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Completed

NCT Number: NCT01736774

Exercise and Manipulative Therapy for Older Persons With Headache

The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache but other various frequent intermittent headache types (i.e. migraine and tension-type headache) in the elderly population. There has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment. Thus, the purpose of study investigate the efficacy of physiotherapy treatment for older persons who have headache concomitant with neck pain and musculoskeletal impairment

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, Thailand

About this study

Headache is a common health problem that affects quality of life in an older population and imposes substantial economic costs. Headache changes with age. Features of headache become less typical and neck pain is more frequently associated with headache in older persons. We recently demonstrated that the presence of cervical musculoskeletal impairment is not specific to cervicogenic headache (headache caused by the neck). Rather it was present in various frequent intermittent headache types in elders when compared to elders without headache. Changes in headache characteristics with age play an important role not only in diagnosis but also in treatment choice. Impairment in cervical musculoskeletal function found in older persons with headache has implications for headache management choices as the evidence indicates that physiotherapy management methods such as manual therapy and therapeutic exercise are an effective management approach for headache associated with the neck. Physiotherapy treatment would be a safe therapeutic option and may have a beneficial effect for elders with headache who have neck pain and concomitant cervical musculoskeletal dysfunction. This is particularly relevant as there are widespread concerns about medication overuse, adverse drug events and drug interactions in older persons. The effective management of older persons with headache in particular of those with atypical features of headache remains a challenge. Physiotherapy is indicated in those older persons diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headache. At present, there has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment. A clinical trial of treatment of cervical musculoskeletal impairment in older persons with various headache types may help guide management of headache in attempts to lesson medication use and cost in this population. Physiotherapy management may be a worthy treatment option particularly in older persons with headache who do not respond well to medication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers suffering from frequent intermittent headache (either migraine, tension-type headache or cervicogenic headache) at least one per month over a period of 3 months or longer
  • Aged 50 years or older, female or male
  • A score of ≥ 3/10 on visual analogue scale (VAS) of neck pain
  • Evidence of cervical musculoskeletal impairment: restriction in active range of cervical motion in extension and rotation and join tenderness in at least one of the upper joint as detected by manual palpation

Exclusion criteria

  • Headache diagnosed as following: temporal arteritis, trigeminal neuralgia, cluster headache, chronic paroxysmal hemicrania/hemicranias continua, temporomandibular joint dysfunction
  • Other diagnosed disorders: cerebrovascular disease, Parkinson disease, cognitive disturbance
  • Previous history of head or neck surgery
  • Lack of willingness to receive either pragmatic treatment or usual care
  • Physiotherapy or chiropractic treatment for headache in previous 6 months

Treatment and study plan

Usual Care intervention

Other

The usual care intervention will include appropriate primary care as required including medication

Physiotherapy Treatment

Other

Exercise and manipulative therapy treatment for 10 weeks:The treatment intervention consists of two visits per week for the first four weeks (8 treatments) and one visit per week for the last six weeks (6 treatments)

Primary outcomes

  1. Headache frequency

    Time frame: Change from baseline in headache frequency at week 11 and 6 months after intervention

    The number of headache frequency in the past week

Secondary outcomes

  1. Headache intensity

    Time frame: Change from baseline in headache intensity at week 11 and 6 months after intervention

    An average intensity in the past week will be rated on a 1-10 VAS

  2. Headache duration

    Time frame: Change from baseline in headache duration at week 11 and 6 months after intervention

    The number of hours of headache in the past week

  3. Neck pain intensity

    Time frame: Change from baseline in neck pain intensity at week 11 and 6 months after intervention

    Intensity of neck pain will be measured using a 1-10 VAS

  4. Neck pain and disability

    Time frame: Change from baseline in neck pain and disability at week 11 and 6 months after intervention

    Neck pain and disability will be measured using neck disability index (NDI-Thai version)

  5. Quality of life

    Time frame: Change from baseline in quality of life at week 11 and 6 months after intervention

    The Quality of life will be measured using SF-36 (Thai version)

  6. Medication intake

    Time frame: Change from baseline in medication intake at week 11 and 6 months after intervention

    type and dose of all medications taken by subjects will be recorded one week at baseline and prior to follow-up points on a medication diary

  7. Global assessment of treatment benefit

    Time frame: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention

    Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 29, 2012
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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