders criteria, third edition (ICHD-3 beta)
* (bilateral localization, pressing and tightening pain, mild-moderate intensity \[≤7.0 on a visual analog scale (VAS)\]
* no increase in pain during physical activity
* patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ICHD-III diagnostic criteria
* had symptoms for more than 3 months
* the patients had to have had at least one segmental dysfunction of the upper cervical spine in all groups (by functional and pain-provocation tests).

Exclusion Criteria:

* any other primary or secondary headache according to the ICHD-III criteria
* a history of neck or head trauma (e.g., whiplash)
* any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use)
* diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis)
* prior surgery to the cervical spine
* application of other treatment methods such as physical therapy or anesthetic block to the head and neck area within the last 3 months
* initiation of pharmacologic prophylaxis within two months prior to randomization
* pregnancy

Primary outcomes:
measure: Headache Frequency (HF)
timeFrame: Changes from baseline in Headache Frequency Score to 1 month and 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Changes from baseline in Visual Analog Scale Score to 1 month and 3 months
measure: Headache Impact Test-6 (HIT-6)
timeFrame: Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months
measure: Neck Disability Index (NDI)
timeFrame: Changes from baseline in Neck Disability Index Score to 1 month and 3 months
measure: Pressure-Pain Threshold (PTT)
timeFrame: Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Mustafa Corum, MD
role: STUDY_CHAIR
References: