Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256]
© Luijsterburg et al; licensee BioMed Central Ltd. 2004
Received: 17 September 2004
Accepted: 09 November 2004
Published: 09 November 2004
The objective is to present the design of randomised clinical trial (RCT) on the effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syndrome (also called sciatica).
Patients in general practice diagnosed with an acute (less than 6 weeks) lumbosacral radicular syndrome and an age above 18 years are eligible for participation. The general practitioners treatment follows their clinical guideline. The physical therapy treatment will consist of patient education and exercise therapy. The primary outcome measure is patients reported global perceived effect. Secondary outcome measures are severity of complaints, functional status, health status, fear of movement, medical consumption, sickness absence, costs and treatment preference. The follow-up is 52 weeks.
Treatment by general practitioners and physical therapists in this study will be transparent and not a complete "black box". The results of this trial will contribute to the decision of the general practitioner regarding referral to physical therapy in patients with an acute lumbosacral radicular syndrome.
Why a design article?
Publishing the design of the trial has several advantages. It may prevent publication bias . A study producing positive results seems more likely to be published than a study that reports no or negative results [2, 3]. Also, the study can be included in systematic reviews because data can be retrieved from the researcher . Publishing the design of a study before the results are available provides an opportunity to reflect critically on the design of the study, irrespective of the results. Also, a design article provides detailed information about the intervention within the trial to care givers.
The lumbosacral radicular syndrome (LRS) is a complex of symptoms related to the lumbosacral nerve roots. The LRS is a disorder with radiating pain in the leg below the knee in one or more lumbar or sacral dermatomes, and can be accompanied by phenomena associated with nerve root tension or neurological deficits (i.e. sensory deficits in the leg, decreased muscle strength in the leg, decreased reflexes, urinary problems) [4–7]. A prolapsed disc is a frequent cause of LRS, but other causes include spinal or lateral recess stenosis, tumours and radiculitis [4, 5, 7, 8]. The incidence of LRS in the Netherlands is estimated at 5 per 1000 persons a year .
Most patients seeking medical care in the Netherlands will first visit a general practitioner (GP), who is regarded as the 'gatekeeper' of the health care system. The majority of health problems presented to GPs are treated by the GPs themselves and they are responsible for most referrals to (para) medical specialists. In 1996 the Dutch College of General Practitioners published their clinical guideline for LRS . There is consensus that treatment of LRS in the first six to eight weeks should be conservative. The exact content of the conservative treatment is yet not clear . Since the study of Vroomen et al.  bed rest is not regarded a treatment option for LRS anymore.
Primarily, treatment consists of adequate pain medication, giving information about the natural course of LRS, which in general is favourable, and stimulating to continue the normal daily activities of the patient. GPs in the Netherlands largely comply with the recommendations stated in the clinical guideline regarding management in patients with LRS . However, they deviated regarding the referral to physical therapy (PT), almost half of patients with LRS were referred, whereas this was not recommended in the guideline. No specific patients characteristics could be found for the prescription of physical therapy. So, in general practice referral to PT in patients with LRS is common. However, there is a lack of knowledge of the effectiveness of PT in LRS. Therefore, the aim of this article is to present the design of a randomised clinical trial of conservative treatment (general practitioners and physical therapy) in patients with acute LRS.
Randomisation will take place after baseline measurement by the research assistant. We use a concealed randomisation procedure using a computer generated randomisation list developed by an independent person. Patients' specific and unique trial number will be typed in a special developed database (i.e. not editable for research assistant and a second randomisation action using the same trial number is not possible) and the random allocation will appear on screen. In order to prevent unequal treatment group sizes, block randomisation will be used with blocks of 10 patients . This means that after every 10th patient the number of patients allocated to both treatment groups is equal. Towards every randomised patient will be explained that the management of their complaint by his or her GP will be continued. Patients who are allocated to physical therapy will be shown a list of participating physical therapists of which he or she can make a choice. The research assistant makes the first appointment with the physical therapist most easily accessible by the patient.
For obvious reasons GPs and PTs are not blinded for treatment allocation. But they are not involved with treatment effect measurements. The patients cannot be blinded because of the ethical reasons as stated by the Medical Ethical Committee. The researcher is involved in the statistical analysis, but the analysis and interpretation of the findings will be audited and verified by an independent and not involved statistician. In this trial the primary outcome measurement and most of the secondary outcome measurements will be scored by the patients. Studies from Ostelo et al  and Scholten-Peeters et al  mentioned that in this type of study patients are blinded to a certain extent because they are unaware of the exact content of both treatments or may be called naive to the content of the treatment not received. Other more or less similar designed trials from Vroomen et al  and Hofstee et al  reported that it is not possible to blind participating patients for allocated treatment. Therefore, we think it is important to know any treatment preference of the patients at baseline. Supplementary analysis may show to what extent this effects the scores on outcome measurements of the patients.
PT treatment will imply information and advice about LRS and exercise therapy. Passive modalities such as massage, manipulation techniques or applying applications (e.g. ultra sound or current waves) are not allowed in the PT treatment. This PT treatment protocol was accomplished in a consensus meeting with participating PTs. The PT will report what kind of information/ advice and what type of exercise the patient receives in each session. Both GP and PT intervention will be restricted to a maximum of 9 treatments/ consultations in the first 6 weeks after randomisation.
In the Netherlands, PTs are mainly taught the biomechanic model . This model focuses on somatic issues; it assumes a causal relation between tissue damage and pain. PT could be of additional value in the management of patients with LRS because PTs are 'the experts' in treating musculoskeletal disorders with exercises and advice/ information. The pain reported by a patient is used as guidance to determine the intensity of the exercises and the advice about resuming normal daily activities and work. This study assumes that focussing on (pain) complaints with exercises and advice is the optimal PT treatment in the acute phase (0 to 6 weeks) of LRS.
It is possible that patients may suffer from a fear of movement because of pain . Good advice/ information will reassure these patients and exercises will show them that movement is possible. So, the secondary treatment goal of the PT is to decrease the possibly present fear of movement in these patients.
This trial attempts to enrol 182 patients with LRS, 91 patients in both treatment groups. This sample size is regarded sufficient to detect a difference of 20% (with a α of 0.05 and a power of 80%) in the primary outcome (GPE) between the two treatment groups. A difference of 20% is considered to be clinically relevant .
Primary outcome measure
The primary outcome measure is the Global Perceived Effect (GPE), measured on a 7 points scale ranging from 1 = completely recovered to 7 = vastly worsened. It is regarded a clinical relevant outcome measure and is regarded valid and responsive to measure the patients' perceived benefit [18–20].
Secondary outcome measures
Pain severity of the leg and the back will be scored on a 11 points Visual Analogue Scale (VAS) ranging from 0 = no pain to 10 = unbearable pain. Reliability, validity and responsiveness of the VAS have been shown [21–23].
The functional status will be measured with the Roland Morris Disability Questionnaire (RDQ) for sciatica . The scoring of the RDQ is achieved by counting the number of positive responses: a patient individual score can vary from 0 (no disability) to 24 (severe disability). The RDQ has proved to be a valid instrument and appears to be responsive for clinical relevant changes [20, 25–28].
Health status will be measured by the 36-item short form (SF-36)  and the Euroqol (EQ-5D) instrument [30, 31]. Validity and responsiveness on both SF-36 [32–34] and EQ-5D [35–37] proved to be sufficient.
Fear of movement will be measured by the Tampa scale for kinesiophobia (TSK) [38, 39]. The TSK consists of 17 items; each rated on a 4-point likert scale. The TSK has been shown to be a valid and responsive instrument [40, 41].
Costs will be calculated and include LRS related sickness absence from work, medical consumption (i.e. medication use, additional therapies, visits to health care providers), out-of-pocket expenses and paid help. Patients' treatment preference will be evaluated at baseline and at 4 follow-up measurements.
Baseline comparability will be investigated by descriptive statistics to examine whether randomisation was successful. If necessary, adjustments for baseline variables will be performed in the analysis. Group differences and 95% confidence intervals will be calculated for all outcome measures. The statistical analysis will be performed according tot the intention-to-treat principle, analysing the patients in the treatment group to which they were randomly allocated. Between group differences will be calculated using the Student t-test for continuous variables or Chi-Square for dichotomous variables. In addition a per-protocol analysis will be performed, analysing only those patients with no serious protocol deviations. Comparing the results of the intention-to-treat and the per-protocol analysis will indicate if and to what extent protocol deviations might have biased the results. Multivariate regression analysis will be conducted to examine the influence of baseline variables on outcome.
This article introduces a design of a RCT to evaluate the additional effectiveness of PTs management added to GPs management in patients with LRS. The study is designed in a way that GP and PT treatment is transparent (according a guideline and a consensus meeting) and not a complete "black box". The results of this trial will contribute to the decision of the GP regarding referral of patients with LRS to PT. The inclusion of patients will run until the end of the year 2004. The follow-up measurements will be completed in the end of the year 2005.
- Dickersin K: The existence of publication bias and risk factors for its occurrence. JAMA. 1990, 263: 1385-1389. 10.1001/jama.263.10.1385.View ArticlePubMedGoogle Scholar
- Dickersin K, Rennie D: Registering clinical trials. JAMA. 2003, 290: 516-523. 10.1001/jama.290.4.516.View ArticlePubMedGoogle Scholar
- Schork MA: Publication bias and meta analysis. J Hypertens. 2003, 21: 243-245. 10.1097/00004872-200302000-00007.View ArticlePubMedGoogle Scholar
- Stam J: [Consensus in diagnosing and treatment of the lumbosacral radicular syndrome] Consensus over diagnostiek en behandeling van het lumbosacrale radiculaire syndroom. Ned Tijdschr Geneeskd. 1996, 140: 2621-2627.PubMedGoogle Scholar
- Smeele IJM, van den Hoogen JMM, Mens JMA, Chavannes AW, Faas A, Koes BW, Romeijnders ACM, van der Laan JR: [NHG-guideline Lumbosacral Radicular Syndrome] NHG-Standaard Lumbosacraal Radiculair Syndroom. Huisarts en Wetenschap. 1996, 39: 78-89.Google Scholar
- Ostelo RW, de Vet HC, Waddell G, Kerckhoffs MR, Leffers P, van Tulder M: Rehabilitation following first-time lumbar disc surgery: a systematic review within the framework of the cochrane collaboration. Spine. 2003, 28: 209-218. 10.1097/00007632-200302010-00003.PubMedGoogle Scholar
- Weber H, Holme I, Amlie E: The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam. Spine. 1993, 18: 1433-1438.View ArticlePubMedGoogle Scholar
- Health Council of the Netherlands: Management of the lumbosacral radicular syndrome (sciatica). The Hague. 1999, publication no. 1999/1918Google Scholar
- Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA: Conservative treatment of sciatica: a systematic review. J Spinal Disord. 2000, 13: 463-469. 10.1097/00002517-200012000-00001.View ArticlePubMedGoogle Scholar
- Vroomen PC, de Krom MC, Wilmink JT, Kester AD, Knottnerus JA: Lack of effectiveness of bed rest for sciatica. N Eng Jl of Med. 1999, 340: 418-423. 10.1056/NEJM199902113400602.View ArticleGoogle Scholar
- Luijsterburg PAJ, Verhagen AP, Braak S, Oemraw A, Avezaat CJJ, Koes BW: General practitioners' management of LRS compared with a clinical guideline.
- Roberts C, Torgerson D: Randomisation methods in controlled trials. BMJ. 1998, 317: 1301-View ArticlePubMedPubMed CentralGoogle Scholar
- Ostelo RW, Koke AJ, Beurskens AJ, de Vet HC, Kerckhoffs MR, Vlaeyen JW, Wolters PM, Berfelo MW, van den Brandt PA: Behavioral-graded activity compared with usual care after first-time disk surgery: considerations of the design of a randomized clinical trial. J Manipulative Physiol Ther. 2000, 23: 312-319.PubMedGoogle Scholar
- Scholten-Peeters GG, Verhagen AP, Neeleman-van der Steen CW, Hurkmans JC, Wams RW, Oostendorp RA: Randomized clinical trial of conservative treatment for patients with whiplash-associated disorders: considerations for the design and dynamic treatment protocol. J Manipulative Physiol Ther. 2003, 26: 412-420. 10.1016/S0161-4754(03)00092-7.View ArticlePubMedGoogle Scholar
- Hofstee DJ, Gijtenbeek JM, Hoogland PH, van Houwelingen HC, Kloet A, Lotters F, Tans JT: Westeinde sciatica trial: randomized controlled study of bed rest and physiotherapy for acute sciatica. J Neurosurg Splne. 2002, 96: 45-49.View ArticleGoogle Scholar
- Vlaeyen JW, Linton SJ: Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000, 85: 317-332. 10.1016/S0304-3959(99)00242-0.View ArticlePubMedGoogle Scholar
- Philadelphia Panel: Evidence-based clinical practice guidelines on selected rehabilitation interventions: overview and methodology. Phys Ther. 2001, 81: 1629-1640.Google Scholar
- Fries JF: Toward an understanding of patient outcome measurement. Arthritis Rheum. 1983, 26: 697-704.View ArticlePubMedGoogle Scholar
- Bombardier C, Tugwell P, Sinclair A, Dok C, Anderson G, Buchanan WW: Preference for endpoint measures in clinical trials: results of structured workshops. J Rheumatol. 1982, 9: 798-801.PubMedGoogle Scholar
- Bombardier C: Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine. 2000, 25: 3100-3103. 10.1097/00007632-200012150-00003.View ArticlePubMedGoogle Scholar
- Revill SI, Robinson JO, Rosen M, Hogg MI: The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976, 31: 1191-1198.View ArticlePubMedGoogle Scholar
- Sriwatanakul K, Kelvie W, Lasagna L, Calimlim JF, Weis OF, Mehta G: Studies with different types of visual analog scales for measurement of pain. Clin Pharmacol Ther. 1983, 34: 234-239.View ArticlePubMedGoogle Scholar
- Carlsson AM: Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983, 16: 87-101. 10.1016/0304-3959(83)90088-X.View ArticlePubMedGoogle Scholar
- Roland M, Morris R: A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983, 8: 141-144.View ArticlePubMedGoogle Scholar
- Deyo RA: Comparative validity of the sickness impact profile and shorter scales for functional assessment in low-back pain. Spine. 1986, 11: 951-954.View ArticlePubMedGoogle Scholar
- Deyo RA: Measuring the functional status of patients with low back pain. Arch Phys Med Rehabil. 1988, 69: 1044-1053.PubMedGoogle Scholar
- Beurskens AJ, de Vet HC, Koke AJ, van der Heijden GJ, Knipschild PG: Measuring the functional status of patients with low back pain. Assessment of the quality of four disease-specific questionnaires. Spine. 1995, 20: 1017-1028.View ArticlePubMedGoogle Scholar
- Beurskens AJ, de Vet HC, Koke AJ: Responsiveness of functional status in low back pain: a comparison of different instruments. Pain. 1996, 65: 71-76. 10.1016/0304-3959(95)00149-2.View ArticlePubMedGoogle Scholar
- Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30: 473-483.View ArticlePubMedGoogle Scholar
- The EuroQol Group: EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16: 199-208. 10.1016/0168-8510(90)90421-9.View ArticleGoogle Scholar
- The Euroqol Group: Not a quick fix. Health Serv J. 1991, 101: 29-Google Scholar
- McHorney CA, Ware JE, Lu JF, Sherbourne CD: The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994, 32: 40-66.View ArticlePubMedGoogle Scholar
- McHorney CA, Ware JE, Raczek AE: The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993, 31: 247-263.View ArticlePubMedGoogle Scholar
- Haley SM, McHorney CA, Ware JE: Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale. J Clin Epidemiol. 1994, 47: 671-684. 10.1016/0895-4356(94)90215-1.View ArticlePubMedGoogle Scholar
- Essink-Bot ML, Stouthard ME, Bonsel GJ: Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993, 2: 237-246.View ArticlePubMedGoogle Scholar
- Carr-Hill RA: Health related quality of life measurement – Euro style. Health Policy. 1992, 20: 321-328. 10.1016/0168-8510(92)90164-7. discussion 329–332View ArticlePubMedGoogle Scholar
- van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ: Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Soc Sci Med. 1994, 39: 1537-1544. 10.1016/0277-9536(94)90005-1.View ArticlePubMedGoogle Scholar
- Vlaeyen JW, Kole-Snijders AM, Boeren RG, van Eek H: Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995, 62: 363-372. 10.1016/0304-3959(94)00279-N.View ArticlePubMedGoogle Scholar
- Kori SH, Miller RP, Todd DD: Kinesophobia: a new view of chronic pain behaviour. Pain Manage. 1990, Jan/Feb: 35-43.Google Scholar
- Swinkels-Meewisse IE, Roelofs J, Verbeek AL, Oostendorp RA, Vlaeyen JW: Fear of movement/(re)injury, disability and participation in acute low back pain. Pain. 2003, 105: 371-379. 10.1016/S0304-3959(03)00255-0.View ArticlePubMedGoogle Scholar
- Swinkels-Meewisse EJ, Swinkels RA, Verbeek AL, Vlaeyen JW, Oostendorp RA: Psychometric properties of the Tampa Scale for kinesiophobia and the fear-avoidance beliefs questionnaire in acute low back pain. Man Ther. 2003, 8: 29-36. 10.1054/math.2002.0484.View ArticlePubMedGoogle Scholar
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/5/39/prepub