Exercise and Manipulative Therapy for Older Persons With Headache
2016年1月26日 更新者:Sureeporn Uthaikhup、Chiang Mai University
A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
65
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chiang Mai、タイ
- Department of Physical Therapy, Faculty of Associated Medical Sciences
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年~75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Usual care intervention
Primary care as required including medication
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The usual care intervention will include appropriate primary care as required including medication
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実験的:Physiotherapy treatment
Exercise and manipulative therapy
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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)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache frequency
時間枠:Change from baseline in headache frequency at week 11 and 6 months after intervention
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The number of headache frequency in the past week
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Change from baseline in headache frequency at week 11 and 6 months after intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache intensity
時間枠:Change from baseline in headache intensity at week 11 and 6 months after intervention
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An average intensity in the past week will be rated on a 1-10 VAS
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Change from baseline in headache intensity at week 11 and 6 months after intervention
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Headache duration
時間枠:Change from baseline in headache duration at week 11 and 6 months after intervention
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The number of hours of headache in the past week
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Change from baseline in headache duration at week 11 and 6 months after intervention
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Neck pain intensity
時間枠:Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Intensity of neck pain will be measured using a 1-10 VAS
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Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Neck pain and disability
時間枠:Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Neck pain and disability will be measured using neck disability index (NDI-Thai version)
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Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Quality of life
時間枠:Change from baseline in quality of life at week 11 and 6 months after intervention
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The Quality of life will be measured using SF-36 (Thai version)
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Change from baseline in quality of life at week 11 and 6 months after intervention
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Medication intake
時間枠:Change from baseline in medication intake at week 11 and 6 months after intervention
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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
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Change from baseline in medication intake at week 11 and 6 months after intervention
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Global assessment of treatment benefit
時間枠:Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
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Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Sureeporn Uthaikhup, Ph.D.、Department of Physical Therapy, Faculty of Associated Medical Sciences
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年12月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2012年11月22日
QC基準を満たした最初の提出物
2012年11月26日
最初の投稿 (見積もり)
2012年11月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年1月28日
QC基準を満たした最後の更新が送信されました
2016年1月26日
最終確認日
2016年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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