NCT03591601

Brief Summary

Tension headache (CT) is the most frequent problem within the group of headaches, with a prevalence of 30-78% of the population throughout its life. Regarding this pathology, treatment with manual therapy has been studied a lot, observing the benefits of different techniques separately in elements such as disability, impact or depression. The "Foam Rolling" (FR) is an element widely used in sport that has been studied its applications in terms of hip and knee flexibility after application in muscles such as the quadriceps or hamstrings. In this study the investigators recruited randomized subjects in three groups, one of exercises with RF, another of a protocol of manual therapy (TM) techniques and one control (CTR) with a placebo treatment. There will be 4 treatments, 1 per week, and the data will be collected in 3 moments, pre-treatment, post-treatment and one month after treatment. The investigators will evaluate aspects such as the average pain of headaches, the impact, disability, quality of life, self-satisfaction and pain at the pressure of painful points of the trapezius and suboccipital muscles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

June 1, 2018

Last Update Submit

February 19, 2020

Conditions

Tension-type Headache

Keywords

Tension-type headachePain

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Visual Analog Scale. The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

    8 weeks

Secondary Outcomes (6)

  • Disability headache

    8 weeks

  • Impact of headache

    8 weeks

  • Pressure pain threshold

    8 weeks

  • Cervical range movment

    8 weeks

  • Body satisfaction

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

Manual therapy protocol

ACTIVE COMPARATOR

Treatment based on manual therapy with proven evidence.

Other: Manual Therapy protocol

Foam Rolling protocol

EXPERIMENTAL

Treatment based on massage with a Foam Rolling

Other: Foam Rolling protocol

Placebo Control

PLACEBO COMPARATOR

Placebo treatment based on the placement of the hands on the head without intention to treat.

Other: Placebo control

Interventions

Manual Therapy protocolOTHER

Treatment based on manual therapy with proven evidence.

Manual therapy protocol
Foam Rolling protocolOTHER

Treatment based on massage with a Foam Rolling

Foam Rolling protocol
Placebo controlOTHER

Placebo treatment based on the placement of the hands on the head without intention to treat.

Placebo Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between 20 and 55 years old.
  • CT medical diagnosis.
  • Evolution of, at least, 3 months of the CT.
  • Suffer, at least, 1 crisis a week.
  • Meet, at least, 2 of the following IHS criteria:
  • Bilateral location.
  • Pressure pain, not pulsating pain.
  • Having a mild-moderate pain intensity.
  • Pain that is not aggravated by physical activity.
  • Minimum duration of 30 'of the TC.
  • Accompanied by some associated symptom:
  • or Photophobia. or Fonofobia. or mild nausea.

You may not qualify if:

  • Have less than 20 years or more than 55.
  • Cervical trauma.
  • Musculoskeletal problems that may be aggravated by movement.
  • Klein test positive.
  • Contraindications to receive manual therapy.
  • Musculoskeletal problems that may give another type of headache.
  • Problems of dizziness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

Gemma V Espí López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Tension-Type HeadachePain

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 19, 2018

Study Start

August 15, 2018

Primary Completion

November 15, 2018

Study Completion

December 15, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

ES(2)