Sound Sine Wave And Standard Physiotherapy In Mechanical Low Back Pain

NCT07026058 | Recruiting DMC

• 1 other identifier: Aleena- REC/RCR&AHS 24/0135
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pian; Physical Therapy; Disability; Pelvic Alignment; Range of Motion; Pain

Outcome Measures

Primary Outcomes (3)

• NPRS

  Baseline, 4th Week

• Oswetry Disability Index

  Baseline, 4th Week

• Lubmbar Range of Motion

  Baseline, 4th Week

Study Arms (2)

Group A

EXPERIMENTAL

Other: Sound Wave Treatment

Group B

ACTIVE COMPARATOR

Other: Standard physiotherapy

Interventions

Sound Wave Treatment OTHER

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.

Group A

Standard physiotherapy OTHER

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

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 34115979 BACKGROUND

• 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.

  PMID: 36612660 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Syed Shakil ur Rehman, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Shakil ur Rehman, PhD

CONTACT

+92 320 786661; shakil.urrehman@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start: May 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 28, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)