Manual Therapy in Tension-type Headache

Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546165
• Other study ID #: 2020/289
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: September 10, 2020

Study information

• Verified date: November 2020
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Procedure:
• manipulation plus exercise
HLVA manipulation was performed for 8 sessions (twice a week for four weeks) using a segment-specific technique for segmental dysfunctions of the upper cervical spine. . By bringing the cervical spine to light flexion and about 15-20º lateral flexion without any rotational motion, the middle finger of the manipulating hand provided deep contact, and an HVLA thrust was applied out of the rotational slack by applying a deep force from the dorsal to the ventral direction
• suboccipital inhibition plus exercise
Suboccipital inhibition was performed for 8 sessions (twice a week for four weeks) as a combined muscle and soft tissue inhibition technique. While the patient was in the supine position, the physician sitting at the top end of the table placed the fingers of both hands on the patient's suboccipital region
• exercise
Patients were asked to exercise at least three days a week during treatment. The exercise program, which lasted 20 to 30 minutes, included cervical range of motion (ROM) exercises to warm-up and cool-down, and then stretching exercises of cervical and upper thoracic spine muscles (trapezius, levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric contraction and concentric contraction of the deep cervical flexor muscles).

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Frequency (HF)	. Headache frequency was measured as the total number of days with headache (days/2-week) in the previous 2 weeks.	Changes from baseline in Headache Frequency Score to 1 month and 3 months
Secondary	Visual Analog Scale (VAS)	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'	Changes from baseline in Visual Analog Scale Score to 1 month and 3 months
Secondary	Headache Impact Test-6 (HIT-6)	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	Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months
Secondary	Neck Disability Index (NDI)	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.	Changes from baseline in Neck Disability Index Score to 1 month and 3 months
Secondary	Pressure-Pain Threshold (PTT)	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.	Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months