The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial.Background
Study design
Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture. In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179Background
Methods
This study aimed to examine how physical activity and health-related quality of life (HRQoL) evolved over the first year after total knee replacement (TKR) for patients with and without post-operative chronic knee pain. 83 adults participating in the PEP-TALK, a RCT testing the effectiveness of a behaviour change physiotherapy intervention versus usual rehabilitation post-primary TKR, were analysed. UCLA Activity Score and EQ-5D-5L values for participants with and without chronic knee pain (14 points or lower in the Oxford Knee Score Pain Subscale at six months post-TKR) were compared at six and 12 months post-TKR. We evaluated recovery trajectory those with or without chronic pain at these time points.Abstract
INTRODUCTION
METHODS
To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds.Purpose and background
Methods and results
This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement. 533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours.Abstract
Introduction
Methodology
The increase in prescription opioid misuse and dependence is now a public health crisis in the UK. It is recognized as a whole-person problem that involves both the medical and the psychosocial needs of patients. Analyzing aspects of pathophysiology, emotional health, and social wellbeing associated with persistent opioid use after injury may inform safe and effective alleviation of pain while minimizing risk of misuse or dependence. Our objectives were to investigate patient factors associated with opioid use two to four weeks and six to nine months after an upper limb fracture. A total of 734 patients recovering from an isolated upper limb fracture were recruited in this study. Opioid prescription was documented retrospectively for the period preceding the injury, and prospectively at the two- to four-week post-injury visit and six- to nine-month post-injury visit. Bivariate and multivariate analysis sought factors associated with opioid prescription from demographics, injury-specific data, Patient Reported Outcome Measurement Instrumentation System (PROMIS), Depression computer adaptive test (CAT), PROMIS Anxiety CAT, PROMIS Instrumental Support CAT, the Pain Catastrophizing Scale (PCS), the Pain Self-efficacy Questionnaire (PSEQ-2), Tampa Scale for Kinesiophobia (TSK-11), and measures that investigate levels of social support.Aims
Methods
To evaluate implementation of the Back Skills Training (BeST) programme in clinical practice within the National Health Service (NHS). The BeST programme is a group Cognitive Behavioural Approach (CBA) for people with persistent (≥6 weeks) low back pain (LBP). This intervention has been shown to be clinically and cost-effective in a large pragmatic trial. To aid implementation of the BeST programme, an online training intervention (iBeST) was developed.Purpose of study
Background
We wished to assess the feasibility of a future randomised controlled
trial of parathyroid hormone (PTH) supplements to aid healing of
trochanteric fractures of the hip, by an open label prospective
feasibility and pilot study with a nested qualitative sub study.
This aimed to inform the design of a future powered study comparing
the functional recovery after trochanteric hip fracture in patients
undergoing standard care, We undertook a pilot study comparing the functional recovery
after trochanteric hip fracture in patients 60 years or older, admitted
with a trochanteric hip fracture, and potentially eligible to be
randomised to either standard care or the administration of subcutaneous
PTH for six weeks. Our desired outcomes were functional testing
and measures to assess the feasibility and acceptability of the
study.Aims
Patients and Methods
Chronic low back pain (CLBP) can be constant or episodic. Fluctuations are common. We present two different pictures of the CLBP experience; timelines illustrating back pain over time and ‘web diagrams’ showing a snapshot of a phase in time. Semi structured interviews from 34 participants from the UK BeST trial included timelines drawn collaboratively by the researcher and participant. Symptoms, events, treatment and consultations were arranged chronologically along a timeline. Initial thematic analysis on 63 interviews gave bio-psychosocial themes that were spoken about in an integrated way. Further analysis explored these interactions between themes. Interactions were classified as; helpful to recovery, unhelpful or mixed. Web diagrams were drawn for each interview and classified as Dense- mostly unhelpful interactions, Open – a combination of helpful and unhelpful interactions and Sparse – mostly helpful interactions.Background and Purpose
Methods
Impaired vascularity of the skin in elderly ankle fracture patients causes the skin and wound complications. This is part of a RCT comparing ORIF and close contact casting (CCC) for isolated unstable ankle fractures in patients >
60 years. Assessments over 6-months
trans-cutaneous O2 saturation (TcP02) of medial and lateral ankle skin Ankle-Brachial Pressure Index (ABPI). 3-vessel arterial duplex scan distal calf perforator artery patency. The uninjured limb was the control. Eighty-nine patients eligible; 59 participated (76% female). 30 randomised to ORIF; 29 to CCC. Each had one death and one withdrawal. Vascular data available on 55. Two patients had delays in wound healing (>
25% for >
6-weeks). Two further developed wound infections. No skin breakdowns in CCC group. There was a reduced TcP02 on day-3 in the injured limb. The TcP02 rose at 6-weeks compared to day-3 (medial 58mmHg; lateral 53mmHg, p=0.002) in the injured leg. At 6-months the TcP02 measurements were not different to uninjured leg. A critical TcP02 (<
20mmHg) found in 4, correlated with skin problems (p=0.003). Two of these had the only major delays in wound healing and one of the two wound infections. 94% of participants had normal ABPI’s (>
1.0). There was no difference between patients with or without an impaired ABPI (<
0.7 mm Hg) and wound problems (p=0.20). There was no difference in patent perforators between the injured and uninjured (p=0.39). Occult vascular insufficiency is present but at low incidence. ABPI and Duplex-US are insensitive for predicting infection or delayed healing. The ankle fracture injury does not disrupt the local perforators. TcPO2 is sensitive and specific for predicting skin problems. Impairment of skin oxygenation is transient. Current TcPO2 technology however is impractical as a clinical tool.
