- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546165
Manual Therapy in Tension-type Headache
November 19, 2020 updated by: Mustafa Corum, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bahcelievler
-
Istanbul, Bahcelievler, Turkey, 34180
- Istanbul Physical Medicine and Rehabilitation Training and research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: manipulation group
manipulation 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
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).
|
Active Comparator: myofascial release group
suboccipital inhibition plus 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).
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
|
Active Comparator: exercise group
only 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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Changes from baseline in Headache Frequency Score to 1 month and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 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'
|
Changes from baseline in Visual Analog Scale Score to 1 month and 3 months
|
Headache Impact Test-6 (HIT-6)
Time Frame: 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
|
Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months
|
Neck Disability Index (NDI)
Time Frame: 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.
|
Changes from baseline in Neck Disability Index Score to 1 month and 3 months
|
Pressure-Pain Threshold (PTT)
Time Frame: 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.
|
Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Mustafa Corum, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2020
Primary Completion (Actual)
September 10, 2020
Study Completion (Actual)
September 10, 2020
Study Registration Dates
First Submitted
September 6, 2020
First Submitted That Met QC Criteria
September 6, 2020
First Posted (Actual)
September 11, 2020
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 19, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/289
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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