Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?
Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?
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.
MATERIALS AND METHODS Participants The sample consisted of 105 people diagnosed with frequent
 (47.6%) and chronic (52.4%) TTH derived from two primary care centres, selected according to
 the criteria of IHS3,4, and suffering from headache for more than three months. Participants
 were aged between 18 and 65 years (mean ± SD: 38.9 ± 10.9 years), which included 23 men
 (21.9%) and 82 women (78.1%). Patients were excluded if they had suspected malignant disease,
 rheumatoid arthritis, pregnancy, vertigo, continuous intake of prescribed medication or those
 who received physical therapy in the past 3 months for headache or neck pain. Finally, 102
 subjects completed the study (2 from the treatment group dropped out due to work problems and
 one from the control due to lack of improvement).

 The software G*power14 was to calculate the required sample size, using data from previous
 studies to estimate the effect sizes to be expected. Our review of the extant literature
 showed that across studies, the mean N was 44.28 and in general large effect sizes were found
 (Cohen's d = .40).15-19 We accepted a 5% alpha risk (α = .05) and 10% beta risk (β = .1) as
 study parameters which showed that 51 subjects were required in each group to achieve a
 medium-to-large effect size (f = .35). We predicted a 5% dropout rate in the follow-up
 period.

 Study design The study was a factorial, randomized, double-blinded, placebo-controlled
 clinical trial. It was conducted from January to November, 2014. After the initial clinical
 interview, the allocation of patients to control or treatment groups was randomized by an
 external assistant using a specific software (name) who monitored the sequence and
 documentation at all times. Both the external assistant and the therapist and examiner were
 blinded to the study objective.

 Patients were randomly assigned into 2 groups (treatment and control). The treatment group
 received occiput-atlas-axis manipulation (OAA) and soft tissue treatment by massage. The
 control group received massage only. Thus both groups received the same duration of massage
 therapy and the exposure times were the same, however the difference between groups lay in
 the manipulative OAA technique which only the treatment group received. Four sessions were
 conducted (once per week) and the assessment was carried out in 3 stages: at baseline, end of
 treatment (at 4 weeks) and follow-up at 8 weeks following completion of treatment. All
 patients in both groups were assessed under the same conditions before and after the
 treatment by an examiner blinded to the group allocation.

 The study was conducted at the University of Valencia (Spain) from January 2014 to November
 2014. Prior to data collection, informed written consent was obtained from all patients, and
 all procedures were conducted according to the Declaration of Helsinki.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  • 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

 -  Received physical therapy treatment for headache or neck pain in the previous 3
 months

 -  Suspicion of malignancy