- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06751719
Proprioceptive, Calisthenic, and Kinesthetic Exercises for Chronic Low Back Pain
Combined Effects of Proprioceptive, Calisthenic, and Kinesthetic Exercises on Pain, Range of Motion, and Functional Disability in Chronic Low Back Pain
Study Overview
Status
Conditions
Detailed Description
Chronic low back pain (CLBP) is a debilitating musculoskeletal condition primarily involving the lumbar spine, sacrum, and the surrounding soft tissue structures often resulting in the potential for pain radiating to the lower extremities (1) (2). It is characterized by prolonged pain lasting more than 12 weeks, impacting around 20% of the worldwide population (3, 4) (5). CLBP significantly impacts the quality of life affecting activities fundamental to daily living (6). Low back pain (LBP) seems to influence approximately 60% to 80% of adults in their lifespan, and almost 10% of these individuals eventually progress towards CLBP (7). The precise underlying cause of CLBP remains unknown in nearly 85% of cases. However, sedentary living habits, reduced muscle strength, poor neuromuscular control of deep trunk muscles, and proprioception are considered some of the risk factors for CLBP, contributing to strain of the lumbar spine, and leading to functional limitations. (7) (8) (9).
The patient's motivation and active participation are of utmost importance for the exercise rehabilitation program, decreasing pain and improving functional activities (2) (10). Commonly adopted exercises like extension and flexion-focused routines as well as other conservative management including spinal manipulative therapy, pain neuroscience education (PNE) and acupuncture alleviate pain and disability related to LBP (10) (4). However, the outcomes are limited and may not target the central issue of impaired lumbar joint sense, a significant factor in LBP (10) (4).
Core stabilizing exercises are a standard treatment method for CLBP (10) (8). The exercises involve combined activation and conditioning of the pelvic floor and deep core muscles, attaching to the thoracolumbar fascia (8) (10) (11). This connection results in reinforcing the lumbar spine, increasing stability and neuromuscular control through elevated abdominal pressure, and reducing stress on the lumbar vertebrae (10) (8) (11). These core stabilizing exercises also help in decreasing pain and stability, further optimizing proprioception, postural alignment, and stability in patients with LBP (9) (12). The outcome of one of the studies conducted by O'Sullivan on patients with CLBP showed that the pain intensity decreased and functional disability improved in patients in receipt of Transverse Abdominis and Multifidus muscle training for 10 weeks (3).
Proprioception refers to the body's remarkable ability to perceive and sense joint and body movements, commonly known as kinesthetic, while also perceiving the position of the body or its segments within space (13) (14). This ability contributes significantly to muscle awareness and posture, as it involves accumulating information from the surrounding environment and relaying it to the central nervous system (15) (14) (16). Reduction in proprioception can cause neuromuscular dysfunction, leading to tense, imbalanced muscular activation and compromised postural alignment (17). Consequently, prioritizing the maintenance of proprioception and improving neuromuscular function becomes crucial for engaging in daily activities without experiencing LBP (16) (14). Exercises targeting proprioception would comprise balance training, incorporating other components of balance such as the vestibular system, base of support, and center of gravity, which stimulates sensory receptors, increasing the perception of joint position and movement (16) (14). Kinesthetic exercises are essential in motor control and prediction of proprioceptive responses (18) (19). Calisthenic exercises are a series of repetitive movements that create numerous muscle contractions that can be isotonic or isometric. These type of exercises utilizes the body's weight to enhance muscular strength, endurance, flexibility, proprioception, balance, and coordination, deemed superior when compared to other exercise programs.
Chronic low back pain stands as a prevalent musculoskeletal condition worldwide, leading to significant functional limitations and disability. This presents a complex issue within both healthcare infrastructures and socioeconomic frameworks, necessitating focused attention and effective solutions. While alternative treatment methods exist, ongoing research in this area would facilitate the development of additional solutions for managing low back pain, enhancing the patient's plan of care. A diverse range of interventions prove beneficial, ultimately offering long-term advantages for patients' well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54760
- Riphah Rehab Training and Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum 3 months or above LBP
- Moderate pain (NPRS: 3-7)
- Disability score of 19% or greater as evident from the modified Oswestry Disability Questionnaire (MODQ)
Exclusion Criteria:
- History of inflammatory joint diseases e.g. rheumatoid arthritis, gouty arthritis, psoriatic arthritis, and ankylosing spondylitis
- History of neurological deficit e.g. paresthesia, sensory loss, radiculopathy, myelopathy
- History of surgery related to spine, lower extremities, metal implants on lower extremities
- History of any mental illness
- Subjects on medication e.g. antidepressants, corticosteroids, and anti-inflammatory medications
- Other conditions include peripheral vascular diseases, recent fractures including lower limb or spine, osteoporosis, spine or other joint deformities, brain injuries, neuromuscular disorders, and respiratory diseases
- Pregnancy
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: Group A
This control group will only participate in core stabilization exercises and heat therapy.
The exercise session would be held 3 times a week.
|
The core exercises would be held for 7 to 8 seconds, repeated 10 times, and rest for 3 seconds between repetitions and 1 minute rest between each exercise. These exercises will include:
The heat therapy would be applied to the lumbar region for 10 minutes.
|
|
Experimental: Group B
This intervention group will consist of participants who will engage in proprioceptive, calisthenic, and kinesthetic exercises along with core stabilization exercises and heat therapy.
The exercise session would be held 3 times a week.
|
The core exercises would be held for 7 to 8 seconds, repeated 10 times, and rest for 3 seconds between repetitions and 1 minute rest between each exercise. These exercises will include:
The heat therapy would be applied to the lumbar region for 10 minutes.
The proprioceptive exercises will include rest for 3 seconds between repetitions and 1-minute rest between each exercise. These exercises will include:
The calisthenic exercises will include:
The kinesthetic exercises will have 1 minute rest in between exercises. These exercises will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numeric pain rating scale (NPRS)
Time Frame: baseline, after 4 weeks
|
A numeric pain rating scale (NPRS) would be used to assess the patient's pain measure for chronic low back pain before and after exercises.
This 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
The NPRS has a validity of 0.86 to 0.95 and a reliability of 0.96.
|
baseline, after 4 weeks
|
|
inclinometer
Time Frame: baseline, after 4 weeks
|
An inclinometer would be used to measure the range of motion for the lumbar spine.
The inclinometer for lumbar ROM has a reliability of 0.97.
|
baseline, after 4 weeks
|
|
Modified ODI for disability (Urdu version)
Time Frame: baseline, after 4 weeks
|
Modified ODI for disability (Urdu version) would be used to assess the patient's functional disability for chronic low back pain at 0 weeks and then at 4 weeks.
The modified ODI has a reliability of 0.90.
For each question, 0 points is the minimum, and 5 points is the maximum.
Add up the total score for 10 questions.
|
baseline, after 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Syed Shakil ur Rehman, PhD, Riphah International University, Lahore
- Principal Investigator: Hatoma Fatima Malik, DPT, Riphah International University, Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Hatoma Fatima Malik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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