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Clinical Trials/NCT04546165
NCT04546165
Completed
Not Applicable

Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 site in 1 country45 target enrollmentJune 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tension-Type Headache
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Enrollment
45
Locations
1
Primary Endpoint
Headache Frequency (HF)
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 22, 2020
End Date
September 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mustafa Corum

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Outcomes

Primary Outcomes

Headache Frequency (HF)

Time Frame: Changes from baseline in Headache Frequency Score to 1 month and 3 months

. Headache frequency was measured as the total number of days with headache (days/2-week) in the previous 2 weeks.

Secondary Outcomes

  • Visual Analog Scale (VAS)(Changes from baseline in Visual Analog Scale Score to 1 month and 3 months)
  • Headache Impact Test-6 (HIT-6)(Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months)
  • Neck Disability Index (NDI)(Changes from baseline in Neck Disability Index Score to 1 month and 3 months)
  • Pressure-Pain Threshold (PTT)(Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months)

Study Sites (1)

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