Clinical trial NCT02450955: Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?
Official title: Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients? A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-type Headache
Keywords: Tension-type headache
manual therapy
disability
spinal manipulation
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache Disability Inventory (HDI).
timeFrame: 8 weeks
Secondary outcomes:
measure: Cervical range of motion
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
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.