Table 4: PICO questions, recommendations, definitions of interventions, supporting evidence and comments regarding recent onset low back pain

PICO 1. Should patients with recent onset low back pain be advised to stay active as compared to rest?

↑ Consider offering patients with recent onset LBP advice
Definition: Staying active was defined as maintaining usual levels of daily activity, including work, despite pain. Advice should include information regarding benefits of staying active (including continued work participation), the potential harm of inactivity, and information regarding gradual increase in levels of activity. Advice should be given individually and in dialogue with the patient

Included studies: For advice to stay active, we identified four randomised studies. [25-28] Advice to stay active was compared to bed rest [26, 27], advice about activity within pain limits [28], and no advice [25]

Primary outcomes: Two studies showed a small, statistically significant effect in favour of staying active on short term pain intensity and activity limitation [15, 29]

Comment: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate The working group agreed that the overall positive effects of staying active outweigh the potential harmful effects, which led to a recommendation in favour of advice to stay active

PICO 2. Should patients with recent onset low back pain be offered individualised patient education in addition to usual care?

↑ Consider offering individualised patient education in addition to usual care in patients with recent onset low back pain and the ability to increase self-efficacy
Definition: Patient education was defined as education regarding health literacy, competencies, and adaptation of behaviour. [30] Patient education should consist of reassurance facilitated by elements of cognitive behavioural therapy. Reassurance was defined as a process taking place during the interaction between the clinician and the patient, during which information, instruction, or persuasions are exchanged with the purpose of reducing patients worries and fears of illness, and where recommendations are translated into action in daily life [31, 32]

Included studies: We identified nine RCTs published in 10 papers. [25, 29, 33–40] Patient education consisted of dialogue only [33–35], or dialogue in combination with exercise therapy. [25, 29, 36–40] Patient education was compared to usual care in the form of usual general practice [33–35, 37], advice [29, 36], manual therapy [38], and exercise therapy [25, 39]

Primary outcomes: Six papers reported on the primary outcomes [25, 34, 36–39]. We saw a small, statistically significant improvement in short term fear-avoidance in favour of patient education in addition to usual care compared with usual care alone. [36] No difference in effect was observed in short term pain intensity [25, 34, 36–39]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, imprecise effect estimate, only one study (short term fear-avoidance); and small sample size (short term fear-avoidance)

In addition to the recommendation, the working group agreed that individual patient education should be offered specifically to patients who are worried about their LBP, show signs of fear-avoidance or passive behaviour. The intervention should only be offered to patients who are motivated, are able to change their level of selfefficacy, and be based on a patient-centred dialogue.

PICO 3. Should patients with recent onset low back pain be offered targeted interventions compared to usual (non-targeted) care?

√ It is not good practice to routinely offer targeted treatment in patients with new onset LBP in addition to usual care over usual care, as the effect is unknown
Definition: The working group operationalized targeted treatment, as treatment targeting subgroups of patient with similar pre-identified, modifiable prognostic factors

Included studies: We identified six RCTs. [34, 41–45] Four studies [41–44] grouped patients according to physical prognostic factors and evaluated the effect of physical interventions (spinal manipulation or exercises). Two studies [34, 45] grouped according to psychological factors or duration of symptoms, and evaluated the effect of cognitive behaviour therapy or graded activity

Comments: All six studies compared the intervention to a non-matched intervention, and were considered to have low risk of bias, but none were designed or had adequate power to address the effect of targeting treatment to subgroups (primary outcomes: short term pain intensity and activity limitations). The working group also found that the studies were too heterogeneous in terms of definitions of subgroups and interventions. Thus, the recommendation is based on consensus

The working group further recommends that clinicians consider psychosocial aspects of LBP, as it may lead to identification of patients with specific needs

PICO 4. Should patients with recent onset low back pain be offered routine imaging (MRI or X-ray) compared to no imaging?

↓ Do not routinely offer imaging (MRI or X-ray) to patients with recent onset LBP, as the evidence does not support a positive effect
Definition: Routine use of either lumbar magnetic resonance imaging or conventional X-ray

Included studies: We identified four randomised studies. [46–49] The effect of routine MRI was evaluated in two studies [46, 47] and x-ray in two studies [48, 49] combined with usual care in all four studies. This was compared to imaging on specific indication or lack of improvement, [47–49] and to a delayed information about findings [46]

Primary outcomes: Only one papers reported on the primary outcomes. [46] Long term sick leave was not statistically different in the two groups in one study [46]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, no reporting of the primary outcome health care utilizstion, only one study, and risk of bias

The working group agreed that imaging without indications of serious underlying conditions does not improve clinical outcomes. Further, the potential harm (i.e., radiation exposure and risk of labelling patients with diagnoses that might not be the actual cause of their pain) outweigh the potential positive effects, which led to a recommendation against routine imaging

PICO 5. Should patients with recent onset low back pain be offered spinal manual therapy in addition to usual care?

↑ Consider offering patients with recent onset LBP spinal manual therapy in addition to usual care
Definition: Spinal manual therapy was defined as any manual technique that moves one or more joints within normal ranges of motion and aims at improving spinal joint motion or function, i.e., any mobilisation or spinal manipulation technique

Included studies: Four studies were included [50–53], all of which evaluated spinal manipulation as an add-on to usual care. No studies evaluated spinal mobilisation. This was compared to four different usual care packages; ultrasound [52], myofascial release [51], information and paracetamol [53], or information, muscle relaxants or low dose opioids, and physiotherapy [50]

Primary outcomes: We observed a small, statistically significant effect in favour of manual therapy on short term pain intensity [50–53], but no difference in effect on short term activity limitations [50–53]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and inconsistent results

PICO 6. Should patients with recent onset low back pain be offered supervised exercise in addition to usual care?

↑ Consider offering patients with recent onset LBP supervised exercise in addition to usual care
Definition: Supervised exercise was broadly defined as exercises or physical activity, which were aimed directly at the back or general health and fitness, e.g., back-specific strengthening, stretching, motor control exercise or mobilising exercises, and cardiovascular training. The exercises had to be adapted to the individual, be progressive as per patient improvement, and be delivered by a trained healthcare professional

Included studies: Seven RCTs reported in eight papers [25, 36, 54–59] were included. The intervention consisted of either general strengthening, coordination and mobility exercises [25, 36, 54–56], directional exercise [57, 59], and endurance training of spinal musculature. [58] This was compared to usual care consisting of advice and paracetamol as needed [54, 55, 57–59], standard GP care [36, 56], and a dialogue based consultation. [25]

Primary outcomes: Four papers reported on the primary outcomes [25, 54, 56, 57]. We did not observe differences in effects in long term pain intensity [25, 54, 56] or long term activity limitations [25, 56, 57]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate

A recommendation in favour of the intervention was formulated based on the observation that there was a trend in all the included studies in favour of supervised exercise. This uniform trend was neither statistically significant nor clinically relevant, but a positive effect of supervised exercise cannot be conclusively dismissed. In addition, it was emphasised that exercise has a potential positive effect on the patients’ general health, it may prevent recurrent episodes, and serious adverse events are rare

PICO 7. Should patients with recent onset low back pain be offered acupuncture in addition to usual care?

↓ Do only offer patients with recent onset LBP acupuncture in addition to usual care after careful consideration, as the effect is uncertain
Definition: Acupuncture was defined as any treatment that involves penetrating the skin with fine needles without the use of injection of substrates, i.e., as in concordance with traditional eastern medicine or in the form of dry-needling

Included studies: We included two RCTs. [60, 61] One study evaluated traditional Chinese acupuncture [60] and one evaluated dry-needling. [61] Both compared the intervention with usual care defined as information and advice regarding usual activity

Primary outcomes: A small, statistically significant effect in favour of acupuncture intervention was found on short term pain intensity. [60, 61] No difference in effect was seen on short term activity limitations [60, 61]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate, and small sample size

A recommendation against the intervention was formulated based on the observations that the effect of the intervention was not clinically relevant regarding short term pain intensity, there were no differences in effects regarding short and long term function, a possible negative effect regarding sick leave, and an overall very weak evidence base

PICO 8. Should patients with recent onset low back pain be offered paracetamol in addition to usual care?

↓ Do only offer patients with recent onset LBP paracetamol in addition to usual care after careful consideration, as the evidence points towards no short-term effect
Definition: Oral paracetamol taken between 2 and 21 days at an equivalent dose of 2000–4000 mg/d

Included studies: One RCT was identified. [62] The intervention consisted of 4 weeks of paracetamol 3990 mg/day in addition to usual care. This was compared to usual care alone, defined as placebo plus advice and information.

Primary outcomes: There was no difference in effects using short term pain intensity, short term activity limitations, or serious adverse events [62]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect and only one study eligible

PICO 9. Should patients with recent onset low back pain be offered opioids in addition to usual care?

↓ Do only offer patients with recent onset LBP opioids in addition to usual care after careful consideration, as the evidence points towards no short-term effect
Definition: Oral opioids taken between 1 and 14 days at an equivalent dose of 50–100 mg 4 times daily for tramadol or 10 mg maximum every 4 h for morphine.

Included studies: We identified one RCT. [63] The intervention consisted of 1–2 tablets of 5 mg oxycodone combined with 325 mg of acetaminophen every 8 h in addition to usual care. The intervention was compared to placebo plus usual care defined as 500 mg of naproxen twice daily plus advice regarding exercises, heat, cold, physiotherapy, massage, and acupuncture [63]

Primary outcomes: There was no difference in effect on short term activity limitations [63]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, only one study eligible, and no reporting of the primary outcomes short term pain intensity and serious adverse events

PICO 10. Should patients with recent onset low back pain be offered Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in addition to usual care?

↓ Do only offer patients with recent onset LBP NSAIDs in addition to usual care after careful consideration, as the evidence points towards no short-term effect
Definition: Oral ibuprofen (1200–1800 mg/d) or naproxen (500–1000 mg/d) taken between 5 and 14 days

Included studies: One RCT was identified. [53] The intervention consisted of 50 mg of oral diclofenac twice daily until the patient was pain free or no more than 4 weeks in combination with usual care. This was compared to placebo and usual care defined as advice and 1 g of paracetamol four times a day. Both groups also received deactivated ultrasound

Primary outcomes: There were no differences in effects on short term pain intensity and short term activity limitations [53]

Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, only one eligible study, and no reporting of the primary outcome serious adverse events

√ = Consensus recommendation
↓ = Weak recommendation against
↑ = Weak recommendation for.
See Tables 1 and 2 for definitions of level of evidence

Table 4: PICO questions, recommendations, definitions of interventions, supporting evidence and comments regarding recent onset low back pain

PICO 1. Should patients with recent onset low back pain be advised to stay active as compared to rest? ↑ Consider offering patients with recent onset LBP advice		Definition: Staying active was defined as maintaining usual levels of daily activity, including work, despite pain. Advice should include information regarding benefits of staying active (including continued work participation), the potential harm of inactivity, and information regarding gradual increase in levels of activity. Advice should be given individually and in dialogue with the patient Included studies: For advice to stay active, we identified four randomised studies. [25-28] Advice to stay active was compared to bed rest [26, 27], advice about activity within pain limits [28], and no advice [25] Primary outcomes: Two studies showed a small, statistically significant effect in favour of staying active on short term pain intensity and activity limitation [15, 29] Comment: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate The working group agreed that the overall positive effects of staying active outweigh the potential harmful effects, which led to a recommendation in favour of advice to stay active

PICO 2. Should patients with recent onset low back pain be offered individualised patient education in addition to usual care? ↑ Consider offering individualised patient education in addition to usual care in patients with recent onset low back pain and the ability to increase self-efficacy		Definition: Patient education was defined as education regarding health literacy, competencies, and adaptation of behaviour. [30] Patient education should consist of reassurance facilitated by elements of cognitive behavioural therapy. Reassurance was defined as a process taking place during the interaction between the clinician and the patient, during which information, instruction, or persuasions are exchanged with the purpose of reducing patients worries and fears of illness, and where recommendations are translated into action in daily life [31, 32] Included studies: We identified nine RCTs published in 10 papers. [25, 29, 33–40] Patient education consisted of dialogue only [33–35], or dialogue in combination with exercise therapy. [25, 29, 36–40] Patient education was compared to usual care in the form of usual general practice [33–35, 37], advice [29, 36], manual therapy [38], and exercise therapy [25, 39] Primary outcomes: Six papers reported on the primary outcomes [25, 34, 36–39]. We saw a small, statistically significant improvement in short term fear-avoidance in favour of patient education in addition to usual care compared with usual care alone. [36] No difference in effect was observed in short term pain intensity [25, 34, 36–39] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, imprecise effect estimate, only one study (short term fear-avoidance); and small sample size (short term fear-avoidance) In addition to the recommendation, the working group agreed that individual patient education should be offered specifically to patients who are worried about their LBP, show signs of fear-avoidance or passive behaviour. The intervention should only be offered to patients who are motivated, are able to change their level of selfefficacy, and be based on a patient-centred dialogue.

PICO 3. Should patients with recent onset low back pain be offered targeted interventions compared to usual (non-targeted) care? √ It is not good practice to routinely offer targeted treatment in patients with new onset LBP in addition to usual care over usual care, as the effect is unknown		Definition: The working group operationalized targeted treatment, as treatment targeting subgroups of patient with similar pre-identified, modifiable prognostic factors Included studies: We identified six RCTs. [34, 41–45] Four studies [41–44] grouped patients according to physical prognostic factors and evaluated the effect of physical interventions (spinal manipulation or exercises). Two studies [34, 45] grouped according to psychological factors or duration of symptoms, and evaluated the effect of cognitive behaviour therapy or graded activity Comments: All six studies compared the intervention to a non-matched intervention, and were considered to have low risk of bias, but none were designed or had adequate power to address the effect of targeting treatment to subgroups (primary outcomes: short term pain intensity and activity limitations). The working group also found that the studies were too heterogeneous in terms of definitions of subgroups and interventions. Thus, the recommendation is based on consensus The working group further recommends that clinicians consider psychosocial aspects of LBP, as it may lead to identification of patients with specific needs

PICO 4. Should patients with recent onset low back pain be offered routine imaging (MRI or X-ray) compared to no imaging? ↓ Do not routinely offer imaging (MRI or X-ray) to patients with recent onset LBP, as the evidence does not support a positive effect		Definition: Routine use of either lumbar magnetic resonance imaging or conventional X-ray Included studies: We identified four randomised studies. [46–49] The effect of routine MRI was evaluated in two studies [46, 47] and x-ray in two studies [48, 49] combined with usual care in all four studies. This was compared to imaging on specific indication or lack of improvement, [47–49] and to a delayed information about findings [46] Primary outcomes: Only one papers reported on the primary outcomes. [46] Long term sick leave was not statistically different in the two groups in one study [46] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, no reporting of the primary outcome health care utilizstion, only one study, and risk of bias The working group agreed that imaging without indications of serious underlying conditions does not improve clinical outcomes. Further, the potential harm (i.e., radiation exposure and risk of labelling patients with diagnoses that might not be the actual cause of their pain) outweigh the potential positive effects, which led to a recommendation against routine imaging

PICO 5. Should patients with recent onset low back pain be offered spinal manual therapy in addition to usual care? ↑ Consider offering patients with recent onset LBP spinal manual therapy in addition to usual care		Definition: Spinal manual therapy was defined as any manual technique that moves one or more joints within normal ranges of motion and aims at improving spinal joint motion or function, i.e., any mobilisation or spinal manipulation technique Included studies: Four studies were included [50–53], all of which evaluated spinal manipulation as an add-on to usual care. No studies evaluated spinal mobilisation. This was compared to four different usual care packages; ultrasound [52], myofascial release [51], information and paracetamol [53], or information, muscle relaxants or low dose opioids, and physiotherapy [50] Primary outcomes: We observed a small, statistically significant effect in favour of manual therapy on short term pain intensity [50–53], but no difference in effect on short term activity limitations [50–53] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and inconsistent results

PICO 6. Should patients with recent onset low back pain be offered supervised exercise in addition to usual care? ↑ Consider offering patients with recent onset LBP supervised exercise in addition to usual care		Definition: Supervised exercise was broadly defined as exercises or physical activity, which were aimed directly at the back or general health and fitness, e.g., back-specific strengthening, stretching, motor control exercise or mobilising exercises, and cardiovascular training. The exercises had to be adapted to the individual, be progressive as per patient improvement, and be delivered by a trained healthcare professional Included studies: Seven RCTs reported in eight papers [25, 36, 54–59] were included. The intervention consisted of either general strengthening, coordination and mobility exercises [25, 36, 54–56], directional exercise [57, 59], and endurance training of spinal musculature. [58] This was compared to usual care consisting of advice and paracetamol as needed [54, 55, 57–59], standard GP care [36, 56], and a dialogue based consultation. [25] Primary outcomes: Four papers reported on the primary outcomes [25, 54, 56, 57]. We did not observe differences in effects in long term pain intensity [25, 54, 56] or long term activity limitations [25, 56, 57] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate A recommendation in favour of the intervention was formulated based on the observation that there was a trend in all the included studies in favour of supervised exercise. This uniform trend was neither statistically significant nor clinically relevant, but a positive effect of supervised exercise cannot be conclusively dismissed. In addition, it was emphasised that exercise has a potential positive effect on the patients’ general health, it may prevent recurrent episodes, and serious adverse events are rare

PICO 7. Should patients with recent onset low back pain be offered acupuncture in addition to usual care? ↓ Do only offer patients with recent onset LBP acupuncture in addition to usual care after careful consideration, as the effect is uncertain		Definition: Acupuncture was defined as any treatment that involves penetrating the skin with fine needles without the use of injection of substrates, i.e., as in concordance with traditional eastern medicine or in the form of dry-needling Included studies: We included two RCTs. [60, 61] One study evaluated traditional Chinese acupuncture [60] and one evaluated dry-needling. [61] Both compared the intervention with usual care defined as information and advice regarding usual activity Primary outcomes: A small, statistically significant effect in favour of acupuncture intervention was found on short term pain intensity. [60, 61] No difference in effect was seen on short term activity limitations [60, 61] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, risk of bias, and imprecise effect estimate, and small sample size A recommendation against the intervention was formulated based on the observations that the effect of the intervention was not clinically relevant regarding short term pain intensity, there were no differences in effects regarding short and long term function, a possible negative effect regarding sick leave, and an overall very weak evidence base

PICO 8. Should patients with recent onset low back pain be offered paracetamol in addition to usual care? ↓ Do only offer patients with recent onset LBP paracetamol in addition to usual care after careful consideration, as the evidence points towards no short-term effect		Definition: Oral paracetamol taken between 2 and 21 days at an equivalent dose of 2000–4000 mg/d Included studies: One RCT was identified. [62] The intervention consisted of 4 weeks of paracetamol 3990 mg/day in addition to usual care. This was compared to usual care alone, defined as placebo plus advice and information. Primary outcomes: There was no difference in effects using short term pain intensity, short term activity limitations, or serious adverse events [62] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect and only one study eligible

PICO 9. Should patients with recent onset low back pain be offered opioids in addition to usual care? ↓ Do only offer patients with recent onset LBP opioids in addition to usual care after careful consideration, as the evidence points towards no short-term effect		Definition: Oral opioids taken between 1 and 14 days at an equivalent dose of 50–100 mg 4 times daily for tramadol or 10 mg maximum every 4 h for morphine. Included studies: We identified one RCT. [63] The intervention consisted of 1–2 tablets of 5 mg oxycodone combined with 325 mg of acetaminophen every 8 h in addition to usual care. The intervention was compared to placebo plus usual care defined as 500 mg of naproxen twice daily plus advice regarding exercises, heat, cold, physiotherapy, massage, and acupuncture [63] Primary outcomes: There was no difference in effect on short term activity limitations [63] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, only one study eligible, and no reporting of the primary outcomes short term pain intensity and serious adverse events

PICO 10. Should patients with recent onset low back pain be offered Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in addition to usual care? ↓ Do only offer patients with recent onset LBP NSAIDs in addition to usual care after careful consideration, as the evidence points towards no short-term effect		Definition: Oral ibuprofen (1200–1800 mg/d) or naproxen (500–1000 mg/d) taken between 5 and 14 days Included studies: One RCT was identified. [53] The intervention consisted of 50 mg of oral diclofenac twice daily until the patient was pain free or no more than 4 weeks in combination with usual care. This was compared to placebo and usual care defined as advice and 1 g of paracetamol four times a day. Both groups also received deactivated ultrasound Primary outcomes: There were no differences in effects on short term pain intensity and short term activity limitations [53] Comments: The level of evidence was downgraded due to lack of a clinically relevant effect, only one eligible study, and no reporting of the primary outcome serious adverse events

√ = Consensus recommendation ↓ = Weak recommendation against ↑ = Weak recommendation for. See Tables 1 and 2 for definitions of level of evidence