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Low Back PainNCT05021003

Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain

A study testing pressure biofeedback and core stabilization exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mechanical low back pain is an impairment of musculoskeletal system. Lifetime prevalence of low back pain is 60-85%. Frequent micro-trauma to the structures of the spine, poor control and stabilization leads to LBP and eventually causes functional limitation. Read more about this study

Who is it for?
Ages 25 to 40 years
Conditions the study is for
Low Back Pain
What is being tested?
pressure biofeedback and core stabilization exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePakistan
Study dates
5 Aug 2021to 30 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female patients between the age group 25-40 years having mechanical low back pain persisting for at least 6 months upto1 year.
  • Patients complaining Pain when sitting or standing for a long period or Pain when driving long distance, getting in and out of the car or lifting activities.
  • Patients with minimum and moderate disability based on Modified Oswestry Disability Index (ODI).
  • Patients with greater than and equal to 7 score on NPRS.

Who cannot join

  • Structural deformity (scoliosis, lordosis).
  • Systematic inflammatory disease (vasculitis, connective tissue disease and granulomatous disease).
  • Nerve root compression (Disc bulge and Lumbar radiculopathy).
  • History of spinal surgery or fractures (laminectomy).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Mechanical low back pain is an impairment of musculoskeletal system. Lifetime prevalence of low back pain is 60-85%. Frequent micro-trauma to the structures of the spine, poor control and stabilization leads to LBP and eventually causes functional limitation. The objective of the study to find whether Core Stabilization Training with Pressure Biofeedback could reduce pain and improves functional activity in patients with mechanical low back pain. To study the effectiveness of Core Stabilization Training with Pressure Biofeedback in reducing pain and improving functional activity in subjects with mechanical low backpain between the age group of 25-40 years. To find out the effect of core stabilization training with pressure biofeedback in reducing pain and improving functional activity in subjects with mechanical low back pain between the age group of 25-40 years. The study will be conducted on 30 subjects between the age group of 25-40 years with mechanical low back pain and according to the inclusion criteria were recruited in the study. NPRS at rest and activity, Modified ODI will assess PRE and POST treatment. P value: less than 0.05 using SPSS (Statistical package for social sciences) for NPRS(pain at rest and activity) and modified ODI i.e. core stabilization training with pressure biofeedback had statistical improvement in NPRS (Pain at rest and activity) and modified ODI score. Core stabilization training with pressure biofeedback is effective inreducing pain (at rest and activity) and functional disability in subjects between the age group of 25-40 years with mechanical low back pain

Conditions
Low Back Pain
Being tested
pressure biofeedback, core stabilization exercises
Keywords
Pain, Back, Core stabilization, Pressure biofeedback
Medical subject headings
Low Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pressure biofeedbackOther

    : Core stabilization training with pressure biofeedback unit

  • core stabilization exercisesOther

    : Core stabilization training without pressure biofeedback unit

Study groups in NCT05021003
Study groupRoleWhat they receive
Group AExperimental: Core stabilization training with pressure biofeedback unit
Receives: Other: pressure biofeedback
Group BActive comparator: Core stabilization training without pressure biofeedback unit
Receives: Other: core stabilization exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NPRS

    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity [1]. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible

    Measured: 4 weeks

  2. oswestry disability index

    Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start5 Aug 2021
  3. Primary completion30 Jan 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05021003
Sponsor's protocol ID
REC/Lhr/21/0117 Hashim
Status last verified
Apr 2022
First submitted
23 Aug 2021
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burton AK, Balague F, Cardon G, Eriksen HR, Henrotin Y, Lahad A, Leclerc A, Muller G, van der Beek AJ; COST B13 Working Group on Guidelines for Prevention in Low Back Pain. Chapter 2. European guidelines for prevention in low back pain : November 2004. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S136-68. doi: 10.1007/s00586-006-1070-3. No abstract available.

    PubMed 16550446

  • Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

    PubMed 6602967

  • Bhadauria EA, Gurudut P. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial. J Exerc Rehabil. 2017 Aug 29;13(4):477-485. doi: 10.12965/jer.1734972.486. eCollection 2017 Aug.

    PubMed 29114516

Questions about this trial

What is this clinical trial studying?

A study testing pressure biofeedback and core stabilization exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NPRS (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05021003, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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