Clinical trial NCT04320654: Advice of Staying Active for Sub Acute Low Back Pain
Official title: Will Patients With Low Back Pain Benefit From the Advice of Staying Active
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: different groups each will receive specific intervention at the same time
Primary purpose: TREATMENT

Brief summary: The variabilities in the management approaches for patients with LBP reflect uncertainty about the optimal approach. Therefore, there is a need for the implementation of early treatment strategies relying on an evidence-based knowledge to treat the problems and reduce the risk for recurrence and chronicity of LBP.

Advice is considered as the 'first in line' for the treatment of patients with LBP and is recommended in all international guidelines, yet it is under-utilized by the general practitioners. The current evidence in favor for the advice of staying active for patients with LBP is limited, with small or no benefits in pain relief, functional improvement or sick leave compared to rest in bed. Consequently, there is a huge gap between the evidence and practice.

So, the current study aimed at filling this gap and expanding the previous findings by investigating the effect of the advice of staying active on the level of perceived pain, physical activity level, postural control and functional disability in patients with low risk LBP (with a total score of three or less based on the STarT Back Tool score).

Detailed description: In spite of the great effort, LBP remains a significant burden on the society and can cause a disturbing impact on the functional ability during the productive years of the individuals. It is important to find pragmatic treatments that not only reduce the pain, but also decrease the disability. Activity monitoring in real life has the potential to change our concept of outcomes, and as a result, expand our ideas about the appropriateness of the interventions in rehabilitation.

The international guidelines vary but agree on advising patients with LBP to remain physically active. The National Institute for Clinical Excellence (NICE)'s updated guideline on the LBP recommends encouraging people to continue with their normal activities as far as possible. NICE found that there were no randomized controlled trials (RCTs) (which are the best way of investigating the efficacy of a treatment) that compared the effect of the advice of staying active with no advice or the advice to rest.

Despite the guidelines, it was reported that many health care providers are still too restrictive and believe that LBP requires some avoidance of activities and to remain off- work. Many general practitioners do not give advice on daily activities to patients with back pain and there is confusion about what constitutes an effective advice. Only 12% of the physiotherapists identify correctly the guidelines, and most of them do not agree with these guidelines regarding the return to work or activity. Investigating the benefit of the advice of staying active and different active intervention programs in patients with low risk NSLBP may help in developing recommendations for the physiotherapists responsible for reviewing exercise protocols for patients with LBP.

Therefore, the improvement of the primary care management of patients with LBP has the potential to reduce the long-term effects of back pain, including persistent disabling symptoms, low quality of life, and reduced capacity to work. The advice of staying active may not only be a treatment to improve the recovery from LBP, but also an opportunity to promote physical activity for other health benefits, such as improved cardio-metabolic function, blood pressure, and reduced body fatness.

Eligibility criteria: Inclusion Criteria:

* Patients will be included if they are between 18 - 65 years of age
* able to stand and walk without assistance.
* Patients will also be included if they have a history of non specific low back pain classified as low risk of poor outcome with a total score of three or less based on the STarT Back Tool score (Hill et al., 2008).
* The back-pain episode is subacute

Exclusion Criteria:

* Patients will be excluded if they have any neurological disease or balance deficits due to vestibular disorders, such as vertebrobasilar insufficiency and visual disorders,
* systemic infection,
* current pregnancy,
* severe musculoskeletal deformity (scoliosis or kyphosis),
* injury to the lower extremity that would interfere with testing or a history of any surgery in the three months prior to testing.
* Patients will also be excluded if they have pain below the knee consistent with a disc herniation, presence of neurological signs, serious spinal complications (e.g., vertebral fracture, tumor or infection),
* spinal stenosis,
* confounding conditions such as extreme obesity, severe scoliosis, significant anatomical leg length inequality, previous spinal surgery.

Primary outcomes:
measure: level of perceived pain by Visual analogue scale
timeFrame: six weeks
Secondary outcomes:
measure: number of steps
timeFrame: six weeks
Other outcomes:
Locations:
Study officials:
References: