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Special Issue |
Clinical Specialty Experts
(Orthopaedic Surgeon), American Academy of Orthopaedic Surgeons, USA
(Internist, Rheumatologist), American College of Physicians, USA
(Physiatrist)
(Internist), University of Pennsylvania, Philadelphia, Pa, USA
(Neurologist), American Academy of Neurology, USA
(Physical Therapist), American Physical Therapy Association, USA
(Physical Therapist), American College of Rheumatology, Association of Health Professionals, USA
(Physiatrist), American Academy of Physical Medicine and Rehabilitation, USA
(Internist), Cochrane Back Group
(Family Practice), American Academy of Family Physicians, USA
Ottawa Methods Group
(Public Health, specialization in epidemiology), Career Scientist, Ministry of Ontario Health (Canada), and Assistant Professor, Physiotherapy Program, School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada
(Epidemiology), Chair, Centre for Global Health, Institute of Population Health,, Ottawa, Ontario, Canada
(Epidemiology and Biostatistics), Professor and Chairman, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
(Kinesiology), Research Associate, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
(Medical Sociology), Medical Research Council Scholar, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
(Epidemiology), Research Associate, Department of Medicine, University of Ottawa and Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
Director of the Medical Library, Ottawa Hospital, Ottawa, Ontario, Canada
Research Associate, Department of Medicine, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
Program of Physiotherapy, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada
Address all correspondence and requests for reprints to: Peter Tugwell, MD, MSc, Chair, Centre for Global Health, Institute of Population Health, 1 Stewart St, Rm 312, Ottawa, Ontario, Canada K1N 6N5 (ptugwell{at}uottawa.ca)
| Abstract |
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Key Words: Clinical practice guidelines Evidence-based practice Meta-analysis Neckpain Physical therapy Practitioner feedback survey Rehabilitation Systematic reviews
| INTRODUCTION |
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The most commonly prescribed intervention for the management of neck pain by general practitioners is rest, followed by analgesics.3,4 Neck pain is one of the most common conditions for referral to a physical therapist. Despite the prevalence of neck pain, there is a lack of evidence for commonly used rehabilitation interventions.5 The most recent guidelines for the management of neck pain are the Quebec Task Force on Spinal Disorders (QTF)6 and the British Medical Journal (BMJ)7 guidelines. These guidelines are both in the process of being updated.
The purpose of this article is to describe the Philadelphia Panel evidence-based clinical practice guidelines (EBCPGs) of rehabilitation interventions for nonspecific neck pain. The aim of the developing the EBCPGs was to improve appropriate use of rehabilitation interventions for neck pain. The target users of these guidelines are physical therapists, physiatrists, orthopedic surgeons, rheumatologists, family physicians, and neurologists.
| METHODS |
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Studies were eligible if they were randomized controlled trials (RCTs), nonrandomized controlled clinical trials (CCTs), or case control or cohort studies that evaluated the intervention of interest in a population of more than 10 patients with nonspecific neck pain. Nonspecific neck pain was defined as pain in the neck area, with or without radiation to the extremities. The outcomes of interest were functional status, pain, ability to work, patient global improvement, patient satisfaction, and quality of life. The interventions included massage, thermal therapy (hot or cold packs), electrical stimulation, electromyographic (EMG) biofeedback, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, therapeutic exercises, and combinations of these rehabilitation interventions. Control groups that received active treatments were included. Concurrent interventions were allowed if they were given in the same way to both the experimental and control groups (eg, home exercises, educational booklets, advice on posture). However, concurrent interventions that were given to one group but not the other group were not accepted (eg, education by means of lectures for the control group was not accepted). No limitations based on methodological quality were imposed. Only English-, French-, and Spanish-language articles were accepted. Abstracts were not included.
A structured literature search was developed based on the sensitive search strategy for RCTs recommended by the Cochrane Collaboration8 and modifications proposed by Haynes et al.9 The search strategy was expanded to identify case control, cohort, and nonrandomized studies. The search was conducted in the electronic databases of MEDLINE, EMBASE, Current Contents, CINAHL, and the Cochrane Controlled Trials Register up to July 1, 2000. In addition, the registries of the Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Group and the Physiotherapy Evidence Database (PEDro) were searched. The references of all included trials were searched for relevant studies. Content experts were contacted for additional studies.
Two independent reviewers (VAR, JP) appraised the titles and abstracts of the literature search, using a checklist with the a priori defined selection criteria. Relevant studies were retrieved and the full articles were assessed by 2 independent reviewers for inclusion. Data were extracted by 2 independent reviewers from included articles, using predetermined extraction forms regarding the population characteristics, details of the interventions, trial design, allocation concealment, and outcomes. Methodological quality was assessed with a 5-point validated scale that assigns 2 points each for randomization and double-blinding and 1 point for description of withdrawals.10,11 Differences in data extraction and quality assessment were resolved by consensus.
| STATISTICAL ANALYSIS |
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Because prognosis is thought to be dependent on disease duration, the analysis was conducted for 2 categories of neck pain: acute (<4 weeks duration) and chronic (>12 weeks duration). If the population contained patients with mixed acute and chronic disease duration, the study was excluded.
Where possible, data from individual trials were combined using meta-analysis with the Review Manager (RevMan) computer program, Version 4.1 for Windows.* Continuous data were analyzed using weighted mean differences, where the difference between the treatment and control groups from each study included in the meta-analysis is weighted by the inverse of the variance and the outcome is reported in the original units (eg, centimeters). Where the same conceptual outcome was measured with different scales (eg, pain, functional status), the data were analyzed with standardized mean differences (SMDs). The SMD is calculated as the mean difference between treatment and control groups divided by standard deviation, and weighted by the inverse of the variance. Dichotomous data were analyzed using relative risk. The confidence that the different trials measured the same treatment effect (homogeneity of effect) was tested using a chi-square statistic. When homogeneity was not significant, fixed-effects models were used. With significant heterogeneity, random-effects models were used.
To calculate clinical improvement (defined as 15% improvement relative to a control), the absolute benefit and the relative difference in the change from baseline were calculated. Absolute benefit was calculated as the improvement in the treatment group less the improvement in the control group, in the original units. Relative difference in the change from baseline was calculated as the absolute benefit divided by the baseline mean (weighted for the treatment and control groups). For dichotomous data, the relative percentage of improvement was calculated as the difference in the percentage of improvement between the treatment and control groups.
The recommendations were graded by their level of evidence (I or II) and by the strength of evidence (A, B, or C). This grading system is shown in Table 1 and is described more fully elsewhere (see article titled "Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). Briefly, grade A recommendations indicate that a clinically important benefit (>15%) and statistical significance were shown in one or more RCTs. Grade B recommendations were assigned for interventions with a clinically important benefit (>15%) that is statistically significant in nonrandomized trials. Because there is less confidence in the results of nonrandomized studies, grade B recommendations required that the study be assigned a quality score of 3 or more on a 5-point scale (2 points for randomization, 2 points for blinding, 1 point for description of withdrawals). Grade C recommendations were assigned to interventions that have been compared with a control and have shown no evidence of effect in controlled trials. A master grid showing each rehabilitation intervention assessed and the strength and level of evidence is shown in Table 2. The report follows the same order as this grid (from left to right, top to bottom) for those interventions for which eligible studies were found.
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| RESULTS AND RECOMMENDATIONS |
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| ACUTE NECK PAIN (<4 WEEKS) |
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Efficacy:
No reliable data.
Strength of Published Evidence in Comparison With Other Guidelines:
The Philadelphia Panel found no evidence for traction for acute neck pain. This is in agreement with the QTF,6 which found no scientific evidence for traction for acute neck pain.
Recommendation:
The Philadelphia Panel recommended that there is insufficient evidence to include or exclude (ID) mechanical traction alone as an intervention for acute nonspecific neck pain.
TENS for Acute Neck Pain (<4 Weeks), Level I (RCT), Grade C for Pain (No Benefit Demonstrated)
Summary of Trials:
One RCT (N=20) of TENS (15 minutes, 3 per week at 0.2 milliseconds, 80 Hz) versus neck collar for patients with acute neck pain (<3 days) and no neurological signs was included.14
Efficacy:
None demonstrated. There was no difference in patient-assessed pain after 1 week or 3 months between a neck collar and TENS14 (Fig. 2).
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Clinical Recommendation in Comparison With Other Guidelines:
The Philadelphia Panel recommends that there is poor evidence to include or exclude TENS alone (grade C for pain) as an intervention for acute neck pain.
Interventions for Acute Neck Pain With Insufficient Evidence
No evidence from controlled trials or cohort studies was found for EMG biofeedback, thermotherapy, massage, electrical stimulation, therapeutic exercises, or combined interventions for acute neck pain.
For therapeutic exercises, one RCT of manual therapy combined with exercises was excluded because manual therapy was not given to the control group.15 Another RCT, which compared continuing normal activities with neck collar and time off work, was excluded because of lack of an appropriate control group (ie, the effects of neck collar and sick leave could not be separated).16
For combined interventions, one RCT of combined rehabilitation interventions was excluded because manual therapy was given to the treatment group but not to the control group.17
| CHRONIC NECK PAIN (>12 WEEKS) |
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Efficacy:
One CCT (N=47) found significant and clinically important patient global assessment with isometric exercises with a risk difference of 41% relative to an untreated control group21 (Tab. 6, Fig. 3). For group fitness classes, 2 RCTs (N=195) showed no difference between group classes and control for pain or sick leave at 1 or 6 months19,20 (Fig. 4). Individual sessions of therapeutic exercises that included proprioceptive re-education (consisting of slow neck movements to follow a moving target) relieved pain and improved functional status, by 36% and 33%, respectively, relative to a waiting list control in one RCT (N=60)18 (Tab. 7, Fig. 5).
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Clinical Recommendation in Comparison With Other Guidelines:
The Philadelphia Panel recommends that there is good evidence to include supervised exercise programs alone (including proprioceptive and traditional exercises) for the management of chronic (>12 weeks) neck pain (grade A for pain and function, grade B for patient global assessment).
Practitioner Agreement
Practitioner Comments
Panel's Response:
The 2 negative trials used group aerobic fitness programs and are shown in Figure 4. The Philadelphia Panel evaluated selected interventions, as described in the "Methods" section. This may not have been clear in the practitioner feedback survey. No trials of postural exercises were found. Stretching was a component of the effective programs and has now been included in the guideline statement.
Mechanical Traction for Chronic Neck Pain (>12 Weeks), Level II (CCT), Insufficient Data (ID)
Summary of Trials:
One CCT (N=73) of patients with cervical pain radiating to the extremities was excluded21 due to low quality (quality=0 out of 5). One RCT was excluded because the population included a mix of both patients with acute and chronic neck pain.26 One RCT of patients with cervical radiculopathy was excluded because no acceptable outcomes were measured (only EMG activity).27 One RCT of continuous traction was excluded because the patient population included a mix of patients with acute and chronic neck pain, which could not be separated.13
Efficacy:
Insufficient data. The excluded CCT demonstrated an improvement relative to the control (untreated group) in patient-assessed improvement with intermittent mechanical traction. However, due to the low quality of the trial, the validity of this effect is uncertain.
Strength of Published Evidence in Comparison With Other Guidelines:
The Philadelphia Panel found insufficient data for mechanical traction similar to the QTF,6 which found no scientific evidence.
Clinical Recommendation in Comparison With Other Guidelines:
There are insufficient data to make a recommendation regarding mechanical traction alone in chronic neck pain.
Therapeutic Ultrasound for Chronic Neck Pain (>12 Weeks), Level II, Grade C for Pain (No Evidence of Benefit)
Summary of Trials:
One RCT (N=26) of patients with myofascial trigger point neck pain was included.28
Efficacy:
None demonstrated. There was no difference in pain between therapeutic ultrasound and placebo therapeutic ultrasound. Other outcomes were not assessed (Fig. 6).
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Clinical Recommendation in Comparison With Other Guidelines:
The Philadelphia Panel recommends that there is poor evidence to include or exclude therapeutic ultrasound alone (grade C for pain) as an intervention for chronic neck pain.
Interventions for Chronic Neck Pain With Insufficient Data
Interventions that could not be assessed due to lack of controlled studies were EMG biofeedback, massage, thermotherapy, electrical stimulation, TENS, and combined rehabilitation interventions.
For combined interventions, one RCT was excluded because manual therapy was included in the "physiotherapy" group, but not the control group.29
| DISCUSSION |
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As for LBP, the effectiveness of conservative treatment of cervical syndrome is a complex issue.5,3134 Rehabilitation specialists often use concomitant treatment interventions within the same treatment session for a particular patient with a cervical syndrome. Certain rehabilitation interventions such as cryotherapy, ultrasound application, and massage are used for pain relief in the acute stage or as a treatment preparation before the main intervention.35 These treatment approaches are chosen based on empirical experience.35,36 The use of single and specific interventions does not reflect the complexity of the global approach adopted by rehabilitation specialists in clinical settings. The practice of rehabilitation requires a better theoretical basis37,38 supported by well-designed controlled research.39
The measurement of treatment effects is complex.40,41 Standardized measurement of outcomes is needed to facilitate scientific advances in clinical care for cervical syndromes. Little is known about valid and sensitive outcome measures in the spine.42 The Philadelphia Panel agreed that the primary outcomes of clinical importance are: pain, functional status, patient global assessment, quality of life, return to work, and patient satisfaction.
The effectiveness of physical rehabilitation interventions for cervical syndrome is affected by psychosocial, physical, and occupational factors.1,4354 Management recommendations suggest that these factors should be considered in the clinical evaluation of patients with cervical pain.48 These factors could not be addressed in this review.
Several methodological biases may be present in the clinical trials of cervical pain. The lack of precise diagnoses contributes to a misclassification bias.4,46,5560 For example, the terminology used to describe cervical syndrome was vague and included terms such as "tension neck," "frequent neck symptoms," and "cervical pain." A wide variety of clinical characteristics such as age, prevalent versus incident cases, stages of the disease, level of pain, and presence or absence of neurological deficits may have resulted in selection bias. Differences in disease duration were minimized in these guidelines by excluding studies with a mix of patients with acute and chronic conditions or mixed diagnoses. Characteristics of the device parameters and of the therapeutic application37 could also affect the treatment effect observed. The tendency for trials with nonsignificant results to not be published may result in an overestimate of the treatment effect due to publication bias.61 We could not assess the presence of publication bias due to the small number of trials. A language bias was introduced because the Philadelphia Panel reviewed only studies published in English, French, or Spanish.
The quality of studies on cervical syndrome rarely reached 2 out of 5 or greater on the Jadad scale (Appendix 2). Randomization (3/6 studies) was rarely fully adequate (ie, performed using computerized random number lists). Insufficient information about the treatment assignment procedure was noted in several RCTs. Inappropriate blinding (5/6 studies) could lead to an overestimate of the treatment effect. Complete blinding is difficult to achieve because of visual and other sensory differences between treatment and placebo as well as unintended communication between patient and evaluator.62 Few investigators (1/6 studies) reported adequate information regarding withdrawals and loss to follow-up or indicated whether they were considered in the data analysis. These weaknesses contribute to the lower quality assessment scores in many of the systematic reviews conducted on rehabilitation interventions for cervical syndrome.
Ottenbacher63 lists several difficulties for rehabilitation specialists: (1) discriminate between clinical and statistical significance, (2) low statistical power in detecting minimal clinical important differences, and (3) lack of replication of rehabilitation studies to strengthen evidence-based practice. Some studies (3/6 studies) did not use adequate sample sizes to detect important differences with confidence (Appendix 2). These issues contribute to nonconclusive results for several interventions. The Philadelphia Panel agreed that clinical importance be defined as an improvement of 15% or more relative to a control (see article titled "Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). Grade A or B recommendations were required to demonstrate both clinical importance and statistical significance.
The Philadelphia Panel EBCPGs for the management of cervical pain are mainly in agreement with previous and recent EBCPGs7 for neck pain described in Appendix 1. The Philadelphia Panel EBCPGs for cervical pain have the advantage that they were developed based on a systematic grading of the evidence determined by an expert, transdisciplinary panel and the evidence was derived from systematic reviews and meta-analyses using the Cochrane Collaboration methodology.64 The finalized guidelines were circulated for feedback from practitioners to verify their applicability and ease of use for practicing clinicians. This rigorous methodological procedure provides considerable credibility for rehabilitation specialists who intend to use these EBCPGs for cervical management in their daily practice.
Therapeutic Exercises
Our meta-analysis showed that proprioceptive and traditional therapeutic exercises are effective for pain relief in chronic cervical pain. No included studies considered exercises for acute or subacute conditions. In contrast to our results, 3 recent reviews concluded that there was insufficent evidence regarding therapeutic exercises for neck pain.5,32,33 Functional exercises including proprioceptive phasic exercises have been described as effective in another review.65 Types of exercise, intensity, and progression need to be clarified according to patient specific classification of physical dysfunction, needs, treatment goals, and outcomes.4,66,67
Mechanical Traction
Although 3 RCTs have been conducted in acute12 and chronic21 cervical pain, the results did not meet the criteria for a consistent clinically important benefit for intermittent traction. Static traction was not used by investigators in the included studies.
These results are mainly in concordance with previous systematic reviews for acute and chronic cervical pain management,5,32,42 even though these authors did not clearly distinguish between manual and mechanical traction. Our systematic review included patients with cervical pain with neurological signs in 1 of the 2 trials.21 Pennie et al12 did not report whether their subjects with cervical soft tissue injuries exhibited neurological signs. According to the information provided by these trials, none of the included subjects had disk involvement. Furthermore, exclusion criteria, such as acute strain, sprains, presence of inflammation, or joint instability of the spine, were not consistently reported in the primary trials. The proposed clinical indication for static or sustained traction is the presence of a nuclear disk protrusion.68,69 Thus, the use of intermittent traction by Goldie et al21 is questionable.70 This point shows the importance of identifying homogenous subgroups of patients with neck pain based on precise differential physical dysfunction diagnostic classes, such as nerve root adhesion, hypomobility dysfunction, and sacroiliac hypermobility.71 The effectiveness of intermittent mechanical traction was not demonstrated by the existing studies, mainly due to the inclusion of patients with neurological signs, which required more likely a mechanical traction in static mode. Other confounding variables such as neck position, traction force, duration of traction, angle of pull, and position of the patient need to be further investigated.72
Therapeutic Ultrasound
Our systematic review found no evidence of clinically important benefit of therapeutic ultrasound for chronic cervical syndrome.28 No studies were found on therapeutic ultrasound for acute neck conditions. Other research work is obviously needed for cervical syndrome at different stages of the condition. The Philadelphia Panel recommendation (level II, grade C) disagrees with the QTF quidelines,6 which recommended therapeutic ultrasound for muscle spasm and pain relief, though no scientific evidence was described. The BMJ7 guidelines did not evaluate therapeutic ultrasound.
The single trial available was of medium quality (3 out of 5 on the Jadad scale10,11). The type of therapeutic ultrasound was continuous in this study.28 It is usually recommended for chronic pain,73 but does not seem to be effective. Other confounding variables such as randomization method, characteristics of the device, size of the head, and study duration (1 week) may have contributed to the lack of treatment effect of therapeutic ultrasound in this trial.35,37 These results concur with a previous systematic review,35 even though it was conducted for various musculoskeletal conditions.
TENS
The Philadelphia Panel recommended that there was poor evidence to include or exclude TENS for acute neck pain, based on the lack of measured effect in one RCT.14 These results agree with other systematic reviews of cervical pain.5,32 The Philadelphia Panel EBCPGs (level I, grade C) are in agreement with QTF guidelines,6 which do not recommend TENS for cervical pain. However, the QTF guidelines6 do not differentiate between electroanalgesia and TENS. The BMJ guidelines7 did not evaluate TENS for pain relief. Specific therapeutic application of TENS is of key importance. Vibratory stimulation has been recommended as part of the TENS application.7476 Nordemar et al14 did not mention the use of vibratory stimulation in their study. There is a need for strict and rigorous RCTs of TENS using combined vibratory stimulation. Identification of the appropriate target clientele may be also an important factor.77
EMG Biofeedback, Therapeutic Massage, Thermotherapy, Electrical Stimulation, and Combined Rehabilitation Interventions
There are many studies in the scientific literature showing the positive physiological effects of these interventions.7882 Despite the physiological effects, either there are no clinical data or there is insufficient clinical information on the effectiveness of EMG biofeedback, therapeutic massage, thermotherapy, electrical stimulation, and combined rehabilitation interventions for acute and chronic cervical syndrome.8385
The Philadelphia Panel was unable to make a clinical recommendation regarding these specific interventions. This is in agreement with BMJ7 and QTF6 guidelines, which did not evaluate these interventions.
Overall
The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed prospective RCTs. An enormous research effort should be done in conducting RCTs for almost each rehabilitation interventions for acute or chronic cervical syndrome. This situation is critical compared with the neck pain research area. Future research in physical therapy should also adopt rigorous methods such as the use of an appropriate placebo (and double-blind procedure), adequate randomization, homogeneous sample of patients based on rigorous selection and diagnosis criteria, and adequate sample size to detect clinically important differences with confidence.
| CONCLUSION |
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| Appendix 1 |
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| Appendix 2 |
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| Footnotes |
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Acknowledgments: Summer students: Sarah Milne, Michael Saginur, Marie-Josée Noël, Mélanie Brophy, Anne Mailhot
* Oxford, England: The Cochrane Collaboration, 2000. ![]()
| References |
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