Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?
Condition: Tension-type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Massage; Occiput-Atlas-Axis Technique
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Other intervention name(s): Active Comparator; Experimental
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tension-type headache; manual therapy; disability; spinal manipulation