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

March 4, 2024 updated by: Riphah International University

Effects of Core Muscle Activation Exercise Training Program on Pain, Range of Motion, and Function in Patients With Chronic Low Back Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Orthopedics Medical Complex Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Spinal mobilization and core stabilization exercises group:
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
Core muscles activation exercises will be performed on patients to target the abdominals.
Other: Spinal mobilization techniques
lumbar spine joint mobilization techniques will be performed to patient in prone lying.
Active Comparator: Spinal mobilization techniques group
will have lumber spine joint mobilization along with TENS and Ultrasound duration of 12 weeks with 3 sessions per week.
Other: Spinal mobilization techniques
lumbar spine joint mobilization techniques will be performed to patient in prone lying.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bubble base inclinometer for Range of Motion
Time Frame: up to 12 weeks
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
Time Frame: up to 12 weeks
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
Time Frame: up to 12 weeks
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
Time Frame: up to 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sana Gohar, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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