Although several recent trials assessed interventions for identification and treatment of yellow flags in patients with low back pain, it is difficult to draw general conclusions about their effectiveness because of differences in the treatments (ranging from brief interventions administered by a primary care clinician to intensive, interdisciplinary interventions) and populations studied. Two higher-quality trials found brief interventions no more effective than standard practice or conventional physical therapy in patients with back pain of less than 12 weeks duration (Table 2)304, 305. One trial (n=314) found no differences through 12 months
between usual care and a minimal (20 minute) intervention aimed at identifying, providing information about, and promoting self-care of psychosocial risk factors for any outcome
including back-specific functional status (RDQ score), pain, sick leave, perceived general health (SF-36), or general practitioner visits305. The minimal intervention also failed to show a benefit
in higher-risk subgroups of patients with increased baseline psychological distress or recurrent back pain. The second trial (n=402) found no differences on back-specific functional status (ODI score), pain, time off work, depression scores, use of health care resources, or satisfaction with care after either 3 or 12 months among patients randomized to a brief pain management program (aimed at identifying psychosocial risk factors, emphasizing return to normal activity through functional goal setting, and using educational strategies to overcome psychosocial barriers to recovery as well as a tailored exercise program) versus a physical therapy intervention (with an emphasis on spinal manipulation)304 The number of physical therapy
sessions was slightly lower with the brief intervention. All patients improved regardless of which treatment they were randomized to.
Table 2. Trials of brief interventions for identifying and treating yellow flags Author, year Number of patients Duration of follow- up Main results Quality score* Hay, 2005304 n=402 12 months
Brief pain intervention vs. manual physical therapy
(results at 12 months unless otherwise noted)
ODI score, mean change from baseline: 7.8 vs. 8.1 at 3 months, p=0.755; 8.8 vs. 8.8 at 12 months, p=0.994
Overall assessment 'much better' or 'completely better' at 12 months: 68% vs. 69%
Back pain (0 to 100 scale): 78 vs. 70, p=0.401
Took time off work in last 12 months: 54% vs. 58%, p=0.45 Satisfaction with treatment (0 to 100 scale), median: 93 vs. 93
7/9
Jellema, 2005305
n=314 12 months
Minimal intervention vs. usual care
(results at 12 months unless otherwise noted)
RDQ score (0 to 24 scale): 1 vs. 1, mean difference 0.25 (- 0.77 to 1.28)
No recovery (rated recovery as slightly improved, no change, slightly worse, much worse, or very much worse): 42/132 (32%) vs. 43/156 (28%), odds ratio 1.16 (0.63 to 2.17) Sick leave due to low back pain: 8/107 (8%) vs. 9/128 (7%), odds ratio 0.69 (0.43 to 1.13)
Pain severity: mean difference 0.015 (-0.41 to 0.44)
6/9
*Excludes criteria involving blinding of patients and care providers, for maximum score of 9
Several factors could explain the lack of an effect in these two trials. In one study, patients randomized to the minimal intervention were not permitted to receive physical therapy for the first six weeks305. In addition, general practitioners randomized to the minimal intervention arm were only moderately successful in identifying psychosocial factors, and were no more effective than practitioners randomized to usual care in improving outcomes measured by psychosocial scales311. It is possible that additional training or a more intense intervention could result in
more effective treatment. In addition, targeting the intervention to high-risk patients could improve outcomes compared to treating a less selected group of patients312. These hypotheses
are supported in part by a third, small (n=70), higher-quality trial which found a more intense (including three physician evaluations and a total of up to 45 physical therapy, biofeedback/pain management, group didactic, and case manager/occupational therapy sessions),
interdisciplinary functional restoration intervention associated with improved pain and decreased disability after 12 months (Table 3) compared to usual care in patients with acute (<8 weeks) low back pain identified as being at higher risk for chronic disability using a screening tool306.
Table 3. Trials of intensive multidisciplinary functional restoration in patients at higher risk for chronic disability
Author, year
Number of patients Duration of
follow-up Main results
Quality score*
Gatchel, 2003306 n=70
12 months
Multidisciplinary functional restoration vs. usual care
Return to work at 12 months: 91% vs. 69% (p=0.027) Average number of healthcare visits: 26 vs. 29 (p=0.004) Average number of healthcare visits related to low back pain: 17 vs. 27, p=0.004
Average number of disability days due to back pain: 38 vs. 102, p=0.001
Average most “intense pain" at 12 month follow-up: 46 vs. 67, p=0.001
Average self-rated pain over last 3 months: 27 vs. 43, p=0.001 Taking opioid analgesics: 27% vs. 44%, p=0.020
6/9
*Excludes criteria involving blinding of patients and care providers, for maximum score of 9
Two other trials evaluated interventions aimed at reducing fear avoidance behaviors (Table 4). In one lower-quality trial, 240 patients with persistent low back pain and activity limitations 8 to 10 weeks after the initial visit were randomized to four sessions of an individualized fear avoidance intervention with a psychologist and physical therapists versus usual care307. The
fear avoidance intervention was superior for disability outcomes, with the proportion of patients experiencing a greater than one-third reduction in RDQ score: 28% vs. 13% at 2 months (p=0.0007) and 49% vs. 37% at 24 months (p=0.08). Average pain intensity was slightly better in patients randomized to the intervention after two months, though the difference was no longer significant at 24 months. There was no difference in SF-36 scores or ability to work, though a lower proportion of patients randomized to the fear avoidance intervention reported activity limitations due to back pain for 30 or more days after 24 months (8.5% vs. 14.3%, p=0.04). Patients randomized to the fear avoidance intervention also reported lower scores on fear- avoidance and worry rating scales. The second, smaller (n=67), higher-quality trial found no differences on the ODI scale or pain intensity after 6 months between low back pain (less than 8 weeks duration) patients randomized to fear avoidance-based physical therapy (encouraging patient to take an active role in treatment and to view back pain as common, along with a self- care booklet and graded exercise) and standard exercise308. The fear avoidance intervention
was associated with lower fear avoidance beliefs in the subgroup of patients with high baseline fear avoidance scores.
Table 4. Trials of fear-avoidance based interventions
Author, year
Number of patients Duration of
follow-up Main results
Quality score*
George, 2003308 n=67
6 months
Fear avoidance exercise program vs. standard exercise
ODI score (0 to 100), mean change: 18.0 vs. 17.1 at 4 weeks (NS), 23.9 vs. 23.0 at 6 months (NS)
Present pain intensity (0 to 10), mean change: 2.4 vs. 2.0 at 4 weeks (NS), 2.6 vs. 3.0 at 6 months (NS) Fear Avoidance Beliefs Questionnaire, Physical Activity Scale (0 to 24), mean change: 5.0 vs. 1.8 at 6 months, p=0.037
Fear Avoidance Beliefs Questionnaire, Work Scale (0 to 42), mean change: 3.1 vs. 1.9 at 6 months, p=0.352
7/9
Von Korff, 2005307 n=240
24 months
Fear avoidance intervention vs. usual care
RDQ score (0 to 24): 10.2 vs. 11.5 at 2 months, p=0.0002; 8.1 vs. 9.1 at 24 months, p=0.0078 Proportion of patients with greater than one-third reduction in RDQ score: 28% vs. 13% at 2 months, p=0.0007; 49% vs. 37% at 24 months, p=0.08 Fear-avoidance (17-68): 36.4 vs. 39.9 at 2 months, p<0.0001; 34.3 vs. 38.4 at 24 months, p=0.0001 Average pain intensity (0 to 10): 4.9 vs. 5.3 at 2 months (p=0.020); 4.3 vs. 4.6 at 24 months (p=0.115)
SF-36 social functioning and SF-36 mental health inventory: no differences
Unable to work: No differences
Unable to carry out usual activities due to back pain for 30 or more days: 24% vs. 26% at 2 months, p=0.06, 8.5% vs. 14.3% at 24 months, p=0.04
4/9
*Excludes criteria involving blinding of patients and care providers, for maximum score of 9
Harms
No trial reported harms. Costs
A cost-benefit analysis of the trial comparing an intensive, early multidisciplinary intervention in patients identified as higher risk for chronic disability calculated a net gain of $9,122, mostly related to a reduction in lost wages in the intervention group306.
Summary of evidence
• In unselected patients with acute or subacute low back pain, two higher-quality trials found no benefits after 12 months from brief interventions designed to identify and treat yellow flags compared to usual care or physical therapy with an emphasis on manipulation or mobilization (level of evidence: good).
• In patients with back pain for less than 8 weeks identified as being at higher risk for chronic disability using a screening tool, one higher-quality trial found an intensive interdisciplinary functional restoration program more effective than usual care after 12 months (level of evidence: poor).
• In patients with persistent activity limitations due to low back pain, one lower-quality trial found fear-avoidance based therapy slightly superior to usual care for back specific functional status after 24 months, though beneficial effects on pain were only short-lived (level of
evidence: poor).
• For subacute (<8 weeks) low back pain, one higher-quality trial found no difference between fear-avoidance therapy and standard physical therapy after 6 months, though fear-avoidance beliefs were decreased in the intervention group (level of evidence: fair).