Core Muscle Activation Exercise Training Program Effects in Patients With Chronic Low Back Pain

NCT05905562 | Completed

• 1 other identifier: REC/RCR & AHS/23/0114
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Bubble base inclinometer for Range of Motion

  It will be used to measure lumbar Range of motion. It will be placed near the joint to be measured; turn the dial until the scale reads zero; take the joint through its range and range of motion will be recorded (in degrees) directly from the dial.

  up to 12 weeks

• Pressure biofeedback unit for Muscle strength

  Pressure Biofeedback Unit will be use to assess core stability muscle strength contraction. pressure biofeedback unit will be placed under the lumbar spine at the height of L3 and inflate the cuff to 40mmHg.The patient is then instructed to perform core contraction and increase the pressure in steps of 2-4mmHg. So from 40 to 42or44mmHg and so on. The contraction should be held whilst being able to keep breathing calmly. Ideally, the patient is able to hold this contraction for 15 seconds. Time will be noted.

  up to 12 weeks

• Numeric Pain Rating Scale

  The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes

  up to 12 weeks

• Modified Oswestry Disability Index

  The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.

  up to 12 weeks

Study Arms (2)

Spinal mobilization and core stabilization exercises group:

EXPERIMENTAL

will have core muscle activation exercises along with lumber spine joint mobilization along with TENS and Ultrasound for 12 weeks and 3 sessions per week

Other: core stabilization exercises; Other: Spinal mobilization techniques

Spinal mobilization techniques group

ACTIVE COMPARATOR

will have lumber spine joint mobilization along with TENS and Ultrasound duration of 12 weeks with 3 sessions per week.

Other: Spinal mobilization techniques

Interventions

core stabilization exercises OTHER

Core muscles activation exercises will be performed on patients to target the abdominals.

Spinal mobilization and core stabilization exercises group:

Spinal mobilization techniques OTHER

lumbar spine joint mobilization techniques will be performed to patient in prone lying.

Spinal mobilization and core stabilization exercises group:; Spinal mobilization techniques group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Orthopedics Medical Complex Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 29371112 BACKGROUND

• Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.

  PMID: 30248035 BACKGROUND

• Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.

  PMID: 31908589 BACKGROUND

• Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.

  PMID: 31631992 BACKGROUND

• 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.

  PMID: 33037280 BACKGROUND

• 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.

  PMID: 33922389 BACKGROUND

• 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.

  PMID: 34847915 BACKGROUND

• 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.

  PMID: 25467999 BACKGROUND

• Sanchez Romero EA, Fernandez Carnero J, Villafane JH, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Laguarta Val S, Pedersini P, Pecos Martin D. Prevalence of Myofascial Trigger Points in Patients with Mild to Moderate Painful Knee Osteoarthritis: A Secondary Analysis. J Clin Med. 2020 Aug 7;9(8):2561. doi: 10.3390/jcm9082561.

  PMID: 32784592 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sana Gohar, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 15, 2023
• Study Start: April 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)