Manipulation for Low Back Pain
Clinical Prediction Rule
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Low back pain is a common ailment treated among the United States population. The condition can be defined as the pain and discomfort felt “below the costal margin and above the inferior gluteal folds.”1 The condition is most commonly caused by overuse, affecting ligaments joints and muscles, pressure on nerve roots, and compression fractures. 2 Leg pain is commonly associated with low back pain, and usually coincides with nerve root compression injuries. Because this article will be focused on manipulations for low back pain, fractures will not be discussed further since fracture is a contraindication to aggressive manual therapy.


Low back pain usually requires a cross-disciplinary approach of individuals in various specialties within the medical community. Whether it be patients of family physicians, surgeons or physical therapists, low back pain patients are a large and growing population.3 A 2009 study found that over the previous 14 years, the prevalence of impairing low back pain rose from 3.9% to 10.2%.3 This rise in patient population has implications not only for providers, but also for the economy. While the economic burden low back pain implements on health care costs has been established and verified, exact numbers have yet to be estimated. 4 Not only do insurance companies pay the price, but employers are suffering a loss in productivity as well. It has been found that low back pain is the second leading cause of sick leave in the United States. 1


What’s a clinical prediction rule?
Because of its prevalence and societal implications, the development of a clinical prediction rule surrounding low back pain is becoming increasingly important. To begin, a clinical prediction rule serves as a tool to health care providers in determining accurate diagnosis and/or prognosis of a patient. 5 In essence, the tool quantifies specific factors such as lab results, history and physical exam that would contribute in predicting the outcome of a patient. 5 They aid physicians in accurately and consistently determining the appropriate plan of care based upon a patient’s clinical presentation. For example, a clinical prediction rule can serve to establish “pretest probability, provide screening tests for common problems, and estimate risk.” 5


Example of CPR for Pulmonary Embolism
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Benefits of CPR for low back pain manipulation
One could see why the development of such rules and guidelines would be deemed necessary for a condition as widespread as low back pain. The development of clinical predication rules is not a simple task. It requires three general steps including the creation of the rule itself, validation of the rule, and determining its impact on clinical conduct. 5


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In the physical therapy world, one such development for low back pain could prove very useful. This is because there are countless factors playing into the ultimate condition of low back pain. For example, the onset of pain (insidious versus abrupt) may play an important role in determining the appropriate treatment of the patient. These two factors may respond very differently to treatments, or require slightly adjusted protocols. This article aims to explore the frequently used treatment, spinal manipulation, within the physical therapy clinic. A manipulation is taking a joint to its passive range of motion limit, and providing a high-velocity low-amplitude thrust. More specifically, through the investigation of recent research in the field, the paper hopes to discover clinical prediction rules that will aid in clinical decision making with regards to manipulation and low back pain.

The use of lumbar spine manipulation technique by physical therapists in patients who satisfy a clinical prediction rule: a case series

A study published in the Journal of Orthopedic Sports Physical Therapy by Cleland et al., tested a Clinical Prediction Rule (CPR) that aims to identify patients with acute low back pain (LBP) most likely to benefit from spinal manipulation therapy (SMT).

The CPR includes:
1) Current episode is within 16 days of onset
2) No neurologic symptoms below the knee
3) At least 1 hypomobile lumbar spinal segment
4) At least one hip with over 35 degrees of internal rotation
5) A Fear-Avoidance Beliefs Questionnaire (FABQ) score of less than 196.

A positive response was defined as greater than or equal to a 50% reduction in self-reported disability after two sessions.

The researchers compared two types of manipulations:

1)Supine high-velocity low amplitude (HVLA) thrust targeting the lumbosacral spine
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Supine Manipulation Video


2) Side-lying HVLA thrust of the pelvis in an anterior direction
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Side-lying Manipulation Video

Contraindications for manipulations in this study, as well as most others, include:

Tumor, fracture, infection, rheumatoid arthritis, osteoporosis, prolonged corticosteroid use, evidence of nerve root involvement, bilateral neurologic symptoms in lower extremities, saddle anesthesia, loss of bladder or bowel function, unexplained weight loss, and current pregnancy6.

The median duration of symptoms in this study was 19 days. The therapist randomly performed one of the two manipulations on day 1, and followed it with a posterior pelvic tilt exercise. On the second day, within the first week, the therapist did the other manipulation, and followed it with the same exercise. Ninety-two percent of patients who met 4/5 criteria of the CPR had a positive result within 2 treatments (1 week)6. This suggests that the type of manipulation does not matter, but that success is related to meeting the CPR. This does not prove that manipulation causes relief of LBP, but it suggests a CPR can find patients with a high chance of experiencing a quick improvement of their LBP symptoms. It also allows the physical therapist to choose a manipulation they, and their patient, feels most comfortable with.

A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely to Benefit from Spinal Manipulation: A Validation Study
Another study used the same CPR. This one, by Childs et al., compared one type of manipulation plus exercise to an exercise only group. They performed 2 manipulations the first week, followed by 1 per week for the next 3 weeks. The manipulations were always followed by exercise.

-Forty-four percent of the manipulation group, compared to 11.5% of the exercise group, had a positive result after week one.
-That increased to 63% and 36% after 4 weeks7.
-This study showed a 44% pretest success probability, and with a 13.2 positive likelihood ratio, the posttest probability increased to 92 percent7.

“Positive likelihood ratios greater than 10 generate large and often conclusive shifts in probability of success.”8 This shows manipulation can be an effective intervention for those that are positive for the CPR.

A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation
A systematic review of 14 articles done by Dagenais et al., concluded SMT is effective for pain reduction in the short, intermediate, and long term9. Pain reduction was substantial in the first 1 to 2 weeks, and peaked within 3-4 weeks. No studies showed SMT was less effective than any other interventions at any time point9. They also concluded that 20 treatments had no advantages over 5-10 treatments. Spinal manipulation therapy can be a quick, cost effective, and successful intervention for patients with low back pain.

Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial
In a study by M. Hancock, the external validity of the CPR by Childs et al is questioned. Methodology literature on developing clinical prediction rules states that the rule must apply in different settings, with different patients, and a range of clinicians before the generalisability of the rule can be established.
In Childs' study, treatment involved a single, non-specific manipulation on all patients no matter what they presented with. Also, this CPR was tested in participants recruited primarily from US Air Force facilities. Therefore, the aim of Hancock’s study was to independently evaluate whether the previously mentioned clinical prediction rule could be generalized to a different setting, one that includes patients receiving SMT from physiotherapists.

All the patients involved in this study had:
  • low back pain lasting less than 6 weeks
  • pain in the area between the 12th rib and buttock crease
  • pain moderate and moderately disabling

Patients were divided into 4 groups:
  • placebo SMT + active diclofinac (a non-steroidal anti-inflammatory drug)
  • placebo SMT + placebo diclofinac
  • active SMT + active diclofinac
  • active SMT + placebo diclofinac.

Participants who were in the group receiving SMT were seen by physiotherapists who regularly use SMT either 2 or 3 times per week over 4 weeks. The placebo group's therapy involved detuned pulsed ultrasound.

Each participant’s status on the clinical prediction rule was determined using identical criteria that the Childs study used. Participants who met 4 or more of the 5 criteria were classified as positive on the rule.
Criterion
Definition of positive
Duration of current episode
<16 days
Extent of distal symptoms
No symptoms distal to the knee
FABQ work subscale score
<19 points
Segmental mobility
≥1 hypomobile segment in the lumbar spine
Hip internal rotation range of motion
≥1 hip with >35° of internal rotation range of motion
Eur Spine J. 2008 July; 17(7): 936–943.Published online 2008 April 22. doi: 10.1007/s00586-008-0679-9
Outcomes were pain and disability measured at 1, 2, 4, and 12 weeks.

In the end, this study found very small, non-significant difference between the SMT and placebo group. The rule did not identify those patients who were more likely to respond better to SMT. In fact, positive status on the prediction rule tended to predict better prognosis regardless of the treatment type. It was concluded that this CPR appears to not generalize to SMT as widely practiced by physiotherapists, which limits its usefulness in clinical practice. The results of this study have important implications for the development of any clinical prediction rule. Rules should represent a broad validation that’s been tested in many clinical settings and in different patients12.

Patient expectations of benefit from common interventions for low back pain and effects on outcome: secondary analysis of a clinical trial of manual therapy intervention.

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Patients' expectations that they will experience improvement in their pain ranked by the proportion of agreement

In a secondary analysis by Bishop et. al., their findings strongly encourage physical therapists to implement active interventions and manual therapy such as spinal manipulative therapy. For subjects that expected manual therapy from PT and received SMT, 90% reported that their expectations for therapy were met. If subjects from the same group did not receive SMT, then only 44% had their expectations for therapy met. This is important because previous studies have indicated that meeting general expectations is associated with patient satisfaction and higher reported function. This article is relevant to this project because only subjects that fit the CPR for low back pain were given SMT, further justifying the need for a reliable CPR for spinal manipulation for low back pain. In a systematic review by Haskins et. al., it was determined that there is little confidence in the direct application of the 25 CPRs for low back pain that were included in the study. Among the 25 unique CPRs, 15 were diagnostic, 7 prescriptive, and 3 prognostic. Although their analysis was quite extensive, encompassing 23 studies and over 7,000 unique records, they cannot say for certain that none of the CPRs involved in the study are completely useless. Further research is essential to validate the current CPRs or develop new ones.

There are many studies that show a clinical prediction rule can find patients that are likely to benefit from spinal manipulation therapy. However, for best results this should be combined with NSAIDs, patient education, and exercise. Many of these studies found that a current episode of less than 16 days is the most important variable to predict a successful outcome, so early intervention is very important8. It is currently difficult, in the state of Kansas, to see a physical therapist within 16 days because patients need to make an appointment to see a physician, be referred to therapy, and then make an appointment to see a physical therapist. Outpatient clinics in direct access states could utilize this research to encourage the public to seek early therapy interventions for the best outcomes of low back pain, including quick relief of pain, increase in function, and lower medical costs.







References

1. Vrbanić TS-L. [Low back pain--from definition to diagnosis]. Reumatizam. 2011;58(2):105-7. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22232956. Accessed March 21, 2012.

2. Anon. Causes of Low Back Pain: Lower Left and Right Back Pain. WebMD. 2011. Available at: http://www.webmd.com/back-pain/tc/low-back-pain-cause. Accessed March 21, 2012.

3. Freburger JK, Holmes GM, Agans RP, et al. The rising prevalence of chronic low back pain. Archives of internal medicine. 2009;169(3):251-8. Available at: http://archinte.ama-assn.org/cgi/content/abstract/169/3/251. Accessed March 21, 2012.

4. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. The spine journal: official journal of the North American Spine Society. 2008;8(1):8-20. Available at: http://dx.doi.org/10.1016/j.spinee.2007.10.005. Accessed March 4, 2012.

5. McGinn TG, Guyatt GH, Wyer PC, et al. Users’ guides to the medical literature: XXII: how to use articles about clinical decision rules. Evidence-Based Medicine Working Group. JAMA: the journal of the American Medical Association. 2000;284(1):79-84. Available at: http://www.ncbi.nlm.nih.gov/pubmed/10872017. Accessed March 21, 2012.

6. Cleland JA, Fritz JM, Whitman JM, Childs JD, Palmer JA. The use of lumbar spine manipulation technique by physical therapists in patients who satisfy a clinical prediction rule: a case series. Journal of Orthopedic Sports Physical Therapy. 2006;36(4):209-214. Available at http://www.ncbi.nlm.nih.gov.proxy.kumc.edu:2048/pubmed?term=16676870. Accessed March 21, 2012.

7. Childs JD, Fritz JM, Flynn TW, Irrgang JJ, et al. A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely to Benefit from Spinal Manipulation: A Validation Study. Annals of Internal Medicine; Dec 21, 2004; 141, 12. Available at http://www.ncbi.nlm.nih.gov.proxy.kumc.edu:2048/pubmed?term=15611489. Accessed March 21, 2012.

8. Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine. 2002; 27(24): 2835-43. Available at http://www.ncbi.nlm.nih.gov.proxy.kumc.edu:2048/pubmed?term=12486357 Accessed March 21, 2012

9. Dagenais S, Gay RE, Tricco AC, Freeman MD, Mayer JM. NASS Contemporary concepts in spine care: spinal manipulation therapy for acute low back pain. Spine Journal. 2010; 10(10): 918-40. Available at http://www.ncbi.nlm.nih.gov.proxy.kumc.edu:2048/pubmed?term=20869008. Accessed March 21, 2012.

10. Bishop, Bialosky, Cleland. Patient expectations of benefit from common interventions for low back pain and effects on outcome: secondary analysis of a clinical trial of manual therapy intervention. J Man Manip Ther. 2011 Feb;19(1):20-5.

11. Haskins R, Rivett DA, Osmotherly PG. Clinical prediction rules in the physiotherapy management of low back pain: a systematic review. Man Ther. 2012 Feb;17(1):9-21. Epub 2011 Jun 8.

12. Hancock, M. J., Maher, C. G., Latimer, J., Herbert, R. D., & McAuley, J. H. (2008). Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial. European spine journal: official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 17(7), 936-43. doi:10.1007/s00586-008-0679-9