Advice of Staying Active for Sub Acute Low Back Pain

NCT04320654 | Unknown DMC

• 1 other identifier: 5402
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• level of perceived pain by Visual analogue scale

  The Visual analogue scale will be used for measuring the pain intensity the scale ranges from 0 to 10 where 0 means no pain and 10 means severe intolerable pain.

  six weeks

Secondary Outcomes (1)

• number of steps

  six weeks

Study Arms (5)

advice of staying active

EXPERIMENTAL

The patients will be advised to stay as physically active as possible and continue their everyday activities as normally as possible.

Other: exercise

walking program

EXPERIMENTAL

Patients will be encouraged to go about their normal daily activities. At week one, patients will be asked to familiarize themselves with wearing the pedometer and recording their daily steps in a walking diary for the subsequent 7 days. The patients will return to see the physiotherapist at the end of week one to discuss any issues with the program, pedometer or recording of desired information. A step target for week two will be agreed between the physiotherapist and the patient by referring to the mean daily step count recorded at baseline, and the average step count calculated from the walking diary

Other: exercise

Backward walking

EXPERIMENTAL

All patients will be instructed to walk at their desired pace 3 days per week with a steady rhythm. The duration of each training session will initially be 15 minutes and will gradually increase, and finally reach 25 minutes, for every session (Hao Chen, 2011). There will be no constraint or indication about head and trunk position during backward training

Other: exercise

Targeted home-based hip exercise

EXPERIMENTAL

Patients who will be assigned in this group will perform a hip exercise program for six weeks, three times / week to ensure an adequate recovery between exercise sessions (appendix V). The strengthening exercises will focus on strengthening the gluteus maximus (GMax), gluteus medius (GMed), gluteus minimus (GMin) and short hip external rotator muscles (Distefano et al., 2009).

Other: exercise

control group

NO INTERVENTION

The patients will not be given any intervention and will be asked to come after 6 weeks for re-assessment

Interventions

exercise OTHER

The aim of this intervention is to increase patients average daily step count. The walking program is a behavior change intervention in which the pedometer will be used as a tool to help the patients monitor their activity levels.

Backward walking; Targeted home-based hip exercise; advice of staying active; walking program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: different groups each will receive specific intervention at the same time

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: April 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2022
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share