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Manual Therapy in Tension-type Headache

Primary Purpose

Tension-Type Headache

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

manipulation plus exercise

suboccipital inhibition plus exercise

exercise

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

manipulation group

myofascial release group

exercise group

Arm Description

manipulation plus exercise

suboccipital inhibition plus exercise

only exercise

Outcomes

Primary Outcome Measures

Headache Frequency (HF)

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

Secondary Outcome Measures

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'

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

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.

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.

Full Information

NCT ID

NCT04546165

First Posted

September 6, 2020

Last Updated

November 19, 2020

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04546165

Brief Title

Manual Therapy in Tension-type Headache

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

June 22, 2020 (Actual)

Primary Completion Date

September 10, 2020 (Actual)

Study Completion Date

September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tension-Type Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

manipulation group

Arm Type

Active Comparator

Arm Description

manipulation plus exercise

Arm Title

myofascial release group

Arm Type

Active Comparator

Arm Description

suboccipital inhibition plus exercise

Arm Title

exercise group

Arm Type

Active Comparator

Arm Description

only exercise

Intervention Type

Procedure

Intervention Name(s)

manipulation plus exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

suboccipital inhibition plus exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

exercise

Intervention Description

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).

Primary Outcome Measure Information:

Title

Headache Frequency (HF)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

Time Frame

Changes from baseline in Visual Analog Scale Score to 1 month and 3 months

Title

Headache Impact Test-6 (HIT-6)

Description

Time Frame

Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months

Title

Neck Disability Index (NDI)

Description

Time Frame

Changes from baseline in Neck Disability Index Score to 1 month and 3 months

Title

Pressure-Pain Threshold (PTT)

Description

Time Frame

Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa Corum, MD

Organizational Affiliation

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

City

Istanbul

State/Province

Bahcelievler

ZIP/Postal Code

34180

Country

Turkey

12. IPD Sharing Statement

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Manual Therapy in Tension-type Headache

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