Manual Therapy in Tension-type Headache

Not Applicable

Completed

• Conditions: Tension-Type Headache
• Interventions: Procedure: suboccipital inhibition plus exercise; Procedure: manipulation plus exercise; Procedure: exercise

• Registration Number: NCT04546165
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Study Timeline

• Study Start: 2020-06-22
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Study First Posted: 2020-09-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manipulation group	suboccipital inhibition plus exercise	manipulation plus exercise
manipulation group	exercise	manipulation plus exercise
myofascial release group	exercise	suboccipital inhibition plus exercise
exercise group	suboccipital inhibition plus exercise	only exercise
myofascial release group	manipulation plus exercise	suboccipital inhibition plus exercise
exercise group	manipulation plus exercise	only exercise

Primary Outcome Measures

Name	Time	Method
Headache Frequency (HF)	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 Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Changes from baseline in Visual Analog Scale Score to 1 month and 3 months	The self-evaluation of pain severity of headache and neck pain during rest and activity in the previous week was calculated using a 10-cm VAS scale, where 0 in the left corner of the scale represented 'no pain' and 10 in the right corner represented 'the worst pain that could be imagined'
Headache Impact Test-6 (HIT-6)	Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months	The total score was calculated in HIT-6, which consisted of 6 questions with 5 answer options for each (never: 6 points, rarely: 8 points, sometimes: 10 points, very often: 11 points, always: 13 points). A total score of 36 means best and 78 means worst in terms of headache
Neck Disability Index (NDI)	Changes from baseline in Neck Disability Index Score to 1 month and 3 months	The NDI consists of 10 questions about pain disability in the neck region ("no disability" = 0, and "full disability" = 5). The total NDI score was calculated, with 0 showing the best score and 50 showing the worst score.
Pressure-Pain Threshold (PTT)	Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months	PPT measurements were performed using a mechanical pressure algometer on the temporalis anterior muscle The feeling of pressure was gradually increased until it turned into pain or discomfort, at which point the pressure value was recorded.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey