Osteopathic Treatment Approach to Chronic Tension–Type Headache by Means of Bifocal Integration: A Pilot and Feasibility Study

Not Applicable

Recruiting

Conditions: G44.2
Tension-type headache

Registration Number: DRKS00025732

Lead Sponsor: Osteopathie Schule Deutschland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Between 18-65 years old
Chronic tension type headache
Pain quality oppressive or restrictive non-pulsating, low to moderate pain intensity
for at least three months

Exclusion Criteria

Mental illnesses
Insufficient language skills
Systemic diseases (such as diabetes), heart diseases or metabolic diseases
Severe orthopedic diseases
Past operations on the skull or neck
Existing pregnancy
Receipt of any treatment in the past two weeks (medication and osteopathic or physical therapy should be suspended for the duration of the study; use of pain medication will be noted)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Since this is a pilot study, the following questionnaires and calculations will be used to determine feasibility, duration, potential side effects, and optimal number of participants for a future randomized controlled trial (RCT): <br>- Objectives and Guiding Questions for a Feasibility Study.<br>- Calculation of the expected duration<br>- Standardized recording scheme to detect adverse events<br>- G*power analysis<br>These will be completed and calculated by the study investigators only after the follow-up date.

Secondary Outcome Measures

Name	Time	Method
Before the first treatment and after each of the three treatments, the subjects are asked about their state of health using the following questionnaires: <br>- Numeric Rating Scale (NRS)<br>- Short Form Health Survey (SF-36)<br>- Headache Disability Inventory (HDI)<br>In addition, the subjects' heart rate variability (HRV) is measured before and after each treatment. <br>One month after the last treatment, the subjects are invited again for a follow-up appointment. They will be interviewed again using the questionnaires and HRV will be measured.