Manual Therapy in Tension-type Headache

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04546165
Collaborator
(none)
45
1
3
2.6
17.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: manipulation plus exercise
  • Procedure: suboccipital inhibition plus exercise
  • Procedure: exercise
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
Actual Study Start Date :
Jun 22, 2020
Actual Primary Completion Date :
Sep 10, 2020
Actual Study Completion Date :
Sep 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: manipulation group

manipulation plus exercise

Procedure: 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

Procedure: 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).

Active Comparator: myofascial release group

suboccipital inhibition plus exercise

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

Procedure: 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).

Active Comparator: exercise group

only exercise

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

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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'

  2. 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

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Istanbul Bahcelievler Turkey 34180

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Mustafa Corum, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa Corum, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04546165
Other Study ID Numbers:
  • 2020/289
First Posted:
Sep 11, 2020
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2020