NCT05207605

Brief Summary

Non-specific low back pain is defined as low back pain not attributable to an identifiable, known specific pathology. Non-specific low back pain accounts for over 90% of patients presenting to primary care and these are the majority of the individuals with low back pain that present to physiotherapy.Objective of this study is to compare the effects of rhythmic stabilization and McKenzie technique on pain and function in patients with non-specific chronic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

December 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

January 24, 2022

Last Update Submit

November 10, 2023

Conditions

Keywords

non specific low back painparaspinal muscles

Outcome Measures

Primary Outcomes (2)

  • Numerical Rating Scale (NPRS)

    Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in low back pain (LBP).The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)

    4th week

  • Oswestery 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. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound

    4th week

Secondary Outcomes (3)

  • ROM lumber spine (flexion)

    4th week

  • ROM lumber spine (extension)

    4th week

  • ROM lumber spine (side flexion)

    4th week

Study Arms (2)

Rhythmic Stabilization (RS)

EXPERIMENTAL

The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended

Other: Rhythmic Stabilization (RS)

McKenzie technique

EXPERIMENTAL

McKenzie exercises will be guided to conduct four extension exercises and three flexion exercises.

Other: McKenzie technique

Interventions

Group A includes rhythmic stabilization technique. The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended. Subjects performed 3 sets of 15 repetitions at maximal resistance provided by the same physical therapist. Rest intervals of 30 seconds and 60 seconds were provided after the completion of 15 repetitions for each pattern and between sets, respectively. The total duration of RS will be of approximately 33 minutes

Rhythmic Stabilization (RS)

McKenzie technique will be guided to conduct four extension exercises and three flexion exercisesAll flexion exercises will be repeated for ten repetitions for two sets. There are three minutes for resting intervals in every set. The McKenzie treatment will lasted for 20-40 minutes.

McKenzie technique

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • NSCLBP patients aged ≥ 18 to 45 years old(23).
  • Both genders.
  • Mild to moderate back pain with NPRS pain score value of between 2/10 - 6/10.
  • Pain from at least past three months (12 weeks).
  • No radiating pain below the gluteal fold.

You may not qualify if:

  • Diagnosis of systemic metabolic and/or neurological disorder.
  • Neuropathic pain.
  • Any referred pain below gluteal fold or neurological involvement in lower limbs is not included.
  • Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolysthesis, and spondylitis and other medical illnesses such as tumor, kidney disease, and visceral disease that can be related with low back pain excluded in this study.
  • Participants who had undergone surgery for LBP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Luz Junior MAD, Almeida MO, Santos RS, Civile VT, Costa LOP. Effectiveness of Kinesio Taping in Patients With Chronic Nonspecific Low Back Pain: A Systematic Review With Meta-analysis. Spine (Phila Pa 1976). 2019 Jan 1;44(1):68-78. doi: 10.1097/BRS.0000000000002756.

    PMID: 29952880BACKGROUND
  • Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.

    PMID: 28874980BACKGROUND
  • Citko A, Gorski S, Marcinowicz L, Gorska A. Sedentary Lifestyle and Nonspecific Low Back Pain in Medical Personnel in North-East Poland. Biomed Res Int. 2018 Sep 9;2018:1965807. doi: 10.1155/2018/1965807. eCollection 2018.

    PMID: 30271778BACKGROUND
  • Yang JH, Suk KS, Lee BH, Jung WC, Kang YM, Kim JH, Kim HS, Lee HM, Moon SH. Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials. Yonsei Med J. 2017 May;58(3):637-643. doi: 10.3349/ymj.2017.58.3.637.

    PMID: 28332372BACKGROUND
  • Iizuka Y, Iizuka H, Mieda T, Tsunoda D, Sasaki T, Tajika T, Yamamoto A, Takagishi K. Prevalence of Chronic Nonspecific Low Back Pain and Its Associated Factors among Middle-Aged and Elderly People: An Analysis Based on Data from a Musculoskeletal Examination in Japan. Asian Spine J. 2017 Dec;11(6):989-997. doi: 10.4184/asj.2017.11.6.989. Epub 2017 Dec 7.

    PMID: 29279756BACKGROUND
  • Imamura M, Alfieri FM, Filippo TR, Battistella LR. Pressure pain thresholds in patients with chronic nonspecific low back pain. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):327-336. doi: 10.3233/BMR-150636.

    PMID: 26406214BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sana Hafeez, PhD*

    Riphah International University Lahore Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

January 26, 2022

Study Start

December 2, 2021

Primary Completion

June 12, 2022

Study Completion

July 4, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations