Clinical trial NCT01736774: Exercise and Manipulative Therapy for Older Persons With Headache
Official title: A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Keywords: Manual therapy
Exercise
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache frequency
timeFrame: Change from baseline in headache frequency at week 11 and 6 months after intervention
Secondary outcomes:
measure: Headache intensity
timeFrame: Change from baseline in headache intensity at week 11 and 6 months after intervention
measure: Headache duration
timeFrame: Change from baseline in headache duration at week 11 and 6 months after intervention
measure: Neck pain intensity
timeFrame: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
measure: Neck pain and disability
timeFrame: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
measure: Quality of life
timeFrame: Change from baseline in quality of life at week 11 and 6 months after intervention
measure: Medication intake
timeFrame: Change from baseline in medication intake at week 11 and 6 months after intervention
measure: Global assessment of treatment benefit
timeFrame: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Physical Therapy, Faculty of Associated Medical Sciences
Study officials:
affiliation: Department of Physical Therapy, Faculty of Associated Medical Sciences
name: Sureeporn Uthaikhup, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: