search
Back to results

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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core stabilization exercises
Spinal mobilization techniques
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedics Medical Complex HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal mobilization and core stabilization exercises group:

Spinal mobilization techniques group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
June 6, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05905562
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal mobilization and core stabilization exercises group:
Arm Type
Experimental
Arm Description
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
Arm Title
Spinal mobilization techniques group
Arm Type
Active Comparator
Arm Description
will have lumber spine joint mobilization along with TENS and Ultrasound duration of 12 weeks with 3 sessions per week.
Intervention Type
Other
Intervention Name(s)
core stabilization exercises
Intervention Description
Core muscles activation exercises will be performed on patients to target the abdominals.
Intervention Type
Other
Intervention Name(s)
Spinal mobilization techniques
Intervention Description
lumbar spine joint mobilization techniques will be performed to patient in prone lying.
Primary Outcome Measure Information:
Title
Bubble base inclinometer for Range of Motion
Description
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.
Time Frame
up to 12 weeks
Title
Pressure biofeedback unit for Muscle strength
Description
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.
Time Frame
up to 12 weeks
Title
Numeric Pain Rating Scale
Description
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
Time Frame
up to 12 weeks
Title
Modified Oswestry Disability Index
Description
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.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD*
Phone
051-5481826
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Gohar, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedics Medical Complex Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29371112
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.
Results Reference
background
PubMed Identifier
30248035
Citation
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.
Results Reference
background
PubMed Identifier
31908589
Citation
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.
Results Reference
background
PubMed Identifier
31631992
Citation
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.
Results Reference
background
PubMed Identifier
33037280
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.
Results Reference
background
PubMed Identifier
33922389
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.
Results Reference
background
PubMed Identifier
34847915
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.
Results Reference
background
PubMed Identifier
25467999
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.
Results Reference
background
PubMed Identifier
32784592
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs