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Manual Therapy in Tension-type Headache

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04546165
Enrollment
45
Registered
2020-09-11
Start date
2020-06-22
Completion date
2020-09-10
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-Type Headache

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

Interventions

PROCEDUREmanipulation 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

PROCEDUREsuboccipital 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

PROCEDUREexercise

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).

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Visual Analog Scale (VAS)Changes from baseline in Visual Analog Scale Score to 1 month and 3 monthsThe 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 monthsThe 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 monthsThe 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 monthsPPT 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026