Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain (CPS)
5 novembre 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
121
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Vienna, L'Autriche, 1130
- Orthopedic Hospital Vienna Speising
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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.
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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.
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Aucune intervention: Control Group
Members of the control group were referred to their general practitioner or specialist for further care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain
Délai: After 0 / 6 / 58 Weeks
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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)
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After 0 / 6 / 58 Weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Social function, psychological wellbeing and emotional role function
Délai: After 0 / 6 / 58 weeks
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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)
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After 0 / 6 / 58 weeks
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Functional impairment
Délai: After 0 / 6 / 58 weeks
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The Oswestry disability index was used to measure functional impairment.
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After 0 / 6 / 58 weeks
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Anxiety, insecurity in social contacts and compulsiveness
Délai: After 0 / 6 / 58 weeks
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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.
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After 0 / 6 / 58 weeks
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Sick leave days
Délai: After 0 / 58 weeks
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The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
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After 0 / 58 weeks
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Painkillers
Délai: After 0 / 58 weeks
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The number of painkillers taken per day were inquired.
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After 0 / 58 weeks
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Fear avoidance behavior
Délai: After 0 / 6 / 58 weeks
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Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)
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After 0 / 6 / 58 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Florian Wepner, Dr., Orthopedic Hospital Vienna Speising
- Chaise d'étude: Martin Friedrich, Prof., Orthopedic Hospital Vienna Speising
- Directeur d'études: Julia Hahne, Mag., Orthopedic Hospital Vienna Speising
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2006
Achèvement primaire (Réel)
1 février 2008
Achèvement de l'étude (Réel)
1 février 2008
Dates d'inscription aux études
Première soumission
29 août 2013
Première soumission répondant aux critères de contrôle qualité
5 novembre 2013
Première publication (Estimation)
13 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
13 novembre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 novembre 2013
Dernière vérification
1 novembre 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Praev123
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