NCT04555668

Brief Summary

The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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

January 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 16, 2020

Last Update Submit

September 16, 2020

Conditions

Keywords

Low Back PainOswestry Disability IndexNumeric Pain Rating ScaleStretch

Outcome Measures

Primary Outcomes (3)

  • Oswestry Disability Index (ODI)

    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. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. 0% to 20%: minimal disability 81%-100% exaggerating symptoms.

    6th week

  • Numeric Pain Rating Scale

    A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pai

    6th week

  • Goniometry

    A goniometer is an instrument which measures the available range of motion at a joint. A large Universal Goniometer having 12-inch arms and full-circle plastic body will be used for measuring Assisted Range of Motion (AROM) for hamstring length, it is a useful measurement tool that can be used to do the Active knee extension test. An active knee-extension test has been shown to be a reliable method of assessing hamstring tightness and has good intra-tester reliability \[intraclass correlation coefficient (ICC): 0.97-0.98\]

    6th week

Study Arms (2)

Global Postural Reeducation Program

EXPERIMENTAL

Global Postural Reeducation Program with hamstring stretch

Other: Global Postural Reeducation Program

Hamstring Stretch Program

ACTIVE COMPARATOR

Hamstring Stretch Program and Knee -flexor eccentric training

Other: Hamstring Stretch Program

Interventions

Global Postural Reeducation Program with hamstring stretch The lying posture with flexion of the legs aimed to stretch the posterior chain (upper trapezius, levator scapulae, sub occipital, erector spinae, gluteus maximus, ischio-tibial, triceps surae, and foot intrinsic muscles). The initial position will lying with the hip flexed and progression consisted of increasing hip flexion, knee extension, and dorsiflexion of the ankle All above exercises will be given and to be held for 15 minutes each. 40 min/session, 3 times/week for 6 weeks

Global Postural Reeducation Program

Hamstring Stretch Program 3 times for 30 seconds hold, subjects rested for 15 seconds between stretches. Knee -flexor eccentric training to prevent hamstring muscle strain 10-15 rep 40 min/session, 3 times/week for 6 weeks

Hamstring Stretch Program

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females
  • years
  • Low back pain \> 3 month
  • no exercise for last 6 months

You may not qualify if:

  • Any diagnosed pathology (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis)
  • Any lower limb abnormality
  • Congenital deformities
  • Central or peripheral neurologic signs
  • Systemic illness (tumor and rheumatologic diseases),
  • Psychiatric and mental deficits
  • Diabetic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping hand institute of rehabilitation sciences

Mānsehra, Khyber Pakhtunkhwa, Pakistan

Location

Related Publications (15)

  • Cuenca-Martinez F, Cortes-Amador S, Espi-Lopez GV. Effectiveness of classic physical therapy proposals for chronic non-specific low back pain: a literature review. Phys Ther Res. 2018 Mar 20;21(1):16-22. doi: 10.1298/ptr.E9937. eCollection 2018.

    PMID: 30050749BACKGROUND
  • da Silva DA, de Carvalho MEIM, de Andrade Mesquita LS. Effects of a protocol with manual therapy and postural techniques for non-specific low back pain. Manual Therapy, Posturology & Rehabilitation Journal. 2019;17:0-.

    BACKGROUND
  • Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.

    PMID: 19103627BACKGROUND
  • Parreira P, Maher CG, Steffens D, Hancock MJ, Ferreira ML. Risk factors for low back pain and sciatica: an umbrella review. Spine J. 2018 Sep;18(9):1715-1721. doi: 10.1016/j.spinee.2018.05.018. Epub 2018 May 21.

    PMID: 29792997BACKGROUND
  • Bento TPF, Genebra CVDS, Maciel NM, Cornelio GP, Simeao SFAP, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020 Jan-Feb;24(1):79-87. doi: 10.1016/j.bjpt.2019.01.012. Epub 2019 Feb 13.

    PMID: 30782429BACKGROUND
  • Abu-Naser SS, ALDAHDOOH R. Lower back pain expert system diagnosis and treatment. 2016.

    BACKGROUND
  • Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.

    PMID: 17350545BACKGROUND
  • Abdullah IB, Al-Mutairi MM, Alghubayan MA, Alamir AA, Bu-Jubarah AY, Almajed N, et al. Literature Review on Prevalence, Risk Factors and, Evaluation of Acute Lower Back Pain. International Journal of Pharmaceutical Research & Allied Sciences. 2020;9(1).

    BACKGROUND
  • Manchikanti L. Epidemiology of low back pain. Pain Physician. 2000 Apr;3(2):167-92.

    PMID: 16906196BACKGROUND
  • Brighton SW. The management of acute low back pain in adults: a guide for the primary care physician, Part II. South African Family Practice. 2013;55(1):26-32.

    BACKGROUND
  • Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.

    PMID: 30588084BACKGROUND
  • van Tulder MW, Malmivaara A, Esmail R, Koes BW. Exercise therapy for low back pain. Cochrane Database Syst Rev. 2000;(2):CD000335. doi: 10.1002/14651858.CD000335.

    PMID: 10796344BACKGROUND
  • Bonetti F, Curti S, Mattioli S, Mugnai R, Vanti C, Violante FS, Pillastrini P. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 16;11:285. doi: 10.1186/1471-2474-11-285.

    PMID: 21162726BACKGROUND
  • Guastala FAM, Guerini MH, Klein PF, Leite VC, Cappellazzo R, Facci LM. Effect of global postural re-education and isostretching in patients with nonspecific chronic low back pain: a randomized clinical trial. Fisioterapia em Movimento. 2016;29(3):515-25.

    BACKGROUND
  • Mistry GS, Vyas NJ, Sheth MS. Comparison of hamstrings flexibility in subjects with chronic low back pain versus normal individuals. J Clin Exp Res. 2014;2(1):85-8.

    BACKGROUND

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nazish Rafique, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 21, 2020

Study Start

January 15, 2020

Primary Completion

August 15, 2020

Study Completion

September 1, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations