NCT06751719

Brief Summary

Numerous studies have emphasized the debilitating effects of chronic low back pain (CLBP), which persists for over 12 weeks and impacts approximately 20% of the global population. The etiology of CLBP encompasses various factors, such as sedentary lifestyles, diminished muscle strength, poor neuromuscular control of deep trunk muscles, and compromised proprioception, all contributing to lumbar spine strain. These factors result in limitations in essential daily activities, significantly diminishing the overall quality of life. Continued exploration in this field is essential to furthering our understanding of managing chronic low back pain. Investigating alternative treatment approaches, such as proprioceptive, calisthenic, and kinesthetic exercises, contributes to expanding the range of solutions available for addressing this issue. Embracing a diverse array of interventions not only proves beneficial but also holds promise in providing long-term advantages for enhancing patients' overall well-being. Therefore, this study aims to comprehensively investigate the combined effects of proprioceptive, kinesthetic, and calisthenic exercises, alongside core stabilization exercises, in alleviating chronic low back pain and their potential to enhance range of motion and diminish functional disability in individuals with CLBP in Lahore, Pakistan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

December 20, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

Chronic Low Back PainCalisthenic exercisesProprioceptive exercisesKinesthetic exercisesDisability

Outcome Measures

Primary Outcomes (3)

  • numeric pain rating scale (NPRS)

    A numeric pain rating scale (NPRS) would be used to assess the patient's pain measure for chronic low back pain before and after exercises. This 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS has a validity of 0.86 to 0.95 and a reliability of 0.96.

    baseline, after 4 weeks

  • inclinometer

    An inclinometer would be used to measure the range of motion for the lumbar spine. The inclinometer for lumbar ROM has a reliability of 0.97.

    baseline, after 4 weeks

  • Modified ODI for disability (Urdu version)

    Modified ODI for disability (Urdu version) would be used to assess the patient's functional disability for chronic low back pain at 0 weeks and then at 4 weeks. The modified ODI has a reliability of 0.90. For each question, 0 points is the minimum, and 5 points is the maximum. Add up the total score for 10 questions.

    baseline, after 4 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

This control group will only participate in core stabilization exercises and heat therapy. The exercise session would be held 3 times a week.

Other: core stabilization exercisesOther: heat therapy

Group B

EXPERIMENTAL

This intervention group will consist of participants who will engage in proprioceptive, calisthenic, and kinesthetic exercises along with core stabilization exercises and heat therapy. The exercise session would be held 3 times a week.

Other: core stabilization exercisesOther: heat therapyOther: proprioceptive exercisesOther: calisthenic exercisesOther: kinesthetic exercises

Interventions

The core exercises would be held for 7 to 8 seconds, repeated 10 times, and rest for 3 seconds between repetitions and 1 minute rest between each exercise. These exercises will include: 1. Abdominal hollowing 2. Supine extension bridge 3. Partial Curls

Group AGroup B

The heat therapy would be applied to the lumbar region for 10 minutes.

Group AGroup B

The proprioceptive exercises will include rest for 3 seconds between repetitions and 1-minute rest between each exercise. These exercises will include: 1. One leg balance - 10 seconds hold time with 3 repetitions 2. Forward leg swings - 15 swings 3. Sideways leg swings - 15 swings

Group B

The calisthenic exercises will include: 1. Abductor's leg raise for 10 repetitions 2. Prone leg extension for 10 repetitions 3. Alternate toe touch for 10 repetitions

Group B

The kinesthetic exercises will have 1 minute rest in between exercises. These exercises will include: 1. Toe walking for 20 meters distance 2. Heel walking for 20 meters distance

Group B

Eligibility Criteria

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

You may qualify if:

  • Minimum 3 months or above LBP
  • Moderate pain (NPRS: 3-7)
  • Disability score of 19% or greater as evident from the modified Oswestry Disability Questionnaire (MODQ)

You may not qualify if:

  • History of inflammatory joint diseases e.g. rheumatoid arthritis, gouty arthritis, psoriatic arthritis, and ankylosing spondylitis
  • History of neurological deficit e.g. paresthesia, sensory loss, radiculopathy, myelopathy
  • History of surgery related to spine, lower extremities, metal implants on lower extremities
  • History of any mental illness
  • Subjects on medication e.g. antidepressants, corticosteroids, and anti-inflammatory medications
  • Other conditions include peripheral vascular diseases, recent fractures including lower limb or spine, osteoporosis, spine or other joint deformities, brain injuries, neuromuscular disorders, and respiratory diseases
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab Training and Research Center

Lahore, Punjab Province, 54760, Pakistan

Location

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Syed Shakil ur Rehman, PhD

    Riphah International University, Lahore

    STUDY DIRECTOR
  • Hatoma Fatima Malik, DPT

    Riphah International University, Lahore

    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

December 20, 2024

First Posted

December 30, 2024

Study Start

July 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations