NCT04206137

Brief Summary

The low back pain is a leading cause to limit individual functional activities worldwide and 60%-80% of adults are probable to get low back pain at least once in life time. Whereas, the chronic low back pain prevalence is 10%.The current literature suggests that any exercise is beneficial for reducing chronic nonspecific low back pain. This limits evidence regarding superiority of specific exercise for low back pain treatment. Therefore, a randomized control trial will be conducted at department of physiotherapy to assess which treatment is more effective in chronic low back pain at department of physiotherapy, institute of physical medicine and rehabilitation, Dow University of Health Sciences after synopsis approval. Overall 150 participants with 18-40 years old having chronic low back pain will be eligible and they will be included through non-probability, purposive sampling technique. The written informed consent will be taken from all the participants. They will be divided through systematic random sampling method into two groups, 75 in each group. Group A (experimental group) will receive Bilateral, asymmetrical limbs PNF pattern exercises and group B (control group) will receive Swiss ball exercises. All participants will be assessed using assessment form. Pain and functional disability will be measured by subjective outcome tools, visual analogue scale with 0-10cm and Oswestry disability index , respectively. Range of movement of lumbar and multifidus muscle activity will be measured by objective outcome tool, modified-modified Schober's test and surface electromyography, respectively. The pre \& post treatment outcomes will be collected and recorded. Treatment sessions will be given thrice a week for 5 weeks. A maximum drop-out rate of 20% is expected. The Mean ± SD will be calculated for quantitative variables and frequencies and percentages for qualitative variables. The recorded outcome variables before and after the five weeks of treatment will be compared and analysed. The p-value of 0.05 will be considered as level of significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2020

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

First Submitted

Initial submission to the registry

December 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

December 15, 2019

Last Update Submit

February 3, 2021

Conditions

Keywords

Muscle painLow Back DisorderExercisePhysical TherapySurface Electromyography

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale

    The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line. The scale is most commonly referred by "no pain" with score of 0 and "worst imaginable pain" with score of 100 on the scale. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.

    Change from baseline pain intensity at 5 weeks.

  • Modified Modified Schober's test.

    It is used during physical examination to assess the lumbar range of movement. It is highly co-related with lumbar range of movement measured through radiograph.

    Change from baseline lumbar range of movement at 5 weeks.

  • Surface electromyography

    It is a record of the electrical activity associated with muscular contraction. The electromyography is recorded and the peak amplitude \[maximal voluntary isometric contraction\] is selected manually and recorded.

    Change from baseline multifidus muscle activity at 5 weeks

Secondary Outcomes (1)

  • Oswestry Disability Index

    Change from baseline functional disability at 5 weeks

Study Arms (2)

Group A (PNF rhythmic initiation group )

EXPERIMENTAL

PNF rhythmic initiation with bilateral asymmetrical upper and lower limb pattern will administered on both sides, there will be 10 repetition and 3 sets for each side, 20 second rest between two sets.

Other: Group A (PNF rhythmic initiation group )

Group B (Swiss ball exercise group)

ACTIVE COMPARATOR

Swiss ball exercises will be administered. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set.

Other: Group B (Swiss ball exercises)

Interventions

Lifting of arms and push the head back through the pattern of flexion -abduction-external rotation and neck in extension to the left in opposition of therapist hand resistance will be asked to do. At the end range of motion extensor muscles of back will start to contract.Then, reversing of that movement pattern to extension-adduction-internal rotation and neck flexion to right against the therapist resisting hands will be asked. this will be repeated on both sides

Group A (PNF rhythmic initiation group )

Supine position: A ball will be placed under patient neck, and will be asked to bend hip and knee up to 90°. 5 times, 10 seconds hold Supine position: With a ball below the pelvis, knees bent, the ball press will be done with pelvis. 5 times, for 10 seconds hold. Crawling position: With a ball below one knee while keeping toes away from contact with the floor, the patient will balance first to stabilize the posture and slowly raise the other lower limb. This exercise will be performed in turn for the two lower limbs 10 times, with 10 seconds hold. Prone position: the patient will place a ball in front of pelvis and will repeatedly raise and lowered the two lower limbs alternately. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set.

Group B (Swiss ball exercise group)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic Low back pain (pain for \> 3 month)

You may not qualify if:

  • Any history related to spinal surgery
  • Previous administration of epidural injections.
  • Low Back Pain due to specific pathology,
  • Neurological deficits (like stroke)
  • Clinical disorder contraindicated to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aftab Ahmed Mirza Baig

Karachi, Sindh, Pakistan

Location

Related Publications (20)

  • Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.

    PMID: 28359011BACKGROUND
  • 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
  • Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.

    PMID: 26487293BACKGROUND
  • Baig AAM, Ahmed SI, Ali SS, Rahmani A, Siddiqui F. Role of posterior-anterior vertebral mobilization versus thermotherapy in non specific lower back pain. Pak J Med Sci. 2018 Mar-Apr;34(2):435-439. doi: 10.12669/pjms.342.12402.

    PMID: 29805422BACKGROUND
  • Metzger RL. Evidence-based practice guidelines for the diagnosis and treatment of lumbar spinal conditions. Nurse Pract. 2016 Dec 16;41(12):30-37. doi: 10.1097/01.NPR.0000508169.67852.bb.

    PMID: 27820593BACKGROUND
  • Minghelli B, Oliveira R, Nunes C. Non-specific low back pain in adolescents from the south of Portugal: prevalence and associated factors. J Orthop Sci. 2014 Nov;19(6):883-92. doi: 10.1007/s00776-014-0626-z. Epub 2014 Aug 22.

    PMID: 25145999BACKGROUND
  • Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.

    PMID: 29971708BACKGROUND
  • Wells C, Kolt GS, Marshall P, Bialocerkowski A. The definition and application of Pilates exercise to treat people with chronic low back pain: a Delphi survey of Australian physical therapists. Phys Ther. 2014 Jun;94(6):792-805. doi: 10.2522/ptj.20130030. Epub 2013 Oct 31.

    PMID: 24179139BACKGROUND
  • Luomajoki HA, Bonet Beltran MB, Careddu S, Bauer CM. Effectiveness of movement control exercise on patients with non-specific low back pain and movement control impairment: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2018 Aug;36:1-11. doi: 10.1016/j.msksp.2018.03.008. Epub 2018 Mar 28.

    PMID: 29631119BACKGROUND
  • Areeudomwong P, Buttagat V. Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2019 Sep-Oct;23(5):428-436. doi: 10.1016/j.bjpt.2018.10.005. Epub 2018 Oct 17.

    PMID: 30361077BACKGROUND
  • Lee CW, Hwangbo K, Lee IS. The effects of combination patterns of proprioceptive neuromuscular facilitation and ball exercise on pain and muscle activity of chronic low back pain patients. J Phys Ther Sci. 2014 Jan;26(1):93-6. doi: 10.1589/jpts.26.93. Epub 2014 Feb 6.

    PMID: 24567683BACKGROUND
  • French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004750. doi: 10.1002/14651858.CD004750.pub2.

    PMID: 16437495BACKGROUND
  • Noormohammadpour P, Kordi M, Mansournia MA, Akbari-Fakhrabadi M, Kordi R. The Role of a Multi-Step Core Stability Exercise Program in the Treatment of Nurses with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial. Asian Spine J. 2018 Jun;12(3):490-502. doi: 10.4184/asj.2018.12.3.490. Epub 2018 Jun 4.

    PMID: 29879777BACKGROUND
  • Shah SG, Kage V. Effect of Seven Sessions of Posterior-to-Anterior Spinal Mobilisation versus Prone Press-ups in Non-Specific Low Back Pain - Randomized Clinical Trial. J Clin Diagn Res. 2016 Mar;10(3):YC10-3. doi: 10.7860/JCDR/2016/15898.7485. Epub 2016 Mar 1.

    PMID: 27134987BACKGROUND
  • Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.

    PMID: 27081203BACKGROUND
  • Kumar T, Kumar S, Nezamuddin M, Sharma VP. Efficacy of core muscle strengthening exercise in chronic low back pain patients. J Back Musculoskelet Rehabil. 2015;28(4):699-707. doi: 10.3233/BMR-140572.

    PMID: 25467999BACKGROUND
  • Jeong JK, Kim YI, Kim E, Kong HJ, Yoon KS, Jeon JH, Kang JH, Lee H, Kwon O, Jung SY, Han CH. Effectiveness and safety of acupotomy for treating back and/or leg pain in patients with lumbar disc herniation: A study protocol for a multicenter, randomized, controlled, clinical trial. Medicine (Baltimore). 2018 Aug;97(34):e11951. doi: 10.1097/MD.0000000000011951.

    PMID: 30142818BACKGROUND
  • Nowotny AH, Calderon MG, de Souza PA, Aguiar AF, Leonard G, Alves BMO, Amorim CF, da Silva RA. Lumbar stabilisation exercises versus back endurance-resistance exercise training in athletes with chronic low back pain: protocol of a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Nov 22;4(1):e000452. doi: 10.1136/bmjsem-2018-000452. eCollection 2018.

    PMID: 30555717BACKGROUND
  • Chung S, Lee J, Yoon J. Effects of stabilization exercise using a ball on mutifidus cross-sectional area in patients with chronic low back pain. J Sports Sci Med. 2013 Sep 1;12(3):533-41. eCollection 2013.

    PMID: 24149162BACKGROUND
  • Baig AAM, Ansari B. Bilateral Asymmetrical Limb Proprioceptive Neuromuscular Facilitation Effects on Pain, Multifidus Activity, Range of Motion, and Disability in Low Back Pain: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2022 Oct;45(8):604-613. doi: 10.1016/j.jmpt.2023.04.005. Epub 2023 Jun 9.

Related Links

MeSH Terms

Conditions

Low Back PainMyalgiaMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainBehavior

Study Officials

  • Aftab Ahmed Mirza Baig, MSAPT

    University of Karachi

    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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 20, 2019

Study Start

March 3, 2020

Primary Completion

December 15, 2020

Study Completion

January 17, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations