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Back PainNCT04559477

Comparison of Static & Dynamic Back Extensor Endurance Exercises in LBP

A study testing Static extension endurance exercise and Dynamic extension endurance exercise in people with Back Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 25 to 55 years, women only
Conditions the study is for
Back Pain
What is being tested?
Static extension endurance exercise and Dynamic extension endurance exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 sitePakistan
Study dates
1 Feb 2020to 30 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females
  • 25-55 years
  • Low back pain > 3 month
  • Postural dysfunction

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • District Headquater hospital

    Mirpur Mathelo, Mirpur Azad Kashmir

Other trials in Pakistan

About this study

Official title: Comparison of Static & Dynamic Back Extensor Endurance Exercises For Chronic Low Back Pain

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

Read the detailed 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.

Conditions
Back Pain
Being tested
Static extension endurance exercise, Dynamic extension endurance exercise
Keywords
Low Back Pain, Endurance, Static, Dynamic, Exercises, Pain
Medical subject headings
Back Pain, Low Back Pain, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Static extension endurance exerciseOther

    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 exerciseOther

    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

Study groups in NCT04559477
Study groupRoleWhat they receive
Static extension endurance exerciseExperimentalstatic back extension endurance exercise
Receives: Other: Static extension endurance exercise
Dynamic extension endurance exerciseActive comparatordynamic back extension endurance exercise
Receives: Other: Dynamic extension endurance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6th week

  2. 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

    Measured: 6th week

  3. 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.

    Measured: 6th week

  4. 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

    Measured: 6th week

  5. 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

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start1 Feb 2020
  3. Primary completion1 Aug 2020
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559477
Sponsor's protocol ID
REC/00236 Ayesha Jamal
Status last verified
Sep 2020
First submitted
16 Sep 2020
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23245607

  • 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.

    PubMed 27408698

  • 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.

  • 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.

    PubMed 24624241

  • 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.

  • 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.

  • 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.

    PubMed 27849497

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

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

  • 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.

    PubMed 14582557

Questions about this trial

What is this clinical trial studying?

A study testing Static extension endurance exercise and Dynamic extension endurance exercise in people with Back Pain, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland-Morris Disability Questionnaire (time frame: 6th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559477, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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