Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?

NCT02450955 | Completed

• 1 other identifier: ID006
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective. To compare the benefits of spinal manipulation combined with massage therapy versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity and disability caused by headache and on cervical range of motion. Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the treatment group received a manipulative technique followed by massage of the cervical and suboccipital region; a) the control group received massage alone. Four sessions (once per week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to evaluate changes in the frequency and severity of headache and functional and emotional aspects of headache. Range of upper cervical and cervical flexion and extension were evaluated. Measures were conducted at baseline, immediately after the intervention (week 4) and at a follow up 8 weeks after completion of the intervention.

Conditions

Tension-type Headache

Keywords

Tension-type headache; manual therapy; disability; spinal manipulation

Outcome Measures

Primary Outcomes (1)

• Headache Disability Inventory (HDI).

  An inventory of disability caused by headaches developed by Jacobson et al. and Gary et al. was used. The purpose of the scale is to identify the difficulties the patient may experience due to headache. It includes 2 items: headache severity (mild, moderate and severe) and frequency (once a month, more than once and less than 4 times a month, and once a week) and 25 items that assess two subscales (E = Emotional with 13 items and F = Functional, with 12 items). Subjects answer each question (yes = 4 points, sometimes = 2 points or no = 0 points). The maximum disability score in this inventory is 100 points. The Spanish adaptation was performed by Rodríguez et al. in 2000, and provides a good index of internal consistency (Cronbach 0.94).

  8 weeks

Secondary Outcomes (1)

• Cervical range of motion

  8 weeks

Study Arms (2)

Massage

ACTIVE COMPARATOR

A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading.

Other: Massage

Occiput-Atlas-Axis Technique

EXPERIMENTAL

The technique is applied in two stages: in the first stage, a light core decompression is performed and then small circumductions are made with the aim of increasing viscoelasticity of tissues. Subsequently the appropriate joint barrier is sought by selective tension and high-velocity rotation manipulation is performed in a cranial helical motion without raising the subjects head.

Other: Occiput-Atlas-Axis Technique

Interventions

Massage OTHER

A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading, five minutes prone and five minutes supine with a focus on cervical and suboccipital muscles in order to induce a global relaxation of the cervical and suboccipital region. Resting position. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.

Also known as: Active Comparator

Massage

Occiput-Atlas-Axis Technique OTHER

This technique was applied as described previously and is used with the aim of restoring joint mobility between the occiput, atlas and axis. It is a structural technique applied bilaterally, performed on a vertical axis passing through the dens process of the axis without extension or flexion and very little side-bending. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.

Also known as: Experimental

Occiput-Atlas-Axis Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 18 and 65 years
• Diagnosis of frequent ETTH and CTTH
• Having headache episodes on more than 4 days per month
• Headache episodes lasting from 30 minutes to 7 days
• Headaches having at least 2 of the following characteristics:
• Bilateral location of pain
• Pressing non pulsating quality
• Mild or moderate intensity
• Not aggravated by physical activity
• Sufferers may present photophobia, phonophobia, nausea or vomiting
• Headache may be associated with pericranial tenderness
• Suffering from TTH for over 3 months
• Subjects being under pharmacological control

You may not qualify if:

• Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
• Headache that is aggravated by head movements.
• Metabolic or musculoskeletal disorders with symptoms similar to headache (rheumatoid arthritis)
• Previous neck trauma
• Vertigo, dizziness, arterial hypertension.
• Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
• Patients with heart devices
• Patients in process of pharmacological adaptation
• Excessive emotional tension
• Neurological disorders
• Laxity of neck soft tissues
• Radiological alterations
• General hypermobility or hyperlaxity
• Joint instability
• Pregnancy

Sponsors & Collaborators

• University of Valencia: lead

Related Publications (4)

• Victoria Espi-Lopez G, Arnal-Gomez A, Arbos-Berenguer T, Gonzalez AAL, Vicente-Herrero T. Effectiveness of Physical Therapy in Patients with Tension-type Headache: Literature Review. J Jpn Phys Ther Assoc. 2014;17(1):31-38. doi: 10.1298/jjpta.Vol17_005.

  PMID: 25792906 BACKGROUND

• Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.

  PMID: 25440210 BACKGROUND

• Espi-Lopez GV, Gomez-Conesa A. Efficacy of manual and manipulative therapy in the perception of pain and cervical motion in patients with tension-type headache: a randomized, controlled clinical trial. J Chiropr Med. 2014 Mar;13(1):4-13. doi: 10.1016/j.jcm.2014.01.004.

  PMID: 24711779 BACKGROUND

• 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.

  PMID: 24785463 RESULT

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Massage

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 21, 2015
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-05