NCT05854758

Brief Summary

The goal of this clinical trial is to determine the effects of core strengthening on mechanical back pain in overweight adults. The main question is aims to answer: Is there an effect of core strengthening on mechanical back pain in overweight adults? The participants will be divided into two groups; group A and group B Group A will perform core strengthening after baseline treatment of therapeutic hot pack and Trans continuous mode for 10 minutes. Group B will perform conventional exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

May 3, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

low back painoverweightexercisecore strengtheningnumerical pain rating scale

Outcome Measures

Primary Outcomes (4)

  • Numerical Pain Rating Scale

    The 11-point Numerical Pain Rating Scale consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity

    6 weeks

  • Oswestry Low Back Pain Disability Questionnaire

    The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain. Psychometric properties of the ODI will determine the questionnaire's suitability as a useful clinical tool. The ODI is a valid, reliable, and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients' complaints, and monitors effects of therapy

    6 weeks

  • Body Mass Index

    Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.

    6 weeks

  • Total Body Fat

    The Jackson-Pollack method for evaluating body fat percentage requires three skin fold measurements. For men, measurement sites are the chest, abdomen and thigh; for women, they consist of the thigh, triceps and suprailiac crest, or just above the top of the hip bone. Because measurements are taken in very specific spots, precise locations are typically measured and marked with a washable marker before the test is conducted. For consistency and accuracy, all skin fold measurements are taken at least twice on the right side of a standing, relaxed body and should never be taken after exercise, when a person's fluid levels can interfere with accuracy. Measurements are taken on the right side of body. Caliber needs to be perpendicular to the site analyzed.

    6 weeks

Study Arms (2)

Core strengthening with conventional treatment

EXPERIMENTAL

This group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation continuous mode for 10 minutes.

Other: Core strengthening with conventional treatment

Conventional treatment

ACTIVE COMPARATOR

This group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval

Other: Conventional treatment

Interventions

A detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes. This group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes.

Core strengthening with conventional treatment

A detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes. This group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval

Conventional treatment

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males \& Female
  • Age: 25-45
  • Chronic low back pain for more than 3 months .
  • BMI of 25 or greater
  • Body fat percentage \> 25%
  • Numerical Pain Rating Scale ratings less than 7

You may not qualify if:

  • Participant failing to fall in this category would be excluded of the study.
  • Patients with non-mechanical low back pain
  • Patients with acute low back pain.
  • Post laminectomy/discectomy
  • Spondylolisthesis
  • Osteoporosis/Fractures
  • Cauda equine syndrome
  • Recent history of spinal trauma or surgery
  • Lumbar myelopathy
  • Patients with known metabolic diseases
  • Patients with any neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elite Physical Therapy Centre

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back PainOverweightMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightBehavior

Study Officials

  • Jawad Naweed, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 11, 2023

Study Start

November 1, 2022

Primary Completion

June 10, 2023

Study Completion

July 8, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations