Clinical trial NCT05838040: General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP
Official title: General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP: A Crossover Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PURPOSE: To evaluate the effectiveness of adding transversus abdominis contraction to general exercises to treat patients with nonspecific acute low back pain.

BACKGROUND: Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable; thus, many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. Motor control exercises, which advocate the contraction of the TrA have shown some efficacy for patients with chronic low back pain. However, the validity of this strategy for patients with acute LBP is unclear.

HYPOTHESES: there will be no significant effect of adding transversus abdominis contraction to general exercise than general exercise alone in patients with non-specific acute low back pain.

RESEARCH QUESTION: Is there a statistically significant effect of adding transversus abdominis contraction to general exercise on outcomes of patients with non-specific acute low back pain?


Eligibility criteria: Inclusion Criteria:

1. Individuals of both sexes
2. Aged between 18 and 50 years
3. Acute nonspecific low back pain according to The most recent guidelines for the diagnosis and management of NSLBP come from the American College of Physicians and were published in 2017. According to these guidelines, the diagnosis of acute NSLBP should be made based on the following criteria:

Acute onset of low back pain, defined as pain lasting for less than 12 weeks No specific identifiable cause of the pain (e.g., infection, malignancy, fracture, inflammatory disorder) No radicular symptoms (e.g., pain radiating down the leg) No significant neurological deficits or findings on physical examination (e.g., loss of reflexes or muscle strength)

Exclusion Criteria:

1. Serious low back pathology
2. Contraindications to exercise therapy
3. Neurological signs (leg weakness)
4. Specific spinal pathology (e.g., malignancy, or inflammatory joint or bone disease)
5. Prior back surgery

Primary outcomes:
measure: Pain intensity via numeric pain rating scale
timeFrame: Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
Secondary outcomes:
measure: Pain Pressure Threshold
timeFrame: Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
measure: Disability
timeFrame: Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
measure: Global Perception Effect
timeFrame: changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: