Clinical trial NCT07026058: Sound Sine Wave And Standard Physiotherapy In Mechanical Low Back Pain
Official title: Effects Of Sound Sine Wave And Standard Physiotherapy On Pain, Mobility, Function And Pelvic Alignment In Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pian
Physical Therapy
Disability
Pelvic Alignment
Range of Motion
Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study design will be a randomized clinical trial (RCT). Sampling technique will be nonprobability convenience sampling. Data will be collected from KKT orthopedic spine center Lahore. Participants will be divided into 2 groups. Group A will receive Sound wave treatment protocol and standard physiotherapy treatment protocol , Group B will receive only Standard Physiotherapy treatment .Both groups will receive TENS and hot pack for 10 minutes. The inclusion and exclusion criteria will be Both gender , aged 18-45 years , Minimum 03 months chronicity of lower back pain , Clinically diagnosed with the help of tests SLR test to rule out nerve root compression or disc herniation, FABER test to rule out SI joint dysfunction ,Scobber Test to assess lumbar flexibility and mobility, Lumber quadrant test to identify pain from facet joints, Lumber extension test and Pain localized to the lumbar region, potentially radiating to the buttocks or thighs but not below the knee. The Exclusion Criteria will be Chronic systemic soft tissue and bony diseases , History of spinal trauma or fractures , Severe spinal stenosis or spondylolisthesis and Pain radiating to one or both legs, consistent with lumbar radiculopathy. The outcome measure tools will be NPRS, inclinometer, x-rays and Oswestry Disability Index (ODI) . Data will be analyzed using SPSS . Ethical Committee of Riphah International University, and informed consent will be secured from all participants.

Detailed description: Low back pain (LBP) is considered one of the most common musculoskeletal disorders that affect people of all ages around the world. In addition, LBP is becoming a burden in many developing and low-income countries due to high healthcare costs for its treatment and management. Low back pain (LBP) is defined as a pain or discomfort located below the margin of the 12th rib and above the inferior gluteal fold, with or without leg pain. Low back pain covers a spectrum of different types of pain (eg, nociceptive, neuropathic and nociplastic, or non-specific) that frequently overlap. The elements comprising the lumbar spine (eg, soft tissue, vertebrae, zygapophyseal and sacroiliac joints, intervertebral discs, and neurovascular structures) are prone to different stressors, and each of these, alone or in combination, can contribute to low back pain. Low back pain (LBP) is a highly prevalent and complex condition. It is associated with significant socio-economic costs. Currently, it is the leading cause of disability worldwide. Most episodes of LBP resolve within 6 weeks but 10-15% become chronic. People more often leave their job because of low back pain than diabetes, hypertension, neoplasm, asthma, heart and respiratory disease combined. More than 85% of LBP cases are categorized as nonspecific LBP (NSLBP) with no identifiable cause or pathology. Postural control, which is essential for executing functional activities, is diminished in patients with NSLBP . Chronic low back pain (CLBP) is a complex and multifactorial musculoskeletal disorder (MSKD) that has become the leading cause of disability worldwide. According to the Global Burden of Disease 2017, the years lived with disability (YLD) due to LBP increased by 52.7%, from 42.5 million in 1990 to 64.9 million in 2017. In 2019, the global LBP prevalent cases were 568.4 million, with an age standardized point-prevalence of 6972.5 per 100,000 population and 223.5 million incidence cases with an age-standardized annual incidence of 2748.9, globally. Low back pain (LBP) is the leading cause of years lived in disability in high-income and middle-income countries. Moreover, a similar increase has also been seen in low-income countries. Musculoskeletal disorders contribute about 3.4% and 1.7% of the total global burden of disease in highincome-countries and low-and-middle-income-countries, respectively.

The study aims to investigate the combined effects of sound sine wave therapy and standard physiotherapy on mechanical low back pain. This approach is rooted in the idea of enhancing conventional physiotherapy outcomes by exploring the potential benefits of sound therapy, which may include pain relief, improved mobility, restored function, and corrected pelvic alignment. By integrating these modalities, the study seeks to contribute empirical evidence to support their complementary roles in managing chronic low back pain and optimizing musculoskeletal rehabilitation strategies

Eligibility criteria: Inclusion Criteria:

* Both gender Aged 18-45 years
* Minimum 03 months chronicity of lower back pain
* Clinically diagnosed with the help of tests
* SLR test to rule out nerve root compression or disc herniation
* FABER test to rule out SI joint dysfunction
* Scobber Test to assess lumbar flexibility and mobility
* Lumber quadrant test to identify pain from facet joints
* Lumber extension test
* Pain localized to the lumbar region, potentially radiating to the buttocks or thighs but not below the knee

Exclusion Criteria:

* Chronic systemic soft tissue and bony diseases
* History of spinal trauma or fractures
* Severe spinal stenosis or spondylolisthesis
* Pain radiating to one or both legs, consistent with lumbar radiculopathy
* Participants with a known history of cervical myelopathy, characterized by symptoms of spinal cord compression in the cervical spine (e.g., neck pain with neurological deficits such as weakness, numbness, or abnormal reflexes)

Primary outcomes:
measure: NPRS
timeFrame: Baseline, 4th Week
measure: Oswetry Disability Index
timeFrame: Baseline, 4th Week
measure: Lubmbar Range of Motion
timeFrame: Baseline, 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil ur Rehman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.
citation: Hawamdeh M, Altaim TA, Shallan A, Gaowgzeh RA, Obaidat SM, Alfawaz S, Al-Nassan SM, Neamatallah Z, Eilayyan O, Alabasi UM, Albadi M. Low Back Pain Prevalence among Distance Learning Students. Int J Environ Res Public Health. 2022 Dec 26;20(1):342. doi: 10.3390/ijerph20010342.