Exercise and Manipulative Therapy for Older Persons With Headache

NCT ID: NCT01736774

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care intervention

Primary care as required including medication

Group Type: EXPERIMENTAL

Usual care intervention

Intervention Type: OTHER

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

Physiotherapy treatment

Exercise and manipulative therapy

Group Type: EXPERIMENTAL

Physiotherapy treatment

Intervention Type: 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)

Interventions

Usual care intervention

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Sureeporn Uthaikhup

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sureeporn Uthaikhup, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, Faculty of Associated Medical Sciences

Locations

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, , Thailand

Countries

Thailand

Other Identifiers

MRG5580145

Identifier Type: -

Identifier Source: org_study_id