Exercise and Manipulative Therapy for Older Persons With Headache

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736774
• Other study ID #: MRG5580145
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: January 26, 2016
• Start date: December 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• Usual care intervention
The usual care intervention will include appropriate primary care as required including medication
• Physiotherapy treatment
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)

Locations

Country	Name	City	State
Thailand	Department of Physical Therapy, Faculty of Associated Medical Sciences	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency	The number of headache frequency in the past week	Change from baseline in headache frequency at week 11 and 6 months after intervention	No
Secondary	Headache intensity	An average intensity in the past week will be rated on a 1-10 VAS	Change from baseline in headache intensity at week 11 and 6 months after intervention	No
Secondary	Headache duration	The number of hours of headache in the past week	Change from baseline in headache duration at week 11 and 6 months after intervention	No
Secondary	Neck pain intensity	Intensity of neck pain will be measured using a 1-10 VAS	Change from baseline in neck pain intensity at week 11 and 6 months after intervention	No
Secondary	Neck pain and disability	Neck pain and disability will be measured using neck disability index (NDI-Thai version)	Change from baseline in neck pain and disability at week 11 and 6 months after intervention	No
Secondary	Quality of life	The Quality of life will be measured using SF-36 (Thai version)	Change from baseline in quality of life at week 11 and 6 months after intervention	No
Secondary	Medication intake	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	Change from baseline in medication intake at week 11 and 6 months after intervention	No
Secondary	Global assessment of treatment benefit	Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)	Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention	No