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Rheumatology Advance Access originally published online on October 14, 2006
Rheumatology 2007 46(4):631-637; doi:10.1093/rheumatology/kel355
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© The Author 2006. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

A longitudinal study exploring pain control, treatment and service provision for individuals with end-stage lower limb osteoarthritis

G. A. McHugh, K. A. Luker, M. Campbell, P. R. Kay1 and A. J. Silman2

School of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester M13 9PL, 1Department of Orthopaedics, Wrightington, Wigan and Leigh NHS Trust, Wrightington Hospital, Appley Bridge, Wigan, Lancashire WN6 9EP and 2School of Epidemiology and Health Sciences, University of Manchester, Oxford Road, Manchester M13 9PT, UK.

Correspondence to: G. A. McHugh, School of Nursing, Midwifery and Social Work, University of Manchester, Oxford Road, Manchester M13 9PL, UK. E-mail: gretl.mchugh{at}manchester.ac.uk


   Abstract
Top
 Abstract
Introduction
 Participants and methods
 Results
 Discussion
 Conclusion
 Acknowledgements
 References
 
Objective. To investigate the level of pain control, treatment and service provision amongst individuals with end-stage lower limb osteoarthritis who were on the waiting list for hip or knee joint replacement.

Methods. A total of 105 patients on a waiting list for primary knee or hip replacement from a regional orthopaedic centre in the UK were recruited. The study was longitudinal and based on direct interviews at baseline and 6 months, with a postal questionnaire at 3 months. Data were collected on pain by a visual analogue scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. In addition, medication and the use of services and treatments were recorded.

Results. Participants experienced high levels of pain as measured by VAS [mean 7.0; 95% confidence interval (CI) 6.6–7.5] and WOMAC pain (mean 11.2; 95% CI 10.6–11.9). The majority of participants (78, 74%) was taking analgesics more than once a day. Primary care utilization was variable. Of the 74 (70%) participants who had consulted their GP in the previous 3 months, 41 (55%) had not discussed their pain or osteoarthritis during these consultations. Just below one-third of participants (31, 30%) reported to have received information on osteoarthritis.

Conclusions. Pain appears to be difficult to manage in individuals with end-stage lower limb osteoarthritis. Individuals appeared not to be taking appropriate levels of analgesia in relation to levels of pain. Improvements are required in the provision of information on pain and osteoarthritis. Patients would benefit from more proactive management by health professionals (especially by GPs).

KEY WORDS: Longitudinal study, Service provision, Pain, Osteoarthritis, Joint replacement, Waiting list


   Introduction
Top
 Abstract
 Introduction
Participants and methods
 Results
 Discussion
 Conclusion
 Acknowledgements
 References
 
The United Nations, the World Health Organization (WHO), governments and patients’ organizations have declared the years 2000–2010 as the ‘bone and joint decade’ [1]. In order to improve management, these organizations have identified the need to increase the recognition and understanding of the burden posed by musculoskeletal diseases, which include osteoarthritis (OA).

OA is a debilitating disease. The most common symptom in OA of the hip and knee is pain, in particular pain on movement, resulting in individuals restricting their activities of daily living. Despite an evidence base for treatments and guidelines for managing pain [2–6], health professionals find the assessment and management of people with chronic pain a real challenge; and some have expressed frustration and concerns about the inadequacies in the way patients with chronic pain are managed [7, 8].

In the UK, Arthritis and Musculoskeletal Alliance (ARMA) has developed standards of care specifically for OA [9]. The standards are based on the following principles:

  • Access to information, support and knowledge that optimize musculoskeletal health for everyone and enable self-management.
  • Access to the right services that enable early diagnosis and treatment.
  • Access to ongoing and responsive treatment and support.
In the development of the ARMA standards for OA, the key focus has been on the user's perspective with an emphasis on health service provision in order to improve the care and treatment for individuals living with OA [9]. The British League Against Rheumatism (BLAR) has also developed nationally agreed standards for arthritis [10]. The focus is on what organizations and health professionals should do in caring for an individual with OA or rheumatoid arthritis. For example, within primary care, a GP would be expected to explain the usual treatments and services available. It also includes standards on what information should be provided to individuals with arthritis. Whether these standards are well known and accepted by health professionals is not clear.

The progression and impact of OA has been well researched with one cohort study of patients with OA showing that the disease resulted in high levels of physical disability and high level of utilization of healthcare, including joint replacement after 8 yrs [11]. Studies that examine health service provision have been undertaken on patients at an early stage of OA [12] and other chronic pain conditions [8, 13]. The investigation of service provision and management of OA, while on the waiting list for joint replacement, provides a more useful model for investigating the appropriateness of pain control. This group typically has end-stage disease with nocturnal pain being a key indication for surgery.

The overall aim of the study was to investigate the level of pain control, treatment and service provision amongst individuals with end-stage lower limb OA who were on the waiting list for hip or knee joint replacement. We also explored information provision and needs in relation to OA.


   Participants and methods
Top
 Abstract
 Introduction
 Participants and methods
Results
 Discussion
 Conclusion
 Acknowledgements
 References
 
Design
The study was longitudinal and based on direct interviews at baseline and 6 months, with a postal questionnaire at 3 months. Patient follow-up was undertaken to allow for patient change during the waiting period and to determine what services and treatments were used while on the waiting list for joint replacement.

Participants
A similar study found the mean (S.D.) change score for Western Ontario and McMaster Universities (WOMAC) pain from inclusion to just before the operation to be 0.9 (3.1) [14]. Using nQuery Advisor 4, a sample size of 96 is required for a paired t-test to detect a difference in means of 0.9 with a S.D. of 3.1, assuming two-sided 5% significance and 80% power. Allowing for 10% attrition, a starting sample size of 107 would be sufficient; with 20% attrition, a starting sample size of 120 would be required. It was expected to lose participants at each follow-up due to the joint replacement operation. Study participants, with a confirmed clinical and radiographic diagnosis of OA of the hip or knee awaiting joint replacement were recruited from the waiting list of a regional orthopaedic centre. Consecutive subjects who lived in a defined geographical area were eligible to be interviewed.

Over a 3-month period in 2003, there were 182 potential participants. After excluding 22 ineligible subjects (Fig. 1), 160 eligible potential participants were identified and invited to take part, by post. Local Research Ethical Committee approval was obtained and UK research governance arrangements were followed.


Figure 1
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  		FIG. 1. Study recruitment.

 
Methods
Data were collected using a structured interview schedule at baseline and 6 months, which was researcher-administered in the participant's own home. This structured interview schedule comprised elements used in previous studies [13] and was extensively piloted prior to data collection. The interviews covered the following areas: demographic and personal information, current experience of pain and OA, current medication, past and current use of treatments (including complementary therapies) for the management of pain, previous and recent referral to and use of services, and information provision on OA and pain management.

Pain was measured using a 10 cm visual analogue scale (VAS) and the WOMAC OA index was used to measure pain, physical function and stiffness. The range for WOMAC pain is 0–20, physical function 0–68 and stiffness 0–8, with a higher score indicating more severity. The validity, reliability and responsiveness (i.e. ability to detect change) of these tools have been extensively tested [15–20]. Details on analgesic and other related medication were collected by a question on the interview schedule that asked about ‘current’ medication and a 7-day medication diary was also used. Study participants were asked to record all medications taken whether on prescription or over the counter for a 1-week period. The advantage of this mode of data collection is that it is affected less by recall bias [21]. Pain medication was then grouped according to the WHO classification [22] consisting of a three-step treatment ladder. This system had been developed for cancer pain relief, but the same principles can be applied to individuals with chronic non-malignant pain. According to the WHO analgesic ladder, mild pain (step one) is treated with non-opioids (e.g. aspirin, paracetamol); non-steroidal anti-inflammatory drugs (NSAIDs) with or without adjuvants (antidepressants, anticonvulsants). Moderate pain (step two) is treated with weak opioid analgesics (e.g. codeine, tramadol) with or without non-opioids and adjuvants. Severe pain (step three) is treated with strong opioids such as morphine, fentanyl with or without adjuvants.

The postal questionnaire at 3 months collected data on pain, physical function and medication.

Data analysis
Data from the questionnaires were entered into Microsoft® Access and analysed using SPSSTM. Changes between the time points are presented as mean difference with 95% CI. For continuous variables, data were compared using the independent samples t-test with the probability level of P ≤ 0.05. The associations between analgesic level and pain measurement levels were examined using Kendall's tau correlation.


   Results
Top
 Abstract
 Introduction
 Participants and methods
 Results
Discussion
 Conclusion
 Acknowledgements
 References
 
After a second reminder to initial non-responders (56), 105 (66%) (Fig. 1) agreed to be interviewed. There were no important demographic differences (i.e. age, gender and area of residence) between study participants and the 55 non-participants. This sample represented about 15% of the total number of primary hip and knee joint replacements from the hospital over a 1 yr period.

At the 3-month postal follow-up, there were only three non-responders, but these individuals were followed up at the 6-month interview. Participants were lost from the study owing to their having had operations by the third month (18) and sixth month (38) data collection points.

Demographics
Characteristics of study participants are shown in Table 1. Study participants were roughly equally divided between those waiting for a hip replacement (48, 46%) and a knee replacement (57, 54%). The median length of time since diagnosis with OA of the hip was reported at 48 months [interquartile range (IQR) 22.5–132] and was considerably longer for OA of the knee with a median of 132 months (IQR 96–216).


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  		TABLE 1. Characteristics of participants

 
Pain
At baseline, the majority of the participants (66, 63%) described their pain as ‘always’ present with 28 (27%) of participants describing pain as ‘often’ present, nine (9%) described pain as ‘sometimes’ present and two (2%) as being present ‘very little’. As measured by VAS and WOMAC pain at baseline, 3 months and 6 months, the majority of study participants was experiencing pain levels that were considered to be severe [4] (Table 2).


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  		TABLE 2. Measures of VAS pain and WOMAC at baseline, 3 months and 6 months

 
Physical function
As measured by WOMAC, physical functioning was greatly affected with a mean score of 40.3 (S.D. 12.1) (Table 2). While on the waiting list, physical functioning deteriorated at 3 months from baseline, and this was statistically significant [mean difference 4.8 (S.D. 8.9), 95% CI for mean 2.8, 6.7]. Levels of stiffness in the joint did not change significantly while on the waiting list.

Medication use
The majority of participants (78, 74%) was taking medication for pain (analgesics and NSAIDs) more than once a day. There was little difference in the level of frequency between individuals awaiting a hip or knee replacement. Most participants (73, 72%) were taking non-opioid analgesics, such as paracetamol or co-proxamol (Table 3). Around two-thirds of study participants were prescribed or were taking NSAIDs. Participants may have been taking NSAIDs for different comorbidities and not just for OA.


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  		TABLE 3. Specific medication for pain

 
According to the WHO classification [22], the majority of the study participants (82, 81%) was being managed with non-opioids and/or NSAIDs (step one of the WHO analgesic ladder); 18 (18%) were prescribed ‘moderate’ analgesics such as weak opioids (e.g. codeine, tramadol) and NSAIDs (step two), and only one individual was on analgesics taking a strong and weak opioid and NSAID, regarded as step three for severe pain management. In this study, most participants (31, 31%) were on one NSAID and one non-opioid. The next most common combination was one non-opioid (22, 22%) and then one NSAID (11, 11%).

The association between the participants’ pain levels with their WHO analgesic classification was assessed. The one participant who was prescribed analgesic medication in the severe WHO classification did have a VAS pain score at the extreme level (10 cm). The mean VAS pain score was slightly lower for those on moderate analgesia (6.8, S.D. 2.4) as compared with mild analgesia (7.0, S.D. 2.1), which may suggest a better level of pain control. However, when WOMAC pain was compared with the WHO classification, pain levels were higher for those on a ‘moderate’ analgesic level (12.2, S.D. 2.8) as compared with the mild level (11.1, S.D. 3.5).

Using a t-test, there were no significant differences between mean VAS pain with WHO classification (95% CI difference –0.9, 1.4; t = 0.40; df = 98; P = 0.688) and mean WOMAC pain with WHO classification (95% CI difference –2.8, 0.7; t = –1.21; df = 98; P = 0.229) for those individuals on mild or moderate pain medication. Only those individuals on mild and moderate pain relief were compared given the small numbers of individuals in the ‘no medication’ and ‘severe’ pain relief categories.

Using Kendall's correlation, there was no significant correlation between WHO pain classification and VAS pain scores (Kendall's correlation <0.01; P > 0.999). However, when the association between WOMAC pain and WHO classification was explored, there was a positive correlation between WHO pain classification and WOMAC pain scores (Kendall's correlation = 0.18; P = 0.032). Owing to the lack of significant differences between pain scores in the mild and moderate categories, this finding needs to be interpreted with caution. This conflicting evidence from Kendall's correlations also highlights that VAS pain and WOMAC pain pick up different aspects of pain, and therefore do not always show the same thing.

Despite an increase in pain levels as measured by VAS and WOMAC pain at 3 months (n = 84) and at 6 months (n = 47) (Table 2), there was little change in frequency of medication at 6 months. For the majority of participants (33, 70%), the frequency of taking pain medication at 6 months had not changed from that reported at baseline. Five participants (11%) reported a reduced frequency and nine participants (19%) reported an increase in frequency of those who remained in the study.

Other treatments
Participants reported to have tried a number of treatments to help relieve the symptom of pain (Table 4). Just under half of study participants (51, 49%) reportedly had tried physiotherapy treatments at some time with many using heat or cold packs for short-term pain relief. The physiotherapy treatments of heat and exercise were found to be helpful and of benefit in improving mobility and pain, but often these sessions would only be provided for a period of 6 weeks.


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  		TABLE 4. Types of treatments used reported at baseline and while on waiting list

 
Transcutaneous electrical nerve stimulation (TENS) and steroid injections were treatments reportedly tried by around one-third of study participants. Glucosamine was used by 13 (12%) study participants. There were a number of participants who had paid for complementary therapies, such as acupuncture, reflexology and osteopathy.

The use of a number of treatments, such as heat treatment and TENS, by study participants to help manage pain was commonly reported. Study participants were asked if they found any benefit from using any of these treatments, and at baseline 61 (58%) participants had found some of the treatments used useful. The use of the different treatments while on the waiting list was low (Table 4) with only eight (17%) of the participants reporting having had physiotherapy treatments.

Use of services
Study participants reported on referrals by GP to other health professionals and the types of services before being placed on the waiting list and while on the waiting list for joint replacement. Just below half of the participants reported to have been referred by their GP to a physiotherapist (50, 48%) and 21% (22) to a rheumatologist after having OA. Referrals by GPs to a pain clinic (8, 8%), a complementary therapist (4, 4%) or nurses (district nurses 2, 2%; health visitors 0, 0%; rheumatology nurses 2, 2%) were low.

The current use of primary care and hospital services was low at both baseline and at 6 months. Only two participants (4%) reported currently receiving physiotherapy at 6 months compared with six participants (6%) who reported receiving the service at baseline (Table 5). The involvement of community nurses (district nurses and health visitors) and specialist nurses in the management and care of these individuals was minimal.


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  		TABLE 5. Currently receiving services at baseline and six months

 
There were also no participants who had ever been referred to an occupational therapist for assessment prior to going on the waiting list, and only one participant had seen an occupational therapist while on the waiting list, only because she had been in hospital with a minor stroke. She had received equipment and advice on how to manage with her poor physical function and inability to carry out activities of daily living.

At the 6-month interview, participants reported that referrals by their GP to other specialists in the previous 6 months were low. Only two participants (4%) had been referred to another health professional, one to a rheumatologist and the other to a physiotherapist.

Primary care utilization while on the waiting list was variable; however, participants reported seeing their GP more for other problems than for OA or pain management. Over half the study participants (41, 55%), even though they consulted the GP in the previous 3 months, had not discussed pain or OA during these consultations. The majority of study participants perceived that as they were on the waiting list for joint replacement, there was nothing else that could be done and they would just ‘put up’ with the pain. Data on pain as a reason for GP contact were analysed to examine the relationship between the participant's pain scores, as measured by VAS and WOMAC pain and the number of times the individuals saw the GP for pain management. Using Kendall's correlation, there were no significant correlations shown between VAS pain rating (Kendall's coefficient 0.91; P = 0.243) and WOMAC pain (Kendall's coefficient 0.12; P = 0.093) and the number of times individuals saw their GP for pain management. Comparing mean attendance to see GP at baseline (2.9, S.D. 2.2) and 6 months (1.5, S.D. 1.9) there was no significant differences in mean attendances (95% CI for difference –0.3, 1.2; t = 1.26; df = 46; P = 0.215). Around one-third of study participants (39, 37%) reported having had difficulty in getting to their GP's surgery.

Information provision
The provision of information for study participants on pain management was poor. Only 11 (10%) study participants had received information specifically on managing pain prior to going on the waiting list. Five of these participants had received information from a pain specialist—one from their own GP and a pain specialist; two from a physiotherapist, two participants from their GP and one participant had found her own information through a health magazine. While on the waiting list, only one participant received information on pain management, which was from her GP during a medication review. Most of the patients commented that, when they went to their GP because of pain, they were prescribed analgesics or NSAIDs but felt that they were never given an explanation on how to best manage their pain or what other treatments were available.

The provision of information for study participants about OA was only slightly better. After being diagnosed with OA, just below one-third of the participants (31, 30%) reported that they had been provided with information on OA. Little information was given by health professionals. Ten (10%) of the study participants reported that they had obtained by themselves leaflets concerning arthritis; two had researched on the Internet; and six reported to have received verbal information about OA from health professionals [rheumatologist (2), physiotherapist (2); GP (2)]. While on the waiting list, none of the participants had received any information regarding management of their OA.

Information needs
The participants’ main focus for improvement in information was around the need for more information on the options for the management of OA, including advice on medication management and pain control. It was apparent during the interviews that some participants did not know what some of the medications they were prescribed were for, and around 20% of participants reported using their own regime to taking analgesics without guidance from health professionals.


   Discussion
Top
 Abstract
 Introduction
 Participants and methods
 Results
 Discussion
Conclusion
 Acknowledgements
 References
 
This study was conducted at the time of great change in the health service specifically the ‘waiting list initiative’, which was aimed at reducing waiting time for operations. Some participants had their joint replacement sooner than was anticipated, resulting in fewer participants at each follow-up period. Not withstanding this, the originality of the study has been the investigation of service provision and treatments in individuals awaiting joint replacement, which has shown that, despite high levels of pain, there was little use of health services and treatments for pain management by these individuals. Over half the study participants consulted their GP, but despite reported difficulties in managing symptoms, did not discuss pain or OA during these consultations. Many participants perceived that they just had to put up with pain until their joint replacement because there was nothing else that could be done.

In a review by McQuay and Moore [4], VAS scores of 7.0 or greater as measured by a 10 cm scale are indicative of severe pain, and this study reported a mean VAS of 7.0 (S.D. 2.2). Given that the high levels of pain and restricted functioning as measured by WOMAC are the criteria for joint replacement surgery, these findings are consistent with findings from other studies [14, 15, 23, 24].

The difficulties that patients reported in the management of OA, and the lack of active intervention by GPs, consultants and other health professionals on the waiting list, clearly demonstrate the need for more proactive care to improve symptom management. It appeared that joint replacement was seen as a ‘cure’ and participants were just waiting for their operation to get symptom relief. However, despite waiting list initiatives in England, there is still a wait for surgery with some individuals having to wait up to a year from referral to operation and others not being fit enough to have their operation. These findings suggest that management of symptoms associated with end-stage OA are suboptimal. There has been recognition by ARMA and the Arthritis Research Campaign (ARC) of the need to improve standards of care and service delivery for individuals with OA [9, 25]. In particular, ARMA recommends that individuals with OA have access to ongoing and responsive treatment and support as well as regular reviews of treatment and choice of pain relief [9]. The data collection for the study reported here predates the ARMA guidelines; nevertheless, one-third of the participants were having difficulty getting to their GPs’ surgery. Despite high analgesia use among participants the majority were still experiencing severe levels of pain, which was of concern. This suggests individuals were taking analgesics that were not effective for the pain they were experiencing or that individuals were not receiving adequate analgesics.

Over the past 5 yrs there has been much debate in the health service on how to manage chronic diseases [26–28]. Having a key worker who can enable individuals to access support has been recognized by ARMA [9]. Study participants may have benefited from an assessment of their health and social care needs, and this was not carried out. There was little awareness of the kinds of living aids or home adaptations that were available. Community nurses appeared to have no input into the care and management of individuals with OA despite their training to assess the needs of individuals and refer to other agencies such as social services for support with living. This lack of involvement by nurses was an interesting finding considering the UK government's strategy is for nurses to become more involved in managing and caring for individuals with long-term conditions [26–28]. It may have been that primary health professionals were not aware of these individuals because they had been referred to an orthopaedic specialist and hence were transferred to secondary care. However, it also raises the question of whether health professionals are underestimating the impact of OA and see it as part of the ‘normal’ ageing process.

Self-management of chronic diseases is also high on the UK government's agenda, and strategic guidance has been provided for health professionals on the management of long-term conditions so that patients become experts at managing their chronic condition [29]. ARMA has also recommended standards regarding access to information, support and knowledge [9]. Study participants were trying to self-manage their symptoms but were not effective. In addition, the provision of information for patients on OA and pain management was minimal. An earlier study found that less than half of the patients studied recalled having been informed of the adverse effects of NSAIDs [30]. One national survey reported that people living with chronic diseases are not able to take effective action to manage their health problems [31]. Findings from this study have shown that there is a need for clear information to be provided for patients to facilitate effective management of symptoms associated with OA, including an understanding of the medication taken. It also raises the issue of whether health professionals themselves require additional training in this area.

This study has a number of limitations. First, there may have been a possible non-response bias with one-third of those eligible not responding. However, to reduce non-response bias, information was sought on non-responders to determine the extent to which they were different from responders. Although pain levels could not be obtained from non-responders, all potential participants had been assessed by the orthopaedic surgeon as requiring a hip or knee joint replacement. Second, it needs to be taken into account that the study population are individuals at the end-stage of OA and are not representative of less severely affected individuals with OA. Third, recall bias, which affects the internal validity of the study, may have been a problem in this study as it was examining previous referrals by GPs to other health professionals and the use of treatments by participants. Remembering this information may have been difficult for some participants. However, when collecting information about treatments, participants were asked as to who had provided the treatment, and so this enabled cross-checking of information on whether referrals to health professionals had taken place.


   Conclusion
Top
 Abstract
 Introduction
 Participants and methods
 Results
 Discussion
 Conclusion
Acknowledgements
 References
 
There is a drive in the UK for the NHS to improve service delivery and care for individuals with chronic diseases. The ARMA standards may be one step forward in achieving this. However, difficulties around the implementation of standards and guidelines and use by health professionals are well recognized [32]. Despite waiting-list initiatives, there will still be a considerable wait for surgery, with some individuals ultimately not having their operation necessitating the need for better coordination and management of care in both primary and secondary care for people with end-stage OA. The findings suggest a need to redesign how services are being delivered, including an exploration of health professionals’ involvement in the management of individuals with OA especially with regard to information provision. In addition, the predicted increase in prevalence of OA necessitates the need for the health professionals and the NHS to focus on improving service provision and care for these individuals.

Formula


   Acknowledgements
Top
 Abstract
 Introduction
 Participants and methods
 Results
 Discussion
 Conclusion
 Acknowledgements
References
 
We are grateful to the study participants of this research. G.M. was supported by a Department of Health National Primary Care Research Development Award.

The authors have declared no conflicts of interest.


   References
Top
 Abstract
 Introduction
 Participants and methods
 Results
 Discussion
 Conclusion
 Acknowledgements
 References
 

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Submitted 1 June 2006; Accepted 15 September 2006


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