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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04559477
Other study ID # REC/00236 Ayesha Jamal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date August 30, 2020

Study information

Verified date September 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Low back pain (LBP) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. Determine the effects of static and dynamic back extensors exercises for chronic low back pain.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 30, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria:

- Females

- 25-55 years

- Low back pain > 3 month

- Postural dysfunction

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Static extension endurance exercise
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
Dynamic 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

Locations

Country Name City State
Pakistan District Headquater hospital Mirpur Mirpur Azad Kashmir

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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

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. Version 2. F1000Res. 2016 Jun 28 [revised 2016 Jan 1];5. pii: F1000 Faculty Rev-1530. eCollection 2016. Review. — View Citation

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.

Grotle M, Brox JI, Vøllestad 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. — View Citation

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. — View Citation

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 1:5. doi: 10.11694/pamj.supp.2014.17.1.2950. eCollection 2014. — View Citation

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.

McCaffery M, Beebe A. The numeric pain rating scale instructions. InPain: Clinic Manual for Nursing Practice 1989. Mosby, St. Louis.

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.

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, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé 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, Fèvre 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 Leòn 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. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added]. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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