Completed Research

Trial Name

Chief Investigator​




ACuTe FLAREs and flare phenotypes in knee osteoarthritis: an observational case-crossover study to improve recognition and advice for prevention and management
Professor George Peat

Acute Flares of Knee Osteoarthritis (the ACT-FLARE Study): Protocol for a Web-Based Case-Crossover Study in Community-Dwelling Adults: Martin J Thomas1,2, PhD; Trishna Rathod-Mistry1,3, MSc; Stephen Harper3, BSc; Emma L Parry1, MRCGP; Christopher Pope1, PhD; Tuhina Neogi4, MD, PhD; George Peat1, PhD. JMIR Res Protoc 2019 | vol. 8 | iss. 4 | e13428. 

Acute Flares of Knee Osteoarthritis (the ACT-FLARE Study): Protocol for a Web-Based Case-Crossover Study in Community-Dwelling Adults. Thomas MJ1, Rathod-Mistry T1, Harper S2, Parry EL1, Pope C1, Neogi T3, Peat G1: JMIR Research Protocols, 22 Apr 2019, 8(4):e13428


Professor Elaine Hay

Hay, E., Barlas, P., Foster, N., Hill, J., Thomas, E., & Young, J. Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?: the "acupuncture, physiotherapy and exercise" (APEX) study [ISRCTN88597683]. BMC Musculoskeletal Disorders 2004;5:31. doi: 10.1186/1471-2474-5-31

Foster, N. E., Thomas, E., Barlas, P., Hill, J. C., Young, J., Mason, E., & Hay, E. M. Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial. BMJ 2007:335(7617): 436-440. doi: 10.1136/bmj.39280.509803.BE.

Whitehurst, D. G., Bryan, S., Hay, E. M., Thomas, E., Young, J., & Foster, N. E. Cost-effectiveness of acupuncture care as an adjunct to exercise-based physical therapy for osteoarthritis of the knee. Physical Therapy 2011;91(5):630-641. doi: 10.2522/ptj.20100239

Foster, N. E., Thomas, E., Hill, J. C., & Hay, E. M. The relationship between patient and practitioner expectations and preferences and clinical outcomes in a trial of exercise and acupuncture for knee osteoarthritis. European Journal of Pain 2010;14(4):402-409. doi: 10.1016/j.ejpain.2009.06.010

MacPherson H, Maschino AC, Lewith G, Foster NE, Witt C, Vickers AJ on behalf of the Acupuncture Trialists’ Collaboration (2013). Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials. PLoS One, Oct 11;8(10):e77438. doi: 10.1371/journal.pone.0077438.

Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; for the Acupuncture Trialists' Collaboration (2012). Acupuncture for chronic pain: individual patient data meta-analysis. Archives of Internal Medicine 172(19):1444-53. doi:10.1001/archinternmed.2012.3654

Trial Name

Chief Investigator​



Professor Nadine Foster

Professor Kate Dunn

Foster, N.E., Bishop, A., Thomas, E., Main, C., Horne, R., Weinman, J., Hay, E. (2008) Illness perceptions of low back pain patients in primary care: What are they, do they change and are they associated with outcome? Pain, 136: 177-187

Foster, N.E., Thomas, E., Bishop, A., Dunn, K., Main, C. (2010) Distinctiveness of psychological obstacles to recovery in low back pain patients in primary care. Pain 148, 3, pp. 398-406

Grotle M, Foster NE, Dunn KM, Croft P (2010) Are prognostic indicators for poor outcome different for acute and chronic low back pain consulters in primary care? Pain, 151(3), pp. 790-7. Epub 2010 Oct 6.

Campbell P, Foster NE, Thomas E, Dunn KM (2013). Prognostic indicators of low back pain in primary care: Five year prospective study. The Journal of Pain, Aug;14(8):873-83. doi: 10.1016/j.jpain.2013.03.013. Epub 2013 Jun 20.

Campbell P, Bishop A, Dunn KM, Main CJ, Thomas E, Foster NE (2013). Conceptual overlap of psychological constructs in low back pain. Pain Sep;154(9):1783-91. doi: 10.1016/j.pain.2013.05.035. Epub 2013 May 29.
BEEP – Benefits of Exercise for Knee Pain

Professor Nadine Foster

Professor Elaine Hay

Foster, N. E., Healey, E. L., Holden, M. A., Nicholls, E., Whitehurst, D. G., Jowett, S., Jinks, C., Roddy, E., & Hay, E. M. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563). BMC Musculoskeletal Disorders 2014;15: 254. doi: 10.1186/1471-2474-15-254

BISTRO – BioImpedance To Maintain Renal Output Trial 

Professor Simon Davies 


Professor George Peat

Myers H, Nicholls E, Handy J, Peat G, Thomas E, Duncan R, et al. The Clinical Assessment Study of the Hand (CAS-HA): a prospective study of musculoskeletal hand problems in the general population. BMC Musculoskelet Disord 2007;8:85. 



Dr Edward Roddy  


Professor George Peat Peat G, Thomas E, Handy J, Wood L, Dziedzic K, Myers H, Wilkie R, Duncan R, Hay E, Hill J, Croft P. (2004) The Knee Clinical Assessment Study - CAS(K). A prospective study of knee pain and knee osteoarthritis in the general population, BMC Musculoskeletal Disorders, 5(4). 

CONTACT – Colchicine Or Naproxen Treatment for Acute gout

Dr Edward Roddy

McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database Syst Rev. 2021 Aug 26;8:CD006190. doi: 10.1002/14651858.CD006190.pub3. Review.

Roddy E, Clarkson K, Blagojevic-Bucknall M, Mehta R, Oppong R, Avery A, Hay EM, Heneghan C, Hartshorne L, Hooper J, Hughes G, Jowett S, Lewis M, Little P, McCartney K, Mahtani KR, Nunan D, Santer M, Williams S, Mallen CD. Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Ann Rheum Dis. 2020 Feb;79(2):276-284. doi: 10.1136/annrheumdis-2019-216154. Epub 2019 Oct 30.

Trial Name

Chief Investigator​


Diabetes & Depression Professor Athula Sumathipala  
EASEBACK – Evaluating Acupuncture and Standard care for pregnant women with BACK pain Professor Nadine Foster

Bishop ,A., Ogollah, R.O., Bartlam, B., Barlas, P., Holden, M.A., Ismail, K.M., Jowett, S., Lewis, A.M., Lloyd, A., Kettle, C., Kigozi, J., Foster, N.E., and the EASE Back study team. Evaluating acupuncture and Standard care for pregnant womEn with BACK pain: The EASE Back pilot radomised controlled trial (ISRCTN49955124). Pilot and Feasibility Studies (2016) 2:72 DOI10.1186/s40814-016-0107-6

Bartlam ,B., Waterfield, J., Bishop, A., Holden, M.A., Barlas, P., Ismail, K.M., Kettle, C., Foster, N.E. The role of qualitative research in clinical trial development: the EASE Back study. Journal of Mixed Methods Research 2016; Published online before print July doi: 10.1177/1558689816656740 .

Bishop ,A., Holden, M.A., Ogollah, R.O., Foster, N.E. Current management of pregnancy-related low back pain: A cross-sectional survey of the UK physiotherapists. Physiotherapy 2016; 102:78-85.

Foster, N.R., Bishop, A., Bartlam, B., Ogollah, R., Barlas, P., Holden, M.A., et al. Evaluating accupuncture and standard care for pregnant women with back pain (EASE Back): a feasibility study and pilot radomised trial. Health Technology Assessment 2016 Vol. 20: No. 33 DOI

Waterfield, J., Bartlam, B., Bishop, A., Holden, M.A., Barlas, P., Foster, NE., Physical therapists' views and experiences of pregnancy-related low back pain and the role of accupuncture: a qualitative exploration. Physical Therapy 2014 Apr 30. [Epub ahead of print]
ENHANCE – Improving care for people with long term conditions Professor Christian Mallen

Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial

Emma L Healey 1, Clare Jinks 1, Valerie A Tan 1, Carolyn A Chew-Graham, Sarah A Lawton 1, Elaine Nicholls 1, Andrew G Finney, Mark Porcheret 1, Vince Cooper 1, Martyn Lewis 1, Krysia S Dziedzic 1, Simon Wathall 1, Christian D Mallen 1. Journal of Comorbidity, Volume: 5 issue: 1, page(s): 135-149

Article first published online: December 18, 2015; Issue published: January 1, 2015. 

Trial Name

Chief Investigator


GOLF (2YR, 3YR, 4YR, 5YR)    
HIT – Improving Ooutcomes for Patients with Hip Osteoarthritis:
Hip Injection Trial
Dr Edward Roddy

A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol

Zoe Paskins 1 2, Gemma Hughes 3, Helen Myers 3, Emily Hughes 3, Susie Hennings 3, Andrea Cherrington 3, Amy Evans 4, Melanie Holden 4, Kay Stevenson 4 5, Ajit Menon 5, Kieran Bromley 4 3, Philip Roberts 6, Alison Hall 4, George Peat 4, Clare Jinks 4, Raymond Oppong 4 7, Martyn Lewis 4 3, Nadine E Foster 4 3, Christian Mallen 4, Edward Roddy 4 5 3. 

Trial Name

Chief Investigator


IMPACTBACK Professor Elaine Hay

Foster, N. E., Mullis, R., Young, J., Doyle, C., Lewis, M., Whitehurst, D., & Hay, E. M. IMPaCT Back study protocol. Implementation of subgrouping for targeted treatment systems for low back pain patients in primary care: a prospective population-based sequential comparison. BMC Musculoskeletal Disorders 2010;11: 186. doi: 10.1186/1471-2474-11-186

Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, Konstantinou K, Main C, Somerville S, Sowden G, Wathall S, Young J, Hay EM; IMPaCT Back Study team. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014 Mar-Apr;12(2):102-11. doi: 10.1370/afm.1625.

Sowden, G., Hill, J. C., Konstantinou, K., Khanna, M., Main, C. J., Salmon, P., Somerville, S., Wathall, S., & Foster, N. E. Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281). Family Practice 2012;29(1): 50-62. doi: 10.1093/fampra/cmr037
INCLUDE – INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community Professor Carolyn Chew-Graham

The INCLUDE study: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community; identifying multimorbidity: Protocol for a pilot randomized controlled trial

Samantha L Hider 1 2, Milica Bucknall 1 3, Kelly Cooke 2, Kendra Cooke 3, Andrew G Finney 1 4 5, Dave Goddin 3, Emma L Healey 1 6, Susie Hennings 3, Daniel Herron 1, Clare Jinks 1 6, Martyn Lewis 1 3, Annabelle Machin 1, Christian Mallen 1 6, Simon Wathall 1, Carolyn A Chew-Graham 1 6.

A pilot study of a nurse-led integrated care review (the INCLUDE review) for people with inflammatory rheumatological conditions in primary care: feasibility study findings

Samantha L Hider 1 2, Milica Bucknall 3 4, Clare Jinks 3 5, Kelly Cooke 6, Kendra Cooke 4, Erandie Ediriweera Desilva 3 7, Andrew G Finney 3 8, Emma L Healey 3, Daniel Herron 3, Annabelle R Machin 3, Christian D Mallen 3 5 9, Simon Wathall 3, Carolyn A Chew-Graham 3 5 9.

INSTinCTS – INjection versus SplinTing in Carpel Tunnel Syndrome Professor Elaine Hay

Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.

Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415.


Trial Name

Chief Investigator


MIR (Lead CTU: Bristol) – MIRtazapine added to Selective Serotinin Reuptake Inhibitors (SSRIs) for Treatment Resistant Depression in Primary Care: a placebo controlled randomised controlled trial Dr David Kessler (Bristol)

Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): study protocol for a randomised controlled trial

Debbie Tallon 1, Nicola Wiles 2, John Campbell 3, Carolyn Chew-Graham 4, Chris Dickens 5, Una Macleod 6, Tim J Peters 7, Glyn Lewis 8, Ian M Anderson 9, Simon Gilbody 10, William Hollingworth 11, Simon Davies 12, David Kessler 2. 

Mirtazapine added to SSRIs or SNRIs for treatment resistant depression in primary care: phase III randomised placebo controlled trial (MIR)

David S Kessler 1, Stephanie J MacNeill 2, Deborah Tallon 3, Glyn Lewis 4, Tim J Peters 3, William Hollingworth 3, Jeff Round 3, Alison Burns 3, Carolyn A Chew-Graham 5, Ian M Anderson 6, Tom Shepherd 5, John Campbell 7, Chris M Dickens 7, Mary Carter 7, Caroline Jenkinson 7, Una Macleod 8, Helen Gibson 8, Simon Davies 9, Nicola J Wiles 3. 

Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT

David Kessler 1, Alison Burns 1, Debbie Tallon 1, Glyn Lewis 2, Stephanie MacNeill 3, Jeff Round 4, William Hollingworth 4, Carolyn Chew-Graham 5, Ian Anderson 6, John Campbell 7, Chris Dickens 7, Una Macleod 8, Simon Gilbody 9, Simon Davies 10, Tim J Peters 11, Nicola Wiles 1. 

The value of an embedded qualitative study in a trial of a second antidepressant for people who had not responded to one antidepressant: understanding the perspectives of patients and general practitioners

Carolyn A Chew-Graham 1, Thomas Shepherd 2, Heather Burroughs 2, Katie Dixon 2, David Kessler 3.
MOSAICs – Managing OSteoArthritis In ConsultationS in Primary Care Professor Elaine Hay

Dziedzic KS, Healey EL, Porcheret M, Ong BN, Main C, Jordan KP, Lewis AM, Edwards JJ, Jinks C, Morden A, McHugh GA, Ryan S, Finney A, Jowett S, Oppong R, Afolabi E, Pushpa-Rajah A, Handy J, Clarkson K, Mason E, Whitehurst T, Hughes RW, Croft, P, Hay EM. Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care - the Management of OsteoArthritis In Consultations (MOSAICS) study protocol. Implementation Science 2014 Aug 27;9(1):95. [Epub ahead of print]

Morden A, Jinks C, Ong BN, Porcheret, M Dziedzic. Acceptability of a 'guidebook' for the management of Osteoarthritis: a qualitative study of patient and clinician's perspectives. BMC Musculoskelet Disord. 2014 Dec 13;15:427. doi: 10.1186/1471-2474-15-427

Ong BN, Morden A, Brooks L, Porcheret M, Edwards J, Sanders S, Jinks C, Dziedzic KS (2014). Changing policy and practice: making sense of national guidelines for osteoarthritis. Social Science and Medicine, vol. 106, pp101-109.


Implementing the MSK-HQ to empower patients and improve services
Dr Jonathan Hill  

Trial Name

Chief Investigator



Professor George Peat

Professor Peter Croft

Thomas E, Wilkie R, Peat G, Hill S, Dziedzic K, Croft P. The North Staffordshire Osteoarthritis Project – NorStOP: Prospective, 3-year study of the epidemiology and management of clinical osteoarthritis in a general population of older adults. BMC Musculoskeletal Disorders 2004;5:2. 

NOTEPAD Professor Carolyn Chew-Graham

A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: The NOTEPAD study Protocol

Heather Burroughs 1, Bernadette Bartlam 1, Mo Ray 2, Tom Kingstone 1 3, Tom Shepherd 1, Reuben Ogollah 1, Janine Proctor 1, Waquas Waheed 4, Peter Bower 4, Peter Bullock 4, Karina Lovell 5, Simon Gilbody 6, Della Bailey 6, Stephanie Butler-Whalley 1, Carolyn Chew-Graham 7 8.

Trial Name

Chief Investigator



Dziedzic, K., Hill, J., Lewis, M., Sim, J., Daniels, J., & Hay, E. M. Effectiveness of manual therapy or pulsed shortwave diathermy in addition to advice and exercise for neck disorders: a pragmatic randomized controlled trial in physical therapy clinics. Arthritis & Rheumatology 2005;53(2):214-222. doi: 10.1002/art.21087

Lewis, M., James, M., Stokes, E., Hill, J., Sim, J., Hay, E., & Dziedzic, K. An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial. Rheumatology 2007;46(11):1701-1708. doi: 10.1093/rheumatology/kem245
PD-CRAFT 2 Professor Simon Davies  

Salisbury C, Foster NE, Bishop A et al. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial. BMC Health Serv Res 2009;9:136

Salisbury C, Montgomery AA, Hollinghurst S, Hopper C, Bishop A, Franchini A, Kaur S, Coast J, Hall J, Grove S, Foster NE. Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems: pragmatic randomised controlled trial. BMJ 2013 Jan 29:346:f43. doi: 10.1136/bmj.f43

Hollinghurst, S., Coast, J., Busby, J., Bishop, A., Foster, N. E., Franchini, A., Grove, S., Hall, J., Hopper, C., Kaur, S., Montgomery, A. A., & Salisbury, C. A pragmatic randomised controlled trial of ‘PhysioDirect’ telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation. BMJ Open 2013; 3:e003406. doi: 10.1136/bmjopen-2013-003406

Bishop, A., Gamlin, J., Hall, J., Hopper, C., & Foster, N. E. PhysioDirect: supporting physiotherapists to deliver telephone assessment and advice services within the context of a randomised trial. Physiotherapy 2013;99(2):113-118. doi: 10.1016/

Foster NE, Williams B, Grove S, Gamlin J, Salisbury C. The evidence for and against ‘PhysioDirect’ telephone assessment and advice services. Physiotherapy 2011;97:78 – 82. DOI: 10.1016/

Rathod T, Belcher J, Montgomery AA, Salisbury C, Foster N. Health services changes: is a run-in period necessary before evaluation in randomised clinical trials? Trials 2014 Jan 30;15:41. doi: 10.1186/1745-6215-15-4
POST – Primary care Osteoarthritis Screening Trial Professor George Peat

Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST)

L A Barnett 1, M Lewis 2, C D Mallen 2, G Peat 2. 

PMR PATIENT Prof Christian Mallen

This paper describes the study in more detail; Muller S, Hider S, Helliwell T, Bailey J, Barraclough K, Cope L, Dasgupta B, Foskett R, Hughes R, Mayson Z, Purcell C, Roddy E, Wathall S, Zwierska I, Mallen CD. The epidemiology of polymyalgia rheumatica in primary care: a research protocol. BMC Musculoskelet Disord. 2012 Jun 15;13:102

Our first findings from the study won a prize from the Royal College of General Practitioners. Research Paper of the Year (Category 6: Endocrinology (incl. Diabetes), Gastroenterology, Musculoskeletal and Trauma, and Dermatology): Muller S, Hider SL, Helliwell T, Lawton S, Barraclough K, Dasgupta B, Zwierska I, Mallen CD. Characterising those with incident polymyalgia rheumatica in primary care: results from the PMR Cohort Study. Arthritis Res Ther. 2016 Sep 7;18:200.

This paper describes what patients think caused their PMR: Tshimologo M, Saunders B, Muller S, Mallen CD, Hider SL. Patients' views on the causes of their polymyalgia rheumatica: a content analysis of data from the PMR Cohort Study. BMJ Open. 2017;7(1):e014301.

This paper describes symptoms reported by PMR that could be related to another condition called giant cell arteritis: Masson W, Muller S, Whittle R, Helliwell T, Mallen C, Hider S. Possible giant cell arteritis symptoms are common in newly diagnosed patients with Polymyalgia Rheumatica: results from an incident primary care PMR cohort. BMC Rheumatology 2017;1:7

PRELIM Dr Ross Wilkie  
RACER Professor Nadine Foster

Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)

Chris Littlewood 1, Marcus Bateman 2, Kendra Cooke 3, Susie Hennnings 3, Tina Cookson 4, Kieran Bromley 3, Martyn Lewis 3, Lennard Funk 5, Jean Denton 6, Maria Moffatt 5, Rachel Winstanley 7, Saurabh Mehta 7, Gareth Stephens 8, Lisa Dikomitis 9, Linda Chesterton 9, Nadine E Foster 3.

Trial Name

Chief Investigator


SAMBA – Staffordshire Arthritis Musculoskeletal and Back Assessment Study Professor Elaine Hay

Roddy E, Zwierska I, Dawes P, Hider SL, Jordan KP, Packham J, Stevenson K, Hay E. The Staffordshire Arthritis, Musculoskeletal, and Back Assessment (SAMBA) Study: a prospective observational study of patient outcome following referral to a primary-secondary care musculoskeletal interface service. BMC Musculoskeletal Disorders 2010;11:6;

Roddy E, Zwierska I, Jordan KP, Dawes P, Hider SL, Packham J, Stevenson K, Hay EM. Musculoskeletal clinical assessment and treatment services at the primary-secondary care interface: an observational study. Br J Gen Pract 2013;63(607):141-8;

Roddy E, Jordan KP, Oppong RA, Chen Y, Jowett S, Dawes PT, Hider S, Packham J, Stevenson K, Zwierska I, Hay EM. Re-consultation, self-reported health status, and costs following treatment at a Musculoskeletal Clinical Assessment and Treatment Service (CATS): a twelve-month prospective cohort study. BMJ Open 2016;6(10):e011735;

Hill JC, Afolabi EK, Lewis M, Dunn KM, Roddy E, van der Windt DA, Foster NE. Does a modified STarT Back Tool predict outcome with a broader group of musculoskeletal patients than back pain? A secondary analysis of cohort data. BMJ Open 2016;6(10):e012445;
SCIATIC (Lead CTU: Bangor) SubCutaneous Injection of Adalimumab Trial compared with Control Dr Nefyn Williams (Bangor)


Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC) : a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica. / Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare.

Yn: Health Technology Assessment, Cyfrol 21, Rhif 60, 31.10.2017, t. 1-180.

Allbwn ymchwil: Cyfraniad at gyfnodolyn › Erthygl


SCiatica Outcomes in Primary Care
Professor Nadine Foster

The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol

Nadine E Foster 1 2, Kika Konstantinou 3, Martyn Lewis 1 2, Reuben Ogollah 1 2, Kate M Dunn 1, Danielle van der Windt 1, Ruth Beardmore 2, Majid Artus 1, Bernadette Bartlam 1, Jonathan C Hill 1, Sue Jowett 1 4, Jesse Kigozi 1 4, Christian Mallen 1, Benjamin Saunders 1, Elaine M Hay 1.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial

Kika Konstantinou 1 2, Martyn Lewis 1 3, Kate M Dunn 1, Reuben Ogollah 4, Majid Artus 1, Jonathan C Hill 1, Gemma Hughes 3, Michelle Robinson 3, Benjamin Saunders 1, Bernadette Bartlam 1 5, Jesse Kigozi 6, Sue Jowett 1 6, Christian D Mallen 1, Elaine M Hay 1, Danielle A van der Windt 1, Nadine E Foster 1 3.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

Nadine E Foster 1 2, Kika Konstantinou 1 3, Martyn Lewis 1 2, Reuben Ogollah 1 4, Benjamin Saunders 1, Jesse Kigozi 5, Sue Jowett 1 5, Bernadette Bartlam 1 6, Majid Artus 1, Jonathan C Hill 1, Gemma Hughes 2, Christian D Mallen 1, Elaine M Hay 1, Danielle A van der Windt 1, Michelle Robinson 2, Kate M Dunn 1.


SHIPS – Study of Health trainers Improving Patient Self-management support

Dr Joanne Protheroe  


Professor Krysia Dziedzic

Dziedzic, K. S., Hill, S., Nicholls, E., Hammond, A., Myers, H., Whitehurst, T., Bailey, J., Clements, C., Whitehurst, D. G., Jowett, S., Handy, J., Hughes, R. W., Thomas, E., & Hay, E. M. Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses. BMC Musculoskeletal Disorders 2011;12: 156. doi: 10.1186/1471-2474-12-156

Dziedzic, K., Nicholls, E., Hill, S., Hammond, A., Handy, J., Thomas, E., & Hay, E. Self-management approaches for osteoarthritis in the hand: a 2x2 factorial randomised trial. Annals of the Rheumatic Diseases. 2013 Oct 9 doi: 10.1136/annrheumdis-2013-203938 [Epub ahead of print]


Professor Christian Mallen

Hay EM, Thomas E, Paterson SM, Dziedzic K, Croft PR. A pragmatic randomised controlled trial of local corticosteroid injection and physiotherapy for the treatment of new episodes of unilateral shoulder pain in primary care. Annals of the Rheumatic Diseases 2003;62:394-399.

Dziedzic, K., Stevenson, K., Thomas, E., Sim, J., & Hay, E. Development and implementation of a physiotherapy intervention for use in a pragmatic randomized controlled trial in primary care for shoulder pain. Musculoskeletal Care 2009;7(2):67-77. doi: 10.1002/msc.151

James M, Stokes EA, Thomas E, Dziedzic K, Hay EM. Cost minimisation analysis of local corticosteroid injection and physiotherapy for the treatment of new episodes of unilateral shoulder pain in primary care. Rheumatology 2005;44:1447-1451.

Thomas E, Croft PR, Paterson SM, Dziedzic K, Hay EM. What influences participants' treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain. British Journal of General Practice 2004;54:93-96.



STAMP – Smartphone and Tablet Application for Medicines and Pain

Professor Daniella van der Windt  


Professor Nadine Foster

Hay, E. M., Dunn, K. M., Hill, J. C., Lewis, M., Mason, E. E., Konstantinou, K., Sowden, G., Somerville, S., Vohora, K., Whitehurst, D., & Main, C. J. A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol. BMC Musculoskeletal Disorders 2008;9:58. doi: 10.1186/1471-2474-9-58

Hill, J. C., Whitehurst, D. G., Lewis, M., Bryan, S., Dunn, K. M., Foster, N. E., Konstantinou, K., Main, C. J., Mason, E., Somerville, S., Sowden, G., Vohora, K., & Hay, E. M. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet 2011;378(9802):1560-1571. doi: 10.1016/s0140-6736(11)60937-9

Main, C. J., Sowden, G., Hill, J. C., Watson, P. J., & Hay, E. M. Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406). Physiotherapy 2012;98(2):110-116. doi: 10.1016/

Whitehurst, D. G., Bryan, S., Lewis, M., Hill, J. C., Hay, E. M. Exploring the cost-utility of stratified primary care management for low back pain compared with current best practice within risk-defined subgroups. Annals of the Rheumatic Diseases 2012; 71(11):1796-802.

Hill, J. C., Dunn, K. M., Main, C. J., Hay, E. M. Subgrouping low back pain: A comparison of the STarT Back Tool with the Örebro Musculoskeletal Pain Screening Questionnaire. European Journal of Pain 2010;14(1):83-89. doi:10.1016/j.ejpain.2009.01.003

Hill, J.C. The early identification of patients with complex back pain problems. The Back Care Journal. Spring 2010.

Hill, J. C., Vohora, K., Dunn, K. M., Main, C. J., & Hay, E. M. Comparing the STarT Back Screening Tool's Subgroup Allocation of Individual Patients With That of Independent Clinical Experts. Clinical Journal of Pain 2010;26(9):783-787. doi: 710.1097/AJP.1090b1013e3181f1018aac.

Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, et al. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis & Rheumatism 2008;59(5):632–41.

STEMS – Stepping up the evidence for Musculoskeletal Services

Professor Nadine Foster

Bishop, A., Tooth, S., Protheroe, J., Salisbury, C., Ogollah, R.O., Jowett, S., Hay, E.M., Foster, N.E., and on behalf of the STEMS study team. A pilot cluster radomised controlled trial to investigate the addition of direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain: the STEMS pilot trial protocol (ISRCTN23378642). Pilot and Feasibility Studies 2015, 1:26 doi: 10.1186/s40814-015-0020-4



SUPPORT – Subacromial imPingement syndrome and Pain, A randomised controlled trial of exercise and injection

Professor Nadine Foster Roddy, E., Zwierska, I., Hay, E. M., Jowett, S., Lewis, M., Stevenson, K., van der Windt, D., & Foster, N. E. Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial). BMC Musculoskeletal Disorders 2014;15:81. doi: 10.1186/1471-2474-15-81

SWAP – Study of Work And Pain

Professor Nadine Foster Bishop, A., Wynne-Jones, G., Lawton, S. A., van der Windt, D., Main, C., Sowden, G., Burton, A. K., Lewis, M., Jowett, S., Sanders, T., Hay, E. M., & Foster, N. E. Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669). BMC Musculoskeletal Disorders 2014;15: 232. doi: 10.1186/1471-2474-15-232

Trial Name

Chief Investigator


The TAPS Study

(STarTMSK Trial)
Professor Nadine Foster

Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial

Benjamin Saunders 1, Jonathan C Hill 2, Nadine E Foster 2 3, Vince Cooper 2, Joanne Protheroe 2, Adrian Chudyk 2, Carolyn Chew-Graham 2, Bernadette Bartlam 2 4. 

Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial

J C Hill 1, S Garvin 2, Y Chen 3 2, V Cooper 3, S Wathall 3 2, B Saunders 3, M Lewis 3 2, J Protheroe 3, A Chudyk 3, K M Dunn 3, E Hay 3, D van der Windt 3, C Mallen 3, N E Foster 3 2. 

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial

Jonathan Hill 1, Stefannie Garvin 2, Ying Chen 1, Vincent Cooper 1, Simon Wathall 2, Bernadette Bartlam 3, Benjamin Saunders 1, Martyn Lewis 1, Joanne Protheroe 1, Adrian Chudyk 1, Hollie Birkinshaw 1, Kate M Dunn 1, Sue Jowett 4, Raymond Oppong 4, Elaine Hay 1, Danielle van der Windt 1, Christian Mallen 1, Nadine E Foster 1. 

Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial

Prof Jonathan C Hill, PhD, Stefannie Garvin, BA, Kieran Bromley, MSc, Benjamin Saunders, PhD, Jesse Kigozi, PhD, Vince Cooper, MD, Martyn Lewis, PhD, Prof Joanne Protheroe, PhD, Simon Wathall, HND, Adrian Chudyk, PhD, Prof Kate M Dunn, PhD, Hollie Birkinshaw, PhD, Prof Sue Jowett, PhD, Prof Elaine M Hay, MD, Prof Danielle van der Windt, PhD, Prof Christian Mallen, PhD, Prof Nadine E Foster, PhD


Professor Daniella van der Windt

Chesterton, L. S., van der Windt, D. A., Sim, J., Lewis, M., Mallen, C. D., Mason, E. E., Warlow, C., Vohora, K., & Hay, E. M. Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084). BMC Musculoskeletal Disorders 2009;10: 156. doi: 10.1186/1471-2474-10-156

Chesterton, L. S., Lewis, A. M., Sim, J., Mallen, C. D., Mason, E. E., Hay, E. M., & van der Windt, D. A. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial). BMJ 2013;347:f5160. doi: 10.1136/bmj.f5160

Tennis Elbow Trial

Professor Peter Croft

Hay, E.M., Paterson, S.M., Lewis, M., Hosie, G., Croft, P. Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. BMJ 1999;319:964-968.

Lewis, M., Hay, E., Paterson, S., Croft, P. Local Steroid Injections for Tennis Elbow: Does the Pain Get Worse Before it Gets Better?: Results From a Randomized Controlled Trial. Clinical Journal of Pain 2005;21(4):330-334.

Lewis, M., Hay, E.M., Paterson, S.M., Croft, P. Effects of manual work on recovery from lateral epicondylitis. Scandinavian Journal of Work and Environmental Health 2002;28(2):109-116.

The Low Back Pain Trial

Professor Peter Croft

Hay, E. M., Mullis, R., Lewis, M., Vohora, K., Main, C. J., Watson, P., Dziedzic, K. S., Sim, J., Minns Lowe, C., Croft, P. R. Comparison of physical treatments versus a brief pain management programme for back pain in primary care: a randomised clinical trial in physiotherapy practice. Lancet 2005;365:2024–2030.

Whitehurst, D. G., Lewis, M., Yao, G. L., Bryan, S., Raftery, J. P., Mullis, R., & Hay, E. M. A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial. Arthritis & Rheumatism 2007;57(3):466-473. doi: 10.1002/art.22606

Mullis, R., Dziedzic, K. S., Lewis, M., Minns Lowe, C. J., Main, C. J., Watson, P. J., Hay, E. M. Validation of complex interventions in a low back pain trial: selective video analysis cross-referenced to clinical case notes. Contemporary Clinical Trials 2006;27(5): 404-412. doi: 10.1016/j.cct.2006.05.004



Hay, E. M., Foster, N. E., Thomas, E., Peat, G., Phelan, M., Yates, H. E., Blenkinsopp, A., & Sim, J. Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial. BMJ 2006;333(7576):995. doi: 10.1136/bmj.38977.590752.0B

Phelan, M., Blenkinsopp, A., Foster, N. E., Thomas, E., Hay, E. M. Pharmacist-led medication review for knee pain in older adults: content, process and outcomes, International Journal of Pharmacy Practice 2008;16:347-355.


Dr Edward Roddy