Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

Healthcare Center Haarlemmermeer, Hoofddorp, the Netherlands.
BMC Musculoskeletal Disorders (Impact Factor: 1.9). 03/2009; 10:21. DOI: 10.1186/1471-2474-10-21
Source: PubMed

ABSTRACT Patients with Chronic Tension Type Headache (CTTH) report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being) and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles.We present the design of a randomised clinical trial (RCT) evaluating the effectiveness of manual therapy (MT) compared to usual care by the general practitioner (GP) in patients with CTTH.
Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS).Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques), exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks.
This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible.The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Study Design Prospective longitudinal study. Objective To explore the working mechanism of manual therapy, we investigated whether 3 cervical spine variables were mediators of the effect of manual therapy on headache frequency. Background Manual therapy has been shown to reduce headache frequency in participants with chronic tension-type headache (CTTH). To what extent specific elements of treatment contribute to the effectiveness of manual therapy in CTTH is unknown. Methods One hundred eighty-two participants with CTTH participated in a prospective longitudinal study: 142 underwent manual therapy and 40 participants received usual care by their general practitioner. Regression analysis was performed according to the steps described by Baron and Kenny, and the proportion of mediated effect was estimated for 3 potential mediators: (1) cervical range of motion, (2) neck flexor endurance, and (3) forward head posture. Outcome was defined as a 50% or greater reduction in headache days. Results Neck flexor endurance mediated 24.5% of the effect of manual therapy. Cervical range of motion and forward head posture showed no mediated effect. Conclusions Increased neck flexor endurance appears to be a working mechanism of manual therapy. This finding supports isometric training of neck flexors in participants with CTTH. Trial registered with Netherlands Trial Register (TR 1074). J Orthop Sports Phys Ther 2013;43(10):693-699. Epub 9 September 2013. doi:10.2519/jospt.2013.4868.
    Journal of Orthopaedic and Sports Physical Therapy 10/2013; 43(10):693-699. DOI:10.2519/jospt.2013.4868 · 2.38 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Tinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population. One subtype is cervicogenic somatic tinnitus, arising from cervical spine dysfunctions, justifying cervical spine assessment and treatment. This study aims to investigate the effect of a standardized physical therapy treatment, directed to the cervical spine, on tinnitus. Additionally, a second aim is to identify a subgroup within the tinnitus population that benefits from physical therapy treatment.Methods and design: This study is designed as a randomized controlled trial with delayed treatment design. Patients with severe subjective tinnitus (Tinnitus Functional Index (TFI) between 25 and 90 points), in combination with neck complaints (Neck Bournemouth Questionnaire (NBQ) >14 points) will be recruited from the University Hospital of Antwerp.Patients suffering from tinnitus with clear otological etiologies, severe depression, traumatic cervical spine injury, tumors, cervical spine surgery, or conditions in which physical therapy is contra-indicated, will be excluded.After screening for eligibility, baseline data such as TFI, NBQ, and a set of cervical biomechanical and sensorimotor tests will be collected.Patients are randomized in an immediate therapy group and in a group with a delayed start of therapy by 6 weeks.Patients will receive physical therapy with a maximum of 12 sessions of 30 min for a 6-week program. Data from the TFI and NBQ will be collected at baseline (week 0), at the start of therapy (weeks 0 or 6), at the end of therapy (weeks 6 or 12), 6 weeks after therapy (weeks 12 or 18), and 3 months after therapy (weeks 18 or 24). Secondary outcome measures will be collected at baseline and 6 weeks after the therapy (weeks 12 or 18), as the maximal therapy effect on the cervical spine dysfunctions is expected at that moment.
    Trials 07/2014; 15(1):297. DOI:10.1186/1745-6215-15-297 · 2.12 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: This systematic review updated and extended the "UK evidence report" by Bronfort et al. (Chiropr Osteopath 18:3, 2010) with respect to conditions / interventions that received an 'inconclusive' or 'negative' evidence rating or were not covered in the report. A literature search of more than 10 general medical and specialised databases was conducted in August 2011 and updated in March 2013. Systematic reviews, primary comparative studies and qualitative studies of patients with musculoskeletal or non-musculoskeletal conditions treated with manual therapy and reporting clinical outcomes were included. Study quality was assessed using standardised instruments, studies were summarised, and the results were compared against the evidence ratings of Bronfort. These were either confirmed, updated, or new categories not assessed by Bronfort were added. 25,539 records were found; 178 new and additional studies were identified, of which 72 were systematic reviews, 96 were RCTs, and 10 were non-randomised primary studies. Most 'inconclusive' or 'moderate' evidence ratings of the UK evidence report were confirmed. Evidence ratings changed in a positive direction from inconclusive to moderate evidence ratings in only three cases (manipulation / mobilisation [with exercise] for rotator cuff disorder; spinal mobilisation for cervicogenic headache; and mobilisation for miscellaneous headache). In addition, evidence was identified on a large number of non-musculoskeletal conditions not previously considered; most of this evidence was rated as inconclusive. Overall, there was limited high quality evidence for the effectiveness of manual therapy. Most reviewed evidence was of low to moderate quality and inconsistent due to substantial methodological and clinical diversity. Areas requiring further research are highlighted.
    03/2014; 22(1):12. DOI:10.1186/2045-709X-22-12

Full-text (2 Sources)

Available from
May 21, 2014