- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07845760
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability by Numerical Pain Rating Scale and Modified Oswestry Disability Index Respectively. (A RCT)
Effect of Lumbar Stabilization Exercises With and Without YTWL Exercise on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial.
Chronic low back pain is a common problem that can make daily activities difficult. Exercises that strengthen and stabilize the lower back are commonly used to reduce pain and improve movement.
This study will examine whether adding shoulder-blade (scapular) strengthening exercises called YTWL exercises to regular lower-back exercises can provide better results than lower-back exercises alone.
A total of 70 people with chronic non-specific low back pain will participate. They will be divided into two groups:
Group 1: Lower-back stabilization exercises + heating pad Group 2: Lower-back stabilization exercises + YTWL shoulder-blade exercises + heating pad
Pain and difficulty in performing daily activities will be measured before treatment and after 4 weeks.
The purpose of this study is to find out whether improving the strength and stability of the shoulder-blade muscles along with the lower-back muscles can reduce pain and disability more effectively.
In simple words: We want to know whether exercising both the upper back/shoulder-blade muscles and lower-back muscles works better for chronic low back pain than exercising the lower back alone.
Study Overview
Status
Detailed Description
Background:
Chronic low back pain is a common health problem that can affect a person's ability to work, exercise, sleep, and perform everyday activities. In many people, the exact cause of the pain cannot be identified. This is known as non-specific chronic low back pain (NSCLBP). Chronic low back pain is generally considered pain in the lower back that continues for more than three months without a specific disease or injury being identified as the cause.
People with chronic low back pain may experience pain, stiffness, difficulty moving, reduced muscle strength and endurance, and difficulty performing activities such as walking, sitting, standing, bending, or lifting. Factors such as prolonged sitting, poor posture, reduced muscle endurance, and poor control of body movements may contribute to the problem.
Purpose of the Study:
Exercise is an important part of physiotherapy treatment for chronic low back pain. Lumbar stabilization exercises (LSE) are commonly used to improve the strength and control of the muscles that support the spine. These exercises can help reduce pain and improve a person's ability to perform daily activities.
However, the muscles of the lower back do not work alone. The muscles around the abdomen, pelvis, upper back, and shoulder blades work together to control body movement. This connection is known as the kinetic chain. Weakness or poor endurance of the muscles around the shoulder blades may affect the way the trunk and pelvis move and may influence lower-back function.
This study will therefore investigate whether adding scapular stabilization exercises (SSE), specifically YTWL exercises, to conventional lumbar stabilization exercises can provide additional benefits for people with chronic non-specific low back pain.
What are YTWL exercises? YTWL exercises are simple exercises designed to strengthen and improve the control and endurance of muscles around the shoulder blades and upper back. The exercises involve moving the arms into positions that resemble the letters Y, T, W, and L. These movements target muscles such as the trapezius, rhomboids, and serratus anterior, which help keep the shoulder blades stable.
What will happen in the study? A total of 70 people with chronic non-specific low back pain will be included in the study. Participants will be recruited from the Physical Therapy Outpatient Department at Dow University Hospital, Ojha Campus.
Participants will be divided into two groups:
Group 1 (Control Group): Participants will receive conventional lumbar stabilization exercises along with a heating pad.
Group 2 (Experimental Group): Participants will receive conventional lumbar stabilization exercises, YTWL scapular stabilization exercises, and a heating pad.
Both groups will receive treatment for 4 weeks.
Before starting the treatment and after completing the 4-week treatment period, participants' outcomes will be assessed. The main areas being assessed are pain and disability.
Assessment of Pain:
Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS). Participants will rate their pain on a scale from 0 to 10, where 0 means no pain and 10 represents the worst possible pain.
Assessment of Disability:
The effect of back pain on daily activities will be assessed using the Modified Oswestry Disability Index (MODI). This questionnaire evaluates how back pain affects activities such as walking, sitting, standing, lifting, personal care, and other daily activities.
The assessments will be performed before the treatment begins and after 4 weeks of treatment. The results from the two groups will then be compared using statistical analysis through SPSS software.
Why is this study important? The study may help determine whether adding exercises for the shoulder-blade muscles to conventional lower-back exercises provides additional benefits for people with chronic low back pain.
If the combined exercise program produces better results, it may provide physiotherapists with an additional exercise approach for managing patients with chronic non-specific low back pain. It may also help patients improve their physical function and reduce the effect of back pain on their daily lives.
For patients and families:
The study does not involve surgery or invasive procedures. It focuses on therapeutic exercises and a heating pad. Participants will be monitored during the treatment period, and their pain and ability to perform daily activities will be assessed before and after the intervention.
Overall aim:
The overall aim of this study is to determine whether adding YTWL scapular stabilization exercises to conventional lumbar stabilization exercises is more effective in reducing pain and disability than lumbar stabilization exercises alone in people with chronic non-specific low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sadia Akhter, Doctor of Physical Therapy
- Phone Number: +92-3312753480
- Email: sadiaakhter333@gmail.com
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 75290
- Dow University of Health Sciences
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Contact:
- Sadia Akhter, DPT
- Phone Number: 03312753480
- Email: sadiaakhter333@gmail.com
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Principal Investigator:
- Sadia Akhter, Doctor of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Both gender (Male and female) Age ranges between 18-50 years. Patient having LBP for more or equal to 3 months due to mechanical cause referred from physician.
Had no prior physical therapy sessions for CLBP in previous month. NPRS score = 3-6/10 Modified Oswestry Disability Index (ODI) score ranging from 11 to 30 out of 50 (21-60%)
Exclusion Criteria:
Low back pain due to any systemic cause. History of known scapular pathology. (Scapular fracture, Sprengel deformity, Os acromiale, injury to neurovascular structures of scapular muscles) History of specific causes of Low Back Pain (Spinal stenosis, Spondylosis, Spondylolisthesis, Disc herniation, Cauda equine syndrome) Any history of infective or inflammatory spinal pathology, spinal surgery and spinal fracture.
History of any psychological disorders Pregnancy Malignancy Obvious neurological symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group (A)
Lumbar Stabilization Exercises (LSE) + Heating Pad |
Participants in the control group will receive conventional lumbar stabilization exercises (LSE) along with a heating pad for 4 weeks, with the aim of reducing low back pain and related disability. |
|
Experimental: Experimental Group (B)
Lumbar Stabilization Exercises (LSE) + YTWL Scapular Stabilization Exercises + Heating Pad |
Participants in the experimental group will receive lumbar stabilization exercises (LSE) combined with YTWL scapular stabilization exercises and a heating pad for 4 weeks, with the aim of reducing low back pain and related disability. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Oswestry Disability Index (MODI)
Time Frame: Before and after 4 weeks of intervention.
|
The Modified Oswestry Disability Index (MODI) is a questionnaire used to measure the level of disability caused by low back pain and how it affects a person's daily activities. It assesses areas such as pain, personal care, lifting, walking, sitting, standing, sleeping, social life, and traveling. Participants complete the questionnaire before the intervention and after 4 weeks, and the score is used to determine changes in disability following treatment. |
Before and after 4 weeks of intervention.
|
|
Numerical Pain Rating Scale (NPRS)
Time Frame: Participants will rate the intensity of their low back pain at the time of assessment (current pain), before the intervention and after 4 weeks of treatment.
|
The Numerical Pain Rating Scale (NPRS) is a simple 0-10 scale used to measure the intensity of a patient's pain. 0 represents "no pain," while 10 represents "the worst possible pain." |
Participants will rate the intensity of their low back pain at the time of assessment (current pain), before the intervention and after 4 weeks of treatment.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sadia Akhter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
No individual participant data will be shared. Only aggregate, de-identified study results may be reported or published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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