Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain (CPS)
2013年11月5日 更新者：Florian Wepner、Orthopedic Hospital Vienna Speising
The Long-term Effect of an Outpatient Intervention Program With a Behavioral Therapy Approach in Patients With Chronic Back or Neck Pain With a Focus on Psychosocial Aspects
To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain.
Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.
調査の概要
詳細な説明
BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors.
OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.
DESIGN: Prospective, randomized controlled trial
SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.
MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.
研究の種類
介入
入学 (実際)
121
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
-
-
-
Vienna、オーストリア、1130
- Orthopedic Hospital Vienna Speising
-
-
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
18年～55年 (大人)
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:
- minimum age 18 years, maximum age: men 55 years, women 50 years.
- the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
- The patients had to be working at the start of the study.
Exclusion Criteria:
- Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
- Retired persons, those in the process of being screened for retirement, unemployed persons,
- pregnancy or persons on maternity leave
- Planned surgery during the phase of intervention
- persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Training group
Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.
|
Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.
Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs.
The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years).
After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.
|
|
介入なし：Control Group
Members of the control group were referred to their general practitioner or specialist for further care.
|
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 |
|---|---|---|
|
Pain
時間枠：After 0 / 6 / 58 Weeks
|
To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a visual analog scale (VAS; 0-100, lower scores indicate less severe pain)
|
After 0 / 6 / 58 Weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Social function, psychological wellbeing and emotional role function
時間枠：After 0 / 6 / 58 weeks
|
To evaluate social function, psychological wellbeing and emotional role function we used the 36-item short form health survey (SF-36; scales 0-100, lower scores indicate poorer social, psychological and emotional quality of life)
|
After 0 / 6 / 58 weeks
|
|
Functional impairment
時間枠：After 0 / 6 / 58 weeks
|
The Oswestry disability index was used to measure functional impairment.
|
After 0 / 6 / 58 weeks
|
|
Anxiety, insecurity in social contacts and compulsiveness
時間枠：After 0 / 6 / 58 weeks
|
Anxiety, insecurity in social contacts and compulsiveness were registered on the brief symptoms inventory (BSI), which is an abridged version of SCL-90_R.
The BSI addresses subjective experience of impairment based on a list of symptoms that are partly physical and partly psychological.
The time frame is seven days.
|
After 0 / 6 / 58 weeks
|
|
Sick leave days
時間枠：After 0 / 58 weeks
|
The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
|
After 0 / 58 weeks
|
|
Painkillers
時間枠：After 0 / 58 weeks
|
The number of painkillers taken per day were inquired.
|
After 0 / 58 weeks
|
|
Fear avoidance behavior
時間枠：After 0 / 6 / 58 weeks
|
Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)
|
After 0 / 6 / 58 weeks
|
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。
捜査官
- 主任研究者：Florian Wepner, Dr.、Orthopedic Hospital Vienna Speising
- スタディチェア：Martin Friedrich, Prof.、Orthopedic Hospital Vienna Speising
- スタディディレクター：Julia Hahne, Mag.、Orthopedic Hospital Vienna Speising
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Hides JA, Jull GA, Richardson CA. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine (Phila Pa 1976). 2001 Jun 1;26(11):E243-8. doi: 10.1097/00007632-200106010-00004.
- Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.
- Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.
- van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, van Tulder MW. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J. 2011 Jan;20(1):19-39. doi: 10.1007/s00586-010-1518-3. Epub 2010 Jul 18.
- Chou R, Loeser JD, Owens DK, Rosenquist RW, Atlas SJ, Baisden J, Carragee EJ, Grabois M, Murphy DR, Resnick DK, Stanos SP, Shaffer WO, Wall EM; American Pain Society Low Back Pain Guideline Panel. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). 2009 May 1;34(10):1066-77. doi: 10.1097/BRS.0b013e3181a1390d.
- Klenerman L, Slade PD, Stanley IM, Pennie B, Reilly JP, Atchison LE, Troup JD, Rose MJ. The prediction of chronicity in patients with an acute attack of low back pain in a general practice setting. Spine (Phila Pa 1976). 1995 Feb 15;20(4):478-84. doi: 10.1097/00007632-199502001-00012.
- Somerville S, Hay E, Lewis M, Barber J, van der Windt D, Hill J, Sowden G. Content and outcome of usual primary care for back pain: a systematic review. Br J Gen Pract. 2008 Nov;58(556):790-7, i-vi. doi: 10.3399/bjgp08X319909.
- Johnson RE, Jones GT, Wiles NJ, Chaddock C, Potter RG, Roberts C, Symmons DP, Watson PJ, Torgerson DJ, Macfarlane GJ. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007 Jul 1;32(15):1578-85. doi: 10.1097/BRS.0b013e318074f890.
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
2006年3月1日
一次修了 (実際)
2008年2月1日
研究の完了 (実際)
2008年2月1日
試験登録日
最初に提出
2013年8月29日
QC基準を満たした最初の提出物
2013年11月5日
最初の投稿 (見積もり)
2013年11月13日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年11月13日
QC基準を満たした最後の更新が送信されました
2013年11月5日
最終確認日
2013年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Praev123
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。
首の痛みの臨床試験
-
Dexa Medica Group完了
Physiotherapy and occupational therapyの臨床試験
-
Training and Implementation Associates募集従来の対面トレーニング | 家族療法のトレーニングと実装プラットフォーム (FTTIP)アメリカ