NCT04559477

Brief Summary

This study will help to find the effects of static and dynamic back extensors exercises for chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 16, 2020

Last Update Submit

September 16, 2020

Conditions

Keywords

Low Back PainEnduranceStaticDynamicExercisesPain

Outcome Measures

Primary Outcomes (5)

  • Roland-Morris Disability Questionnaire

    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability

    6th week

  • Modified Biering-Sorensen test of Static Muscular Endurance (BSME)

    The BSME is used to assess the static back endurance. During the test the participant lay down on the plinth in the prone position with the upper edge of the iliac crests aligned with the edge of the plinth with their hands held by their sides. The lower body is fixed to the plinth by two non elastic straps located around the pelvis and ankles. Horizontality in the test position is ensured by asking the participant to maintain contact between his/her back and a hanging weighted ball. Once a loss of contact for more than 10 seconds is noticed, the participant is encouraged once to immediately maintain contact again. Once the participant could not immediately correct or hold the position or claimed to be fatigued the test is terminated. This test is time based, as long as the patient hold the position

    6th week

  • Repetitive Arch-Up Test (RAUT)

    Repetitive Arch-Up Test (RAUT) is used to assess the static back endurance. During the test, the participant lay in a prone position on the plinth with the arms positioned along the sides. The iliac crest is positioned at the edge of the plinth. The lower body is fixed to the plinth by two nonelastic straps located around the pelvis and ankles. With the arms held along the sides touching the body, the subject was asked to flex the upper trunk downward to 45∘ as indicated by a board. The participant then raised the upper trunk upwards to the horizontal position followed by returning back downward to 45 degrees to complete a cycle. The repetition rate is one repetition per two to three seconds. Once the movement becomes jerky or nonsynchronous, or do not reach the horizontal level, the subject is encouraged once to immediately correct the motion again. The test is terminated once the participant could not go on with the tempo of the motion or reported fatigue or exhaustion.

    6th week

  • Numeric Pain Rating Scale (NPRS)

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. '0' usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible

    6th week

  • Oswestry Disability Index (ODI),

    Oswestry Disability Index is used to assess pain-related disability in persons with low back pain (LBP). The (ODI) is calculated based on each score of the ODQ, which consists of ten items. Each of the ten items is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP

    6th week

Study Arms (2)

Static extension endurance exercise

EXPERIMENTAL

static back extension endurance exercise

Other: Static extension endurance exercise

Dynamic extension endurance exercise

ACTIVE COMPARATOR

dynamic back extension endurance exercise

Other: Dynamic extension endurance exercise

Interventions

Static extension endurance exercise were performed, 10 repetitions with 10 sec hold of each of exercises Heating pad:15 mins TENS: 15 mins 35 min/session, 3 sessions/week for 6 weeks

Static extension endurance exercise

Dynamic extension endurance exercise with 10 repetitions of each of exercises which has been performed Heating pad:15 mins TENS: 15 mins 35 min/session, 3 sessions/week for 6 weeks

Dynamic extension endurance exercise

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales are included in the study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females
  • years
  • Low back pain \> 3 month
  • Postural dysfunction

You may not qualify if:

  • Red flags indicative of serious spinal pathology with signs and symptoms of nerve root compromise (with at least two of dermatomal sensory loss, myotomal muscle weakness and reduced lower limb reflexes)
  • Individuals with any obvious spinal deformity or neurological disease;
  • Pregnancy
  • Previous spinal surgery
  • Previous experience of static and dynamic endurance exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Headquater hospital

Mirpur Mathelo, Mirpur Azad Kashmir, Pakistan

Location

Related Publications (10)

  • Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.

    PMID: 23245607BACKGROUND
  • Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.

    PMID: 27408698BACKGROUND
  • Mbada CE, Ayanniyi O, Ogunlade SO. Effect of static and dynamic back extensor muscles endurance exercise on pain intensity, activity limitation and participation restriction in patients with long-term mechanical low-back pain. Med Rehabil. 2011;15(3):11-20.

    BACKGROUND
  • Mbada CE, Ayanniyi O, Ogunlade SO, Orimolade EA, Oladiran AB, Ogundele AO. Influence of Mckenzie protocol and two modes of endurance exercises on health-related quality of life of patients with long-term mechanical low-back pain. Pan Afr Med J. 2014 Jan 18;17 Suppl 1(Suppl 1):5. doi: 10.11694/pamj.supp.2014.17.1.2950. eCollection 2014.

    PMID: 24624241BACKGROUND
  • Tanvi A, Shalini G, Parul R, Gaurav S. Effect of proprioceptive neuromuscular facilitation program on muscle endurance, strength, pain, and functional performance in women with post-partum lumbo-pelvic pain. IOSR J Dent Med Sci. 2013;7:60-7.

    BACKGROUND
  • Doo YT, Eom WS. Effect of Short Term Static• Dynamic Lumbar Stability Exercise on the Trunk Muscles Strength and Endurance of Chronic Low Back Pain Female College Students in Their 20's. The Official Journal of the Korean Academy of Kinesiology. 2016 May 31;18(2):63-9.

    BACKGROUND
  • Mayer JM, Childs JD, Neilson BD, Chen H, Koppenhaver SL, Quillen WS. Effect of Lumbar Progressive Resistance Exercise on Lumbar Muscular Strength and Core Muscular Endurance in Soldiers. Mil Med. 2016 Nov;181(11):e1615-e1622. doi: 10.7205/MILMED-D-15-00543.

    PMID: 27849497BACKGROUND
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    BACKGROUND
  • Alcántara-Bumbiedro S, Flórez-García MT, Echávarri-Pérez C, García-Pérez F. Oswestry low back pain disability questionnaire. REHABILITACION-MADRID-. 2006;40(3):150.

    BACKGROUND
  • Grotle M, Brox JI, Vollestad NK. Cross-cultural adaptation of the Norwegian versions of the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. J Rehabil Med. 2003 Sep;35(5):241-7. doi: 10.1080/16501970306094.

    PMID: 14582557BACKGROUND

Related Links

MeSH Terms

Conditions

Back PainLow Back PainMotor ActivityPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

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 22, 2020

Study Start

February 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 30, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations