Manual Therapy in Tension-type Headache

NCT04546165 | Completed

• 1 other identifier: 2020/289
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analog Scale (VAS)

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

• Headache Impact Test-6 (HIT-6)

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

• Neck Disability Index (NDI)

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

• Pressure-Pain Threshold (PTT)

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

Study Arms (3)

manipulation group

ACTIVE COMPARATOR

manipulation plus exercise

Procedure: suboccipital inhibition plus exercise; Procedure: exercise

myofascial release group

ACTIVE COMPARATOR

suboccipital inhibition plus exercise

Procedure: manipulation plus exercise; Procedure: exercise

exercise group

ACTIVE COMPARATOR

only exercise

Procedure: manipulation plus exercise; Procedure: suboccipital inhibition plus exercise

Interventions

manipulation plus exercise PROCEDURE

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

exercise group; myofascial release group

suboccipital inhibition plus exercise PROCEDURE

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 group; manipulation group

exercise PROCEDURE

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).

manipulation group; myofascial release group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mustafa Corum, MD

  Istanbul Physical Medicine Rehabilitation Training & Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 11, 2020
• Study Start: June 22, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

TU (1)