In April 2016 Manchester eScholar was replaced by the University of Manchester’s new Research Information Management System, Pure. In the autumn the University’s research outputs will be available to search and browse via a new Research Portal. Until then the University’s full publication record can be accessed via a temporary portal and the old eScholar content is available to search and browse via this archive.

Developing and Evaluating a Complex Intervention to Treat Chronic Orofacial Pain

Joanna Goldthorpe

[Thesis].University of Manchester;2012.

Access to files

Abstract

Abstract Introduction: Chronic orofacial pain (COFP) is distressing and disabling to sufferers and can be costly to patients, health services and society. Frequently, no underlying medical pathology can be found to account for the condition. Despite this, patients are treated according to a biomedical model, often by mechanistic and invasive procedures, which tend to be unsuccessful and not evidence based. Evidence suggests that cognitive behavioural therapy (CBT) based management may produce improved outcomes for patients. However, published studies can tell us little about which intervention components are effective, or recommend an optimum way for these components to be applied. Aim: To develop an evidence based intervention for the management of COFP that is feasible and acceptable to patients and practitioners. Method: The Medical Research Council’s guidelines for developing complex interventions were used as a framework for the research. Evidence from multiple sources was synthesised to produce the draft components of an intervention to manage COFP. An exploratory trial investigated preliminary outcomes, acceptability, feasibility and explored parameters for a full scale randomised control trial. Results: The intervention was acceptable to participants and could be feasibly implemented. No conclusions could be drawn relating to the effectiveness of the intervention. Participants were not affected at baseline for a number of outcomes, which implies that cut off points should be introduced into the inclusion and exclusion criteria of any future studies. Conclusion: The study produced an intervention which is acceptable and feasible to participants, however it is not known if it is effective. A number of recommendations are made for progression to a larger, definitive trial.

Bibliographic metadata

Type of resource:
Content type:
Type of thesis:
Author(s) list:
Degree type:
PhD
Publication date:
Total pages:
276
Table of contents:
List of ContentsAbstract 12Declaration 13Copyright statement 13Acknowledgements 14Dedication 14The author 14Introduction 15Chapter 1 Background 161.1 Chronic Orofacial Pain 161.2 Prevalence 161.3 Diagnosis and management 171.4 Impact of COFP 181.4.1 Quality of life 181.4.2 Cost 181.5 COFP as a medically unexplained symptom syndrome 191.6 Psychological models of MUS conditions 201.7 Somatisation 211.8 Catastrophising 211.9 Summary 221.10 Evidence for Cognitive Behavioural Therapy (CBT) 221.11 Evidence supporting CBT as a treatment for COFP 221.12 Possible mechanisms of a CBT based intervention for COFP 231.13 Common sense model 251.14 Theory of planned behaviour 261.15 Summary 262 Chapter 2 Developing and evaluating evidence based intervention to treat Chronic Orofacial Pain – structure of the study 282.1 Aims and objectives 282.1.1 Phase 1 (Development and piloting stage) 282.1.2 Phase 2 (Implementation and evaluation phase) 292.2 Developing and evaluating complex healthcare interventions 322.3 Structure of work within MRC guidance 352.4 Conclusion 363 Chapter 3 Methodology 373.1 Mixed Methods. 373.2 Pragmatic approach 373.3 Purpose and rationale 383.4 Applying mixed methods within this study 383.5 Conclusion 404 Chapter 4 Phase 1: Developing a complex intervention to treat COFP …………………………………………………………………………………….414.1 From evidence to intervention 414.2 Component analysis of existing interventions 444.2.1 Introduction 444.2.2 Component analysis of CBT interventions for COFP (study 1b) 454.2.2.1 Aim 454.2.2.2 Method 454.2.3 Results 454.2.3.1 Component analysis – variation in delivery 454.2.3.2 Therapeutic components 494.2.4 Conclusion 524.3 SWOT analysis of components 524.3.1 Introduction 524.3.2 Aim 534.3.3 Method 534.3.4 Results 534.3.5 Conclusion 584.4 Evidence synthesis 594.4.1 Process 604.4.1.1 Expert contributors 604.4.1.2 Focus 604.4.2 Findings 614.4.2.1 Systematic review 614.4.2.2 Dentists survey 614.4.2.3 Interviews with patients and practitioners 614.4.2.4 Key findings 614.4.3 Conclusion 644.5 Intervention Manual 644.5.1 Development of “Managing chronic orofacial pain”; a manual for guided self - help 644.5.2 Mapping the synthesis evidence to the manual “managing chronic widespread pain” 644.5.3 Adapting the intervention 674.6 User group consultation 684.6.1 Introduction 684.6.2 Aim and objectives 684.6.3 Method 684.6.4 Results 694.6.5 Conclusion 714.7 Phase 1 summary 715 Chapter 5 Phase 2: Exploratory trial 725.1 Introduction 725.2 Aims and objectives 725.3 Design 735.4 Inclusion criteria 735.5 Exclusion criteria 735.6 Recruitment 735.7 Intervention 765.7.1 Manual 765.7.2 Guidance 765.7.2.1 Training programme 765.7.2.2 Clinical supervision 765.8 Control – Usual care 775.9 Outcomes 785.10 Questionnaires 795.10.1 SF36 version 2 795.10.2 Manchester orofacial pain disability scale 805.10.3 Brief Pain Inventory (BPI) 805.10.4 Hospital Anxiety and Depression Scale (HADS) 815.10.5 The revised Illness Perception Questionnaire (IPQr) 815.10.6 Piloting 825.10.7 Baseline 825.10.8 Follow up 825.10.9 Administration 835.11 Sample 835.11.1 Examining effects in small samples 835.12 Randomisation 845.12.1 Sequence generation 845.12.2 Minimisation 845.12.3 Justification for using non random allocation 855.13 Allocation concealment 855.14 Blinding 865.15 Statistical Methods 875.15.1 Statistical Analysis 875.15.2 Missing data 875.15.3 Data checks 885.15.4 Analysis of measures of central tendency 885.16 Ethical Issues: Potential Burdens and risks to participants 885.16.1 Burdens 895.16.2 Risks 895.16.3 Informed consent 905.17 Results 905.17.1 Recruitment 905.17.2 Characteristics of the sample 935.18 Outcomes 945.18.1 Introduction 945.18.2 Distribution of data 955.18.2.1 Non-parametric tests 955.18.3 Descriptive data 955.19 Primary outcome 995.19.1 Physical functioning (SF35) 995.20 Secondary outcomes 995.20.1 Role physical (SF36) 995.20.2 Bodily pain (SF36) 995.20.3 General health (SF36) 1005.20.4 Vitality (SF36) 1005.20.5 Social functioning (SF36) 1005.20.6 Role emotional (SF36) 1005.20.7 Mental Health (SF36) 1005.20.8 Physical component (SF36) 1015.20.9 Mental component (SF36) 1015.20.10 Manchester Orofacial pain disability scale 1035.20.11 Pain severity (Brief pain inventory) 1055.20.12 Activity Interference (Brief Pain inventory) 1055.20.13 Timeline (IPQr) 1085.20.14 Consequences (IPQr) 1085.20.15 Personal control (IPQr) 1085.20.16 Treatment control (IPQr) 1085.20.17 Illness coherence. (IPQr) 1095.20.18 Timeline cyclical (IPQr) 1095.20.19 Emotional representation (IPQr) 1095.20.20 Anxiety subscale (HADS) 1115.20.21 Depression subscale (HADS) 1115.21 Missing data 1125.22 Discussion 1125.22.1 Effectiveness 1125.22.2 Primary outcome 1125.22.3 Secondary outcomes 1135.22.4 Overall direction of scores 1135.22.5 Baseline characteristics 1155.22.6 Baseline scores and direction of effect for outcome domains 1165.22.7 Missing data 1185.22.8 Strengths of the study 1185.22.9 Limitations of the study 1185.22.10 Summary 1195.23 Feasibility and intervention processes 1205.23.1 Feasibility 1205.23.2 Recruitment activity 1205.23.3 Attrition in the intervention group 1235.24 Intervention processes 1235.24.1 Implementation 1235.24.2 Participants’ treatment priorities 1255.24.3 Discussion 1266 Chapter 6 Acceptability: Qualitative Study 1276.1 Introduction 1276.2 Sampling 1286.3 Participants 1286.4 Interviews 1296.4.1 Interviewer considerations 1306.5 Analysis 1316.5.1 Qualitative description 1316.5.2 Thematic Analysis 1326.5.3 Selecting a method for analysis 1326.6 Process of analysis 1336.7 Reliability 1346.8 Validity 1346.8.1 Constant comparison 1356.8.2 Examination of deviant cases 1356.8.3 Triangulation 1356.8.4 Reflexivity 1356.9 Findings 1366.9.1 Views on delivery of “Managing COFP” 1366.9.1.1 Contact time 1366.9.1.2 Mode of delivery and setting (telephone and face to face) 1376.9.1.3 Facilitators 1386.10 Engagement with and processes of “Managing Chronic Orofacial Pain”………………………………………………………………………………….1396.10.1 Identification with “Managing Chronic Orofacial Pain (COFP)” 1426.10.1.1 Identifying with the treatment model. 1426.10.1.2 Identification with “people like me” 1446.10.2 Feeling believed and understood 1466.10.3 Obtaining a plausible explanation for symptoms 1486.10.4 Effort required 1506.10.5 Acceptance of having a chronic or long term condition 1516.10.6 Demonstrative positive feedback 1536.10.7 Identifying unhelpful patterns 1546.10.8 Control 1556.10.9 Distraction 1576.11 Intervention model 1596.12 Implications of findings 1616.13 Reflexive statement. 1646.14 Discussion 1666.14.1 Introduction 1666.14.2 Characteristics of the sample 1666.14.3 Components relating to implementation 1676.14.4 Facilitators 1686.14.5 Engagement with “Managing COFP” 1686.14.6 Feeling believed and understood 1696.14.7 Plausible explanations 1696.14.8 Accepting long term illness and self management 1716.14.9 Helpful processes and techniques 1726.14.10 Examination of deviant cases 1726.14.11 Strengths of this study 1736.14.12 Limitations of this study 1746.14.13 Conclusion 1747 Chapter 7 Overall discussion. 1767.1 Introduction 1767.2 Principal findings 1767.2.1 Phase 1 1767.2.2 Phase 2 1767.2.3 Support for findings 1777.3 Strengths of the study 1787.4 Limitations of the study 1787.4.1 Indication of effect 1797.5 Outcome measures 1797.6 Conclusion 1807.6.1 Recommendations for the intervention 1817.6.2 Recommendations for trial design 181
Abstract:
Abstract Introduction: Chronic orofacial pain (COFP) is distressing and disabling to sufferers and can be costly to patients, health services and society. Frequently, no underlying medical pathology can be found to account for the condition. Despite this, patients are treated according to a biomedical model, often by mechanistic and invasive procedures, which tend to be unsuccessful and not evidence based. Evidence suggests that cognitive behavioural therapy (CBT) based management may produce improved outcomes for patients. However, published studies can tell us little about which intervention components are effective, or recommend an optimum way for these components to be applied. Aim: To develop an evidence based intervention for the management of COFP that is feasible and acceptable to patients and practitioners. Method: The Medical Research Council’s guidelines for developing complex interventions were used as a framework for the research. Evidence from multiple sources was synthesised to produce the draft components of an intervention to manage COFP. An exploratory trial investigated preliminary outcomes, acceptability, feasibility and explored parameters for a full scale randomised control trial. Results: The intervention was acceptable to participants and could be feasibly implemented. No conclusions could be drawn relating to the effectiveness of the intervention. Participants were not affected at baseline for a number of outcomes, which implies that cut off points should be introduced into the inclusion and exclusion criteria of any future studies. Conclusion: The study produced an intervention which is acceptable and feasible to participants, however it is not known if it is effective. A number of recommendations are made for progression to a larger, definitive trial.
Thesis advisor(s):
Abbreviated title:
Managing COFP
Language:
eng

Institutional metadata

University researcher(s):

Record metadata

Manchester eScholar ID:
uk-ac-man-scw:181940
Created by:
Goldthorpe, Joanna
Created:
22nd November, 2012, 17:29:40
Last modified by:
Goldthorpe, Joanna
Last modified:
22nd November, 2012, 17:29:40

Can we help?

The library chat service will be available from 11am-3pm Monday to Friday (excluding Bank Holidays). You can also email your enquiry to us.