PEDro celebrated its 15th anniversary in October 2014. The PEDro Partnership decided to recognise this occasion by identifying 15 of the most significant randomised controlled trials in physiotherapy ever published.
We invited PEDro users to nominate randomised controlled trials in physiotherapy for consideration. Nominations were judged by a panel of international physiotherapy trialists.
These are the Top 15 Trials in physiotherapy. The first authors of the top 15 trials are from 7 countries, with the United Kingdom and Australia each having 4 trials, the United States of America and Norway each having 2 trials, and Sweden, Netherlands and Brazil each having 1 trial.
Apart from clustering the trials according to the condition being treated, these trials are in no particular order.
These are ground-breaking trials that changed the way people are treated for a variety of conditions seen by physiotherapists and other healthcare professionals. Some of these trials set the stage for breakthroughs, some represent a paradigm shift, and all of them mark important milestones in the evolution of physiotherapy treatment.
- Efficacy of traction for non-specific low back pain: a randomised clinical trial
Beurskens AJ, de Vet HC, Koke AJ, Lindeman E, Regtop W, van der Heijden GJ, Knipschild PG
Lancet 1995 Dec 16;346(8990):1596-1600
Nominators commented that this was a rigorous, cleverly designed trial of a (then) common practice. The trial changed practice by disproving claims that traction is effective for people with low back pain.
- Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial
Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM
Lancet 2011 Oct 29;378(9802):1560-1571
This trial report was included because it incorporated a new approach of subgrouping patients using a biopsychosocial paradigm and the analysis included cost-effectiveness. The results showed that a stratified approach, by use of prognostic screening with matched pathways, would have important implications for the management of back pain in primary care globally.
- The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial
Machado LAC, Maher CG, Herbert RD, Clare H, McAuley JH
BMC Medicine 2010 Jan 26;8(10):Epub
The trial found, that when added to the currently recommended first-line care of acute low back pain, a treatment program based on the McKenzie method does not produce appreciable additional short-term improvements in pain, disability, function or global perceived effect or reduce patient’s risk of developing persistent symptoms.
- Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial
Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO, Spindler MF, McAuley JH
Lancet 2007 Nov 10-16;370(9599):1638-1643
This trial was nominated because it was a very large, high quality trial, published in a top quality journal. It showed that people with acute low back pain receiving recommended first-line care do not recover more quickly with the addition of diclofenac (non-steroidal anti-inflammatory drug) or spinal manipulative therapy.
- Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain
Frost H, Klaber Moffett JA, Moser JS, Fairbank JC
BMJ 1995 Jan 21;310(6973):151-154
This 1995 trial was nominated because it was one of the first to support the use of active treatment in the field of low back pain. This paper represents a paradigm shift because it showed there was a role for supervised fitness training programs in the management of moderately disabled people with chronic low back pain.
- Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial
Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B
BMJ 2006 Nov 4;333(7575):939-944
Nominators said this trial had direct impact on practice, with superiority of physiotherapy as a first choice of treatment instead of medical intervention for tennis elbow. The trial showed physiotherapy combining elbow manipulation and exercise was superior to wait and see in the first six weeks and to corticosteroid injections after six weeks, providing a reasonable alternative to injections in the mid to long term.
- Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis. A randomized controlled trial
Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V, Forbes A
JAMA 2002 Sep 18;288(11):1364-1372
One nominator commented: “This was a beautiful trial that needed to be done”. The trial found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided extracorporeal shock wave therapy over placebo in people with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.
- Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial
Olsen OE, Myklebust G, Engebretsen L, Holme I, Bahr R
BMJ 2005 Feb 26;330(7489):449-455
This trial was nominated because it was one of the early trials, and one of the best trials, looking at sports injury prevention. “It was a difficult cluster-randomised design conducted well”. It found that a structured program of warm-up exercises can prevent knee and ankle injuries in young people playing sports. Preventive training should therefore be introduced as an integral part of youth sports programs.
- Additional task-related practice improves mobility and upper limb function early after stroke: a randomised controlled trial
Blennerhassett J, Dite W
Australian Journal of Physiotherapy 2004;50(4):219-224
Nominators highlighted this trial because it was the first of its kind for inpatient stroke rehabilitation. The trial has changed clinical practice in inpatient stroke rehabilitation as it supported the use of additional task-related practice and showed the circuit class format was a practical and effective means to provide supervised additional practice that led to significant and meaningful functional gains.
- Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D, for the EXCITE Investigators
JAMA 2006 Nov 1;296(17):2095-2104
Nominators said this trial was the first large multicenter randomised controlled trial in stroke rehabilitation, setting the stage for many of the trials that followed. This trial had a significant impact on the clinical practice. Among people who had a stroke within the previous 3 to 9 months, constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year.
- Physiotherapy for Bell’s palsy
Mosforth J, Taverner D
British Medical Journal 1958 Sep 13;2(5097):675-677
This 1958 trial is significant because it was one of the first trials evaluating a physiotherapy treatment. It found no significant benefit from the use of galvanic stimulation for Bell’s palsy.
Read the transcript of an interview with Mr Lázaro Teixeira, who included this trial in his Cochrane review entitled Physical therapy for Bell’s palsy (idiopathic facial paralysis).
- An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial
Greening NJ, Williams JEA, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, Vincent EE, Chimera R, Morgan MD, Singh SJ, Steiner MC
BMJ 2014 Jul 8;349:g4315
This trial was nominated because it showed that early rehabilitation during hospital admission for an exacerbation of chronic respiratory disease did not reduce the risk of subsequent readmission or enhance recovery of physical function following the event over 12 months compared to usual care. Mortality at 12 months was higher in the intervention group. The results indicate that current standard physiotherapy practice should not be abandoned in favour of progressive exercise rehabilitation in the early stages of a chronic obstructive pulmonary disease exacerbation.
- Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP
Lancet 2009 May 30;373(9678):1874-1882
This trial was significant because, although physiotherapists have a long history of initiating rehabilitation in the intensive care unit, the effects were probably limited by heavy sedation protocols and lack of dedicated rehabilitation time in the patient’s management. The trial demonstrated that a strategy for whole-body rehabilitation (consisting of interruption of sedation and physical and occupational therapy in the earliest days of critical illness) was safe, well tolerated, and resulted in better functional outcomes at hospital discharge, a shorter duration of delirium, and more ventilator-free days compared with standard care.
- Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women
Bø K, Talseth T, Holme I
BMJ 1999 Feb 20;318(7182):487-493
Nominators supported this trial because it was the first rigorous evaluation of the effects of pelvic floor muscle training for stress urinary incontinence, and was the start of evidence-based women’s health physiotherapy. It showed that training of the pelvic floor muscles was superior to electrical stimulation and vaginal cones in the treatment of stress incontinence.
- High-intensity functional exercise program and protein-enriched energy supplement for older persons dependent in activities of daily living: a randomised controlled trial
Rosendahl E, Lindelof N, Littbrand H, Yifter-Lindgren E, Lundin-Olsson L, Haglin L, Gustafson Y, Nyberg L
Australian Journal of Physiotherapy 2006;52(2):105-113
The FOPANU (Frail Older People – Activity and Nutrition study in Umeå) trial was the first trial evaluating high-intensity functional exercise for older people in residential care facilities with severe cognitive and physically impairment (including those with dementia). A high-intensity functional exercise program had positive long-term effects in balance, gait ability, and lower-limb strength. An intake of protein-enriched energy supplement immediately after the exercises did not appear to increase the effects of the training.