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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025732

Enrollment

Registered

2021-06-30

Start date

2021-07-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G44.2

Interventions

Group 1: The intervention group receives three structured treatments over a period of one month. Each of the three treatment sessions takes place at regular intervals of one week and lasts approximat

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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): - Objectives and Guiding Questions for a Feasibility Study. - Calculation of the expected duration - Standardized recording scheme to detect adverse events - G*power analysis These will be completed and calculated by the study investigators only after the follow-up date.	—

Measure

Time frame

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): - Objectives and Guiding Questions for a Feasibility Study. - Calculation of the expected duration - Standardized recording scheme to detect adverse events - G*power analysis These will be completed and calculated by the study investigators only after the follow-up date.

—

Secondary

Measure	Time frame
Before the first treatment and after each of the three treatments, the subjects are asked about their state of health using the following questionnaires: - Numeric Rating Scale (NRS) - Short Form Health Survey (SF-36) - Headache Disability Inventory (HDI) In addition, the subjects' heart rate variability (HRV) is measured before and after each treatment. 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.	—

Measure

Time frame

Before the first treatment and after each of the three treatments, the subjects are asked about their state of health using the following questionnaires: - Numeric Rating Scale (NRS) - Short Form Health Survey (SF-36) - Headache Disability Inventory (HDI) In addition, the subjects' heart rate variability (HRV) is measured before and after each treatment. 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.

—

Countries

Germany

Contacts

Public ContactLucas Bohlen

Osteopathie Schule Deutschland

lbohlen@osteopathie-schule.de004917632200288

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026