Clinical trial NCT07026097: Online Versus Physically Supervised Pilates Exercise Program in Non-specific Low Back Pain
Official title: Effects of Online Versus Physically Supervised Pilates Exercise Program With Common Standard Physical Therapy Treatment on Pain, Mobility and Function in Patients With Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Pilates Training
Pilates Based Exercises
Range of Motion
Disability
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 will be Randomized Controlled Trial and will be conducted in Riphah Rehabilitation Research Center. The study duration will be 9 months. Non- probability convenient sampling technique will be used to collect the data. Patients with chronic non-specific low back pain will be included in this study after meeting the inclusion criteria. The sample size of this study is 40 participants 20 in each group. Both groups will be an experimental group and will receive Pilates exercise protocol and common standard physical therapy treatment, 02 times a week for 04 weeks. Group A will receive supervised online Pilates exercise plan with common standard physical therapy and Group B will receive clinical supervised Pilates with common standard physical therapy treatment. The common standard physical therapy plan will be a hot pack for lumbar region for 10 mins, hamstring stretch, participants should maintain this stretch for 30 secs with 10 repetitions and strengthening of abdominal muscles in crook lying position with 10 repetitions with hold of 30 sec. The Pilates exercise protocol will include rollup, one leg circle exercise, crook leg lying, prone single leg kick, side-lying clamshell, supine stretch exercise, bug roll, prone attitude rotation, side kick and saw exercise. The Pilates protocol will be of 30 mins with 06-10 repetitions for each exercise withhold time for 30 sec. The outcome measure will be Numeric Pain Rating Scale (NPRS) for pain, Oswestry Low Back Disability Questionnaire (ODI) for disability and inclinometer for range of motion.

Detailed description: Low back pain (LBP) is characterised by pain, muscle tension or stiffness located below the 12th rib and above the gluteal folds . In many patients, the specific nociceptive source of LBP cannot be identified and those affected are often classified as having nonspecific low back pain. Nonspecific LBP represents 90% to 95% of cases . Chronic non-specific LBP (CNLBP) is distinguished by persistent pain for more than 12 weeks, without a clear cause. This condition is considered one of the most common causes of disability. It is estimated that 80% of adults have at least one episode of LBP during their lifetime and aproximately 85% of cases falling under the umbrella of non-specific LBP, often labelled as idiopathic low back dysfunction due to the absence of identifiable anatomical abnormalities .

Low back pain (LBP) is a great public health issue and the second most common cause of seeking advice from a physician. It is the leading source of human suffering and disability worldwide . Approximately 15% to 20% of adults suffer from back pain each year. The issue is common in both developing and developed countries of the world . As compared to developed countries low back pain is more prevalent in developing countries. It is considered the second most common disease in adults under the age of 45 years .

The prevalence of low back pain among older population is 40.6% in Pakistan. In Pakistan, the prevalence is notably high, ranging from 29.20% to 70%. Individuals experiencing low back dysfunction grapple with various musculoskeletal symptoms, including pain, restricted range of motion (ROM) and a decline in functional indices. Now a days low back pain is also very common is younger population a study shows that 25.1% males and 36.8% females of age ranging 18-25 also experience low back pain in Pakistan. 84% population of USA have low back pain. it is estimated that 70-85% of the working population has suffered from a LBP episode, with many reports of long periods of absence from their jobs, restricting their physical activity and affecting their output and the quality of life.

With the rise of digital platforms and global pandemic, there has been a significant shift towards online fitness program. Investigating the effectiveness of online Pilates can provide information whether these programs will work better compared to traditional, in person programs. Online Pilates offers greater accessibility for individuals who, may not have an easy access to clinics due to geographic, financial or time constraints. This research will help determine if online Pilates can deliver similar benefits to in-person therapy, making treatment more accessible to patients. This study will help practitioners in making informed choices whether online Pilates or clinical Pilates which is better for the patients. Another impact is that by giving treatment online cost of the treatment will also reduce which is beneficial for the patients. So, the purpose of this study is to compare the effects of online versus physically supervised Pilates exercise program with common standard Physical Therapy Treatment on pain, mobility and function in patients with non-specific low back pain.

Eligibility criteria: Inclusion Criteria:

* Patients with LBP
* Minimum chronicity of LBP 03
* Both Gender
* Age ranges from 18-40
* Numeric pain rating scale (NPRS) score 3 to 8 for pain intensity
* Patient who can maintain their standing posture independently for ≥30 minutes, have enough physical autonomy to participate in the physical activities required by the study
* Oswestry Disability Index score 20-34

Exclusion Criteria:

* History of trauma or fracture of the supine
* Chronic systemic soft tissue or bony disease
* Post Operative
* Pregnancy
* Diagnosis of osteoarthritis and herniated disc
* Any medical red flags
* Neurological and visual impairments
* Presence of root symptoms (e-g sciatica and cauda equina syndrome)

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline, 4th week
measure: Oswetry Disability Index
timeFrame: Baseline, 4th week
measure: Lumbar 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: Siddiqui AS, Javed S, Abbasi S, Baig T, Afshan G. Association Between Low Back Pain and Body Mass Index in Pakistani Population: Analysis of the Software Bank Data. Cureus. 2022 Mar 30;14(3):e23645. doi: 10.7759/cureus.23645. eCollection 2022 Mar.
citation: Nieminen LK, Pyysalo LM, Kankaanpaa MJ. Prognostic factors for pain chronicity in low back pain: a systematic review. Pain Rep. 2021 Apr 1;6(1):e919. doi: 10.1097/PR9.0000000000000919. eCollection 2021.