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Effectiveness of Manual Therapy vs Exercises With Foam Rolling for Tension Headache (MTvsFR-TTH)

Primary Purpose

Tension-type Headache

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy protocol
Foam Rolling protocol
Placebo control
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tension-type Headache focused on measuring Tension-type headache, Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Physiotherapy
  • Gemma V Espí López

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Manual therapy protocol

Foam Rolling protocol

Placebo Control

Arm Description

Treatment based on manual therapy with proven evidence.

Treatment based on massage with a Foam Rolling

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disability headache
Headache Disability Index (HDI). Questionnaire developed by G.P. Jacobson et al. to quantify the impact of disability due to headache in daily life. The objective is to identify the difficulties that the patient experiences due to headaches. It consists of two questions: 1) intensity of pain (mild, moderate and severe), and 2) frequency (once a month, more than 1 and less than 4 times a month, and once a week). In addition, it includes 25 items with two subscales, one emotional (13 items) and another functional (12 items) with three possible answers ("no" 0 points, "sometimes" 2 points, "yes" 4 points). The maximum score is 100 points, with 0 "no disability" and 100 "maximum disability".
Impact of headache
Headache Impact Test (HIT-6). Published by Ware et al. To measure the impact of headache. The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points). With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".
Pressure pain threshold
Algometer. To assess the pain threshold at the pressure of the different muscles, a mechanical pressure algometer (Wagner Instruments FDK 20) will be used. The pressure pain threshold is the minimum pressure that is needed to cause pain or discomfort at a certain point. In obtaining the result, the average of the 3 scores obtained from each point was made. The reliability of this procedure is high in healthy subjects [BCI = 0.91 (95% confidence interval: 0.82-0.97)] 28.31. In patients with TMD, reliability is moderate (ICC = 0.64)
Cervical range movment
Goniometry. The range of joint movement of the neck is measured by the use of a goniometer. Flexion, extension, lateral tilt and cervical rotation are assessed. To be able to perform the measurement, the patient is asked to remain in a sitting position keeping his back at 90 degrees and his head in a neutral position. The physiotherapist instructs the patients to perform the previously explained movements, until reaching the maximum range of movement or in the presence of pain. We proceed to evaluate mobility in the 3 planes: sagittal plane, frontal plane and transverse plane. 3 measurements of each movement are made, and the final measurement obtained is the average of each previous result.
Body satisfaction
Body satisfaction questionnaire. It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.
Health Status
SF-36 questionnaire. It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).

Full Information

First Posted
June 1, 2018
Last Updated
February 19, 2020
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03591601
Brief Title
Effectiveness of Manual Therapy vs Exercises With Foam Rolling for Tension Headache
Acronym
MTvsFR-TTH
Official Title
Effectiveness of a Global Manual Therapy Protocol vs Exercises With Foam Rolling for Tension Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Introduction Primary headaches occupy an important field in neurology consultations. Both migraines and tension headaches are often self-treated by the patients themselves and for some patients, headache is a true disease, constituting a symptomatology that can have various etiologies, from severe to functional organics. Headache, when it becomes chronic, becomes a serious problem for the patient with important repercussions on their quality of life. Objective. To evaluate the effectiveness of the application of the treatment by means of manual therapy in patients with tension headache and to compare it with the application of massage by means of a roll of foam manufactured for this purpose. Methodology The study will be carried out in the Faculty of Physiotherapy of the Universitat de València. An experimental, longitudinal and prospective design, controlled, randomized, with 3 groups will be carried out. Population. The sample will be formed by participants diagnosed with tension headache, following the criteria established by the IHS. Subjects with headache less than 15 days per month and other types of primary headache, as well as those associated with drug abuse and those who do not meet the criteria established by the IHS, will be excluded from the study. Experimental treatment The patients will be randomly assigned to 3 different groups (one group of treatment with manual therapy, one group that will receive massage and another group of placebo control). The treatment will last for 8 weeks (4 weeks of treatment and 4 weeks of follow-up). The 2 groups will be evaluated before treatment, at the end of this and in the follow-up (30 days after treatment). Evaluations For the collection of data, a clinical interview with data referring to headache was designed and the following evaluation instruments are included: Scale disability due to HDI Headache Impact of pain HIT-6 Quality of life SF-36 Visual Analog Scale (EVA) Algometry. Measurement of pain at pressure on spinous and transverse processes CROM. Cervical range QS. Body satisfaction questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
Keywords
Tension-type headache, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy protocol
Arm Type
Active Comparator
Arm Description
Treatment based on manual therapy with proven evidence.
Arm Title
Foam Rolling protocol
Arm Type
Experimental
Arm Description
Treatment based on massage with a Foam Rolling
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Placebo treatment based on the placement of the hands on the head without intention to treat.
Intervention Type
Other
Intervention Name(s)
Manual Therapy protocol
Intervention Description
Treatment based on manual therapy with proven evidence.
Intervention Type
Other
Intervention Name(s)
Foam Rolling protocol
Intervention Description
Treatment based on massage with a Foam Rolling
Intervention Type
Other
Intervention Name(s)
Placebo control
Intervention Description
Placebo treatment based on the placement of the hands on the head without intention to treat.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Disability headache
Description
Headache Disability Index (HDI). Questionnaire developed by G.P. Jacobson et al. to quantify the impact of disability due to headache in daily life. The objective is to identify the difficulties that the patient experiences due to headaches. It consists of two questions: 1) intensity of pain (mild, moderate and severe), and 2) frequency (once a month, more than 1 and less than 4 times a month, and once a week). In addition, it includes 25 items with two subscales, one emotional (13 items) and another functional (12 items) with three possible answers ("no" 0 points, "sometimes" 2 points, "yes" 4 points). The maximum score is 100 points, with 0 "no disability" and 100 "maximum disability".
Time Frame
8 weeks
Title
Impact of headache
Description
Headache Impact Test (HIT-6). Published by Ware et al. To measure the impact of headache. The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points). With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".
Time Frame
8 weeks
Title
Pressure pain threshold
Description
Algometer. To assess the pain threshold at the pressure of the different muscles, a mechanical pressure algometer (Wagner Instruments FDK 20) will be used. The pressure pain threshold is the minimum pressure that is needed to cause pain or discomfort at a certain point. In obtaining the result, the average of the 3 scores obtained from each point was made. The reliability of this procedure is high in healthy subjects [BCI = 0.91 (95% confidence interval: 0.82-0.97)] 28.31. In patients with TMD, reliability is moderate (ICC = 0.64)
Time Frame
8 weeks
Title
Cervical range movment
Description
Goniometry. The range of joint movement of the neck is measured by the use of a goniometer. Flexion, extension, lateral tilt and cervical rotation are assessed. To be able to perform the measurement, the patient is asked to remain in a sitting position keeping his back at 90 degrees and his head in a neutral position. The physiotherapist instructs the patients to perform the previously explained movements, until reaching the maximum range of movement or in the presence of pain. We proceed to evaluate mobility in the 3 planes: sagittal plane, frontal plane and transverse plane. 3 measurements of each movement are made, and the final measurement obtained is the average of each previous result.
Time Frame
8 weeks
Title
Body satisfaction
Description
Body satisfaction questionnaire. It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.
Time Frame
8 weeks
Title
Health Status
Description
SF-36 questionnaire. It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Gemma V Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Manual Therapy vs Exercises With Foam Rolling for Tension Headache

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