Low Back PainNCT07026058
Sound Sine Wave And Standard Physiotherapy In Mechanical Low Back Pain
A study testing Sound Wave Treatment and Standard physiotherapy in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Sound Wave Treatment and Standard physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 28 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah Rehabilitation Clinic
Lahore, Punjab Province, 54000
Syed Shakil ur Rehman, PhD, +92 320 7866611, shakil.urrehman@riphah.edu.pk
Aleena Jafar, MS*
About this study
Official title: Effects Of Sound Sine Wave And Standard Physiotherapy On Pain, Mobility, Function And Pelvic Alignment In Mechanical Low Back Pain
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.
Read the 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
- Conditions
- Low Back Pain
- Being tested
- Sound Wave Treatment, Standard physiotherapy
- Keywords
- Low Back Pian, Physical Therapy, Disability, Pelvic Alignment, Range of Motion, Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Wave TreatmentOther
Sound wave treatment with 6 sessions initially, 3 times a week, followed by the next 6 sessions with a frequency of 2 times a week. Patient's position was analysed through digital X-ray of cervical spine, 80 pulses are typically administered in a session. These pulses are applied generally, targeting the 1st cervical vertebra of the spine. This method aims to achieve spinal alignment through the vibrations generated by the treatment. Before and after the treatment, a patient assessment is conducted to observe visible improvements. A mixed waveform of 8Hz-202 Hz resonated throughout the spine, with intensities ranging from 0.3 to 1. In order to affect the lumbar region, where they are also applied, sound waves are employed to activate C1.
After First 3 sessions vibrations on pain focal points also given to the patient the 40 pulses are typically administrated at pain point.
Standard physiotherapyOther
Flexibility Training: Stretching exercises are crucial to improve the flexibility of the spine and surrounding muscles. This includes stretches for the hamstrings, hip flexors, and lower back Strengthening Exercises: Focus on strengthening the core muscles, including the abdominal and back muscles. Common exercises include pelvic tilts, bridging, and lumbar stabilization exercises Postural Training: Education and exercises to correct posture are vital. Proper posture reduces strain on the spine and helps prevent further injury.(31). Techniques such as ergonomic adjustments at work and home, along with exercises like seated squats and calf stretches Manual Therapy: Techniques such as myofascial release (32) and spinal mobilization. Spinal mobilization as one of the most preferable approaches for the management of LBP
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Sound Wave Treatment |
| Group B | Active comparator | Not described Receives: Other: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Measured: Baseline, 4th Week
Oswetry Disability Index
Measured: Baseline, 4th Week
Lubmbar Range of Motion
Measured: Baseline, 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion28 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026058
- Sponsor's protocol ID
- Aleena- REC/RCR&AHS 24/0135
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34115979Hawamdeh 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.
PubMed 36612660
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Sound Sine Wave And Standard Physiotherapy On Pain, Mobility, Function And Pelvic Alignment In Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07026058
- Acronym / sponsor ID
- Aleena- REC/RCR&AHS 24/0135
- Conditions
- Low Back Pain
- Keywords
- Low Back Pian, Physical Therapy, Disability, Pelvic Alignment, Range of Motion, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 28 Sep 2025 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Sound Wave Treatment |
| Group B | Active comparator | Other: Standard physiotherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound Wave TreatmentSound wave treatment with 6 sessions initially, 3 times a week, followed by the next 6 sessions with a frequency of 2 times a week. Patient's position was analysed through digital X-ray of cervical spine, 80 pulses are typically administered in a session. These pulses are applied generally, targeting the 1st cervical vertebra of the spine. This method aims to achieve spinal alignment through the vibrations generated by the treatment. Before and after the treatment, a patient assessment is conducted to observe visible improvements. A mixed waveform of 8Hz-202 Hz resonated throughout the spine, with intensities ranging from 0.3 to 1. In order to affect the lumbar region, where they are also applied, sound waves are employed to activate C1. After First 3 sessions vibrations on pain focal points also given to the patient the 40 pulses are typically administrated at pain point. | Other | Group A |
| Standard physiotherapyFlexibility Training: Stretching exercises are crucial to improve the flexibility of the spine and surrounding muscles. This includes stretches for the hamstrings, hip flexors, and lower back Strengthening Exercises: Focus on strengthening the core muscles, including the abdominal and back muscles. Common exercises include pelvic tilts, bridging, and lumbar stabilization exercises Postural Training: Education and exercises to correct posture are vital. Proper posture reduces strain on the spine and helps prevent further injury.(31). Techniques such as ergonomic adjustments at work and home, along with exercises like seated squats and calf stretches Manual Therapy: Techniques such as myofascial release (32) and spinal mobilization. Spinal mobilization as one of the most preferable approaches for the management of LBP | Other | Group B |
Primary outcome
NPRS
Time frame: Baseline, 4th Week
Oswetry Disability Index
Time frame: Baseline, 4th Week
Lubmbar Range of Motion
Time frame: Baseline, 4th Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 34115979Knezevic 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.
- Background: PubMed 36612660Hawamdeh 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syed Shakil ur Rehman, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Wave Treatment and Standard physiotherapy in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Shakil ur Rehman, PhD (+92 320 786661, shakil.urrehman@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: Baseline, 4th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07026058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.