Clinical trial NCT05905562: Core Muscle Activation Exercise Training Program Effects in Patients With Chronic Low Back Pain
Official title: Effects of Core Muscle Activation Exercise Training Program on Pain, Range of Motion, and Function in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a Randomized clinical trial to check the effects of a core muscle activation exercise training program on pain, range of motion, and function in patients with chronic low back pain so that we can devise a treatment protocol for patients with chronic low back pain. The study duration was 10 months, convenient sampling technique was used subject following eligibility criteria from the Orthopaedic medical center, Lahore. were randomly allocated in two groups via lottery method, a baseline assessment was done, and Group A received Mobilization and Electrotherapy Modalities including Ultrasound, TENS, and Core muscles activation exercises. Group B received Mobilization and Electrotherapy Modalities including Ultrasound and TENS for a total training program duration of 12 weeks with 3 sessions per week. Outcome measures were NPRS for assessment of pain, Modified Oswestry Disability index for functional disability, PBU for assessment and training of core stability, and baseline bubble inclinometer and were assessed and documented at 0 week, 4 weeks, 8 weeks, and 12 weeks of the treatment session

Detailed description: Low back pain is one of the most common musculoskeletal disorders in both males and females, with a prevalence rate of 80% of the world population. However, in some cases, acute low back pain persists for more than 3 months and becomes chronic low back pain. During low back pain, significant complaints of patients other than pain are decreased mobility and functional limitations in their workplace and at home In recent years, multiple studies have explored the evidence for treating chronic low back pain; options include soft tissue mobilization, spinal manipulation therapy, spinal joint mobilization therapy, behavioral therapy, exercise therapy, transcutaneous electrical nerve stimulation, interferential currents, low-level laser therapy, and yoga. Other treatments include massage, acupuncture, and superficial heat therapy thermal heat wraps, hot water bottles, heated packs filled with grain, hot towels, and electric heating pads). Manual modalities such as physiotherapy, massage, chiropractic, occupational, and osteopathic therapies, including spinal manipulation and mobilization, are often used together and alone to treat chronic non-specific low back pain Exercises are a way to induce strength, endurance, functional mobility, and neuromuscular control in back muscles. A variety of Exercises like Motor control stabilization exercises, back stabilization exercises, core muscle activation exercises, and endurance exercises are used to reduce the effect of low back pain. These particular exercises are for lumber and core Stabilization and strengthening but there is very limited research on the superiority of each exercise over the other.

Earlier work suggested that there is little or no evidence that spinal manipulative therapy was superior to other standard treatments for chronic low back pain. however, recent systematic reviews suggest that spinal manipulation and mobilization are "viable" options for pain treatment

Eligibility criteria: Inclusion Criteria:

* • Both Gender

  * Age range from 20-50 years.
  * Chronicity of low back pain for at least 3 months.

Exclusion Criteria:

* Patients with any signs of spinal cord involvement
* Pregnant female patients
* History of spinal trauma or spinal or abdominal surgery
* History of systemic disease (e.g., systemic scleroderma or muscular dystrophy), spinal deformity (e.g., scoliosis and kyphosis), or abdominal wall hernia
* History of participation in core stability exercise or any physical therapy treatment in the past 6 months
* Any bony or soft tissue systemic disease

Primary outcomes:
measure: Bubble base inclinometer for Range of Motion
timeFrame: up to 12 weeks
measure: Pressure biofeedback unit for Muscle strength
timeFrame: up to 12 weeks
measure: Numeric Pain Rating Scale
timeFrame: up to 12 weeks
measure: Modified Oswestry Disability Index
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Orthopedics Medical Complex Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sana Gohar, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
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citation: Mueller J, Niederer D. Dose-response-relationship of stabilisation exercises in patients with chronic non-specific low back pain: a systematic review with meta-regression. Sci Rep. 2020 Oct 9;10(1):16921. doi: 10.1038/s41598-020-73954-9.
citation: Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
citation: Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
citation: Kumar T, Kumar S, Nezamuddin M, Sharma VP. Efficacy of core muscle strengthening exercise in chronic low back pain patients. J Back Musculoskelet Rehabil. 2015;28(4):699-707. doi: 10.3233/BMR-140572.
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