Back to resultsThe Influence of Manual Therapy in the Quality of Life in Tension-Type Headache (MTheadacheQL)
Primary Purpose
Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suboccipital inhibitory
Spinal manipulative
Combined treatment
Control group.
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life focused on measuring Efficacy, Tension-type headache, Manual therapy
Eligibility Criteria
Inclusion Criteria:
- diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.
Exclusion Criteria:
- Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.
Sites / Locations
- Gemma v. Espí López
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Suboccipital inhibitory
Spinal Manipulative
Combined treatment
Control group
Arm Description
Suboccipital inhibitory pressure technique. According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues.
Suboccipital inhibitory pressure technique. This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility.
Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).
Outcomes
Primary Outcome Measures
frequency of pain
These included major aspects for TTH verification, including frequency of noted pain (less than 15 days monthly = ETTH; more than 15 days monthly = CTTH) response to the classification of the IHS.
severity of pain
These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.
Secondary Outcome Measures
quality of life
To assess the subject's quality of life, we applied the health status questionnaire SF-12v2 (Short Form 12 Health Survey) which has shown to be highly reliable. This questionnaire has been adapted to the Spanish context by Alonso et al. and Monteagudo et al.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455323
Brief Title
The Influence of Manual Therapy in the Quality of Life in Tension-Type Headache
Acronym
MTheadacheQL
Official Title
Influence of Spinal Manipulation and Suboccipipital Inhibition as a Complementary Therapy for Tension Headache in Quality of Life: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study
Detailed Description
Object: The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques.
Methods: The study design involved a factorial, randomized, double-blind, controlled study of 76 subjects. They were divided into 4 groups: suboccipital inhibitory pressure was applied to the first group; suboccipital spinal manipulation was applied to the second group; a combination of the two treatments was applied to the third group; and the fourth group was a control group. Quality of life was assessed using the SF-12 questionnaire (both overall and in its different dimensions) at the beginning and at the end of treatment, and after one month as a follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
Efficacy, Tension-type headache, Manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suboccipital inhibitory
Arm Type
Experimental
Arm Description
Suboccipital inhibitory pressure technique. According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues.
Arm Title
Spinal Manipulative
Arm Type
Experimental
Arm Description
Suboccipital inhibitory pressure technique. This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility.
Arm Title
Combined treatment
Arm Type
Experimental
Arm Description
Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).
Intervention Type
Other
Intervention Name(s)
Suboccipital inhibitory
Intervention Description
According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. The aim is to suppress spasm of the muscles and in general of the suboccipital soft tissues which are responsible for any dysfunctional mobility of the occiput, atlas, or even the axis.
Intervention Type
Other
Intervention Name(s)
Spinal manipulative
Intervention Description
This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility
Intervention Type
Other
Intervention Name(s)
Combined treatment
Intervention Description
Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
Intervention Type
Other
Intervention Name(s)
Control group.
Intervention Description
The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).
Primary Outcome Measure Information:
Title
frequency of pain
Description
These included major aspects for TTH verification, including frequency of noted pain (less than 15 days monthly = ETTH; more than 15 days monthly = CTTH) response to the classification of the IHS.
Time Frame
one month prior to the study
Title
severity of pain
Description
These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.
Time Frame
one month prior to the study
Secondary Outcome Measure Information:
Title
quality of life
Description
To assess the subject's quality of life, we applied the health status questionnaire SF-12v2 (Short Form 12 Health Survey) which has shown to be highly reliable. This questionnaire has been adapted to the Spanish context by Alonso et al. and Monteagudo et al.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.
Exclusion Criteria:
Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma V Espí-López, PhD
Organizational Affiliation
Department of Physiotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Gemma v. Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17277641
Citation
Couppe C, Torelli P, Fuglsang-Frederiksen A, Andersen KV, Jensen R. Myofascial trigger points are very prevalent in patients with chronic tension-type headache: a double-blinded controlled study. Clin J Pain. 2007 Jan;23(1):23-7. doi: 10.1097/01.ajp.0000210946.34676.7d.
Results Reference
background
PubMed Identifier
19748404
Citation
Toro-Velasco C, Arroyo-Morales M, Fernandez-de-Las-Penas C, Cleland JA, Barrero-Hernandez FJ. Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study. J Manipulative Physiol Ther. 2009 Sep;32(7):527-35. doi: 10.1016/j.jmpt.2009.08.011.
Results Reference
background
PubMed Identifier
24785463
Citation
Espi-Lopez GV, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Benitez-Martinez JC, Lluch E, Falla D. Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial. Eur J Phys Rehabil Med. 2014 Dec;50(6):641-7. Epub 2014 Apr 30.
Results Reference
background
Learn more about this trial
The Influence of Manual Therapy in the Quality of Life in Tension-Type Headache
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