Effects of Manual Therapy and Inclined Board Standing on Low Back Pain

NCT05780593 | Completed

• 1 other identifier: AgileRehab
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To date, there have been limited clinical trials conducted to determine the effects of manual therapy combined with passive stretching and inclined board standing for treating low-back pain. This will be the first randomized controlled trial to evaluate the effects of these integrated interventions. The study aims to develop a new approach towards the cost-effective management of low-back pain, in line with the World Health Organization's (WHO) vision of maximizing health outcomes, preventing disability, and reducing the cost of care.

Conditions

Low Back Pain

Keywords

Low Back Pain; Manual Therapy; Passive Stretching; Inclined Board Standing

Outcome Measures

Primary Outcomes (1)

• NEUMERIC PAIN RATING SCALE (NPRS)

  Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.

  03 Months

Secondary Outcomes (2)

• Oswestry-Disability-Index (ODI)

  03 Months

• Short-form-12 questionnaire (SF-12)

  03 Months

Study Arms (2)

Intervention Group A

EXPERIMENTAL

Manual mobilization of lumbosacral spine along with passive stretching of the hip abductors and 01 minute of inclined board standing for 03 times a day.

Other: Manual Therapy; Other: Inclined Board Standing

Intervention Group B

EXPERIMENTAL

Routine medications(if any) along with 01 minute of inclined board standing for 03 times a day.

Other: Inclined Board Standing

Interventions

Manual Therapy OTHER

After the baseline assessment, each intervention group will be given physical therapy treatment. The group A will receive Manual Mobilization of the Lumbosacral Spine followed by passive stretching of the hip abductors of both sides of the body. The patient then will be asked to stand on the inclined board for 01 minute with feet 3 to 4 inches apart hands placed on the wall at the level of shoulder joints. After 01-minute patient will be asked to leave the inclined board. The patient will be advised to do this 01-minute inclined board standing for three times a day at home. All the patients in Group A will receive this treatment regime for two weeks.

Also known as: Passive Stretching, Inclined Board Standing

Intervention Group A

Inclined Board Standing OTHER

The patients in Group B will be asked to stick to their medications if advised and stand on the inclined board for 01 minute. Inclined boards will be provided to all patients and will be advised to follow the inclined standing for 01 minute for three times a day at home for two weeks. After two weeks at the completion of intervention, they will be assessed through self-reporting questionnaires of the study.

Also known as: Routine medications(if any)

Intervention Group A; Intervention Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are capable of receiving the treatment thrice a week willingly for maximum of 60 minutes.
• Persistent low back pain that has lasted more than three months with no evidence of improvement, with or without discomfort into the lower limbs.
• Low back pain on Numerical Pain Rating scale of at least 2/10 and less or equal to 9/10. Age 18-65 years

You may not qualify if:

• No informed consent Pregnancy reported by the patient Prior surgical history of spine Previously diagnosed inflammatory joint disease. Warning complaints diagnosed by therapist. These cases were referred for lab investigation.
• Motor or sensory neurological signs Cases of low-back-pain are not compliant with the exercise program. Previously or currently indulge in the exercise plan or physical fitness plan

Sponsors & Collaborators

• Agile Institute of Rehabilitation Sciences: lead

Study Sites (1)

Agile Institute of Rehabilitation Center

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

Location

Related Publications (20)

• Adams, M. A., Bogduk, N., Burton, K., & Dolan, P. (2012). The Biomechanics of Back Pain-E-Book: Elsevier health sciences.

  BACKGROUND

• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• Alwadani FA, Liang H, Aruin AS. Effects of Ankle Angular Position and Standing Surface on Postural Control of Upright Stance. Motor Control. 2020 Jan 23;24(2):291-303. doi: 10.1123/mc.2019-0079.

  PMID: 31972537 BACKGROUND

• Azevedo, R., Johnson, A., & Burkett, C. (2015). Does Training of Cognitive and Metacognitive Regulatory Processes Enhance Learning and Deployment of Processes with Hypermedia? Paper presented at the CogSci.

  BACKGROUND

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Bialosky JE, Beneciuk JM, Bishop MD, Coronado RA, Penza CW, Simon CB, George SZ. Unraveling the Mechanisms of Manual Therapy: Modeling an Approach. J Orthop Sports Phys Ther. 2018 Jan;48(1):8-18. doi: 10.2519/jospt.2018.7476. Epub 2017 Oct 15.

  PMID: 29034802 BACKGROUND

• Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

  PMID: 19027342 BACKGROUND

• Bishop MD, Torres-Cueco R, Gay CW, Lluch-Girbes E, Beneciuk JM, Bialosky JE. What effect can manual therapy have on a patient's pain experience? Pain Manag. 2015;5(6):455-64. doi: 10.2217/pmt.15.39. Epub 2015 Sep 24.

  PMID: 26401979 BACKGROUND

• Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.

  PMID: 28666405 BACKGROUND

• Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.

  PMID: 29573871 BACKGROUND

• Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CW, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Ostelo RW. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015 Jun;24(6):1127-42. doi: 10.1007/s00586-015-3892-3. Epub 2015 Apr 5.

  PMID: 25841358 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 BACKGROUND

• Haddad C, Sacre H, Obeid S, Salameh P, Hallit S. Validation of the Arabic version of the "12-item short-form health survey" (SF-12) in a sample of Lebanese adults. Arch Public Health. 2021 Apr 23;79(1):56. doi: 10.1186/s13690-021-00579-3.

  PMID: 33892801 BACKGROUND

• Hall AM, Scurrey SR, Pike AE, Albury C, Richmond HL, Matthews J, Toomey E, Hayden JA, Etchegary H. Physician-reported barriers to using evidence-based recommendations for low back pain in clinical practice: a systematic review and synthesis of qualitative studies using the Theoretical Domains Framework. Implement Sci. 2019 May 7;14(1):49. doi: 10.1186/s13012-019-0884-4.

  PMID: 31064375 BACKGROUND

• Hultman G, Saraste H, Ohlsen H. Anthropometry, spinal canal width, and flexibility of the spine and hamstring muscles in 45-55-year-old men with and without low back pain. J Spinal Disord. 1992 Sep;5(3):245-53. doi: 10.1097/00002517-199209000-00001.

  PMID: 1387820 BACKGROUND

• Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.

  PMID: 9243433 BACKGROUND

• Kim DH, Park JK, Jeong MK. Influences of posterior-located center of gravity on lumbar extension strength, balance, and lumbar lordosis in chronic low back pain. J Back Musculoskelet Rehabil. 2014;27(2):231-7. doi: 10.3233/BMR-130442.

  PMID: 24284274 BACKGROUND

• Negrini S, Giovannoni S, Minozzi S, Barneschi G, Bonaiuti D, Bussotti A, D'Arienzo M, Di Lorenzo N, Mannoni A, Mattioli S, Modena V, Padua L, Serafini F, Violante FS. Diagnostic therapeutic flow-charts for low back pain patients: the Italian clinical guidelines. Eura Medicophys. 2006 Jun;42(2):151-70. No abstract available.

  PMID: 16767064 BACKGROUND

• Vincent-Onabajo GO, Nweze E, Kachalla Gujba F, Ali Masta M, Usman Ali M, Alhaji Modu A, Umeonwuka C. Prevalence of Low Back Pain among Undergraduate Physiotherapy Students in Nigeria. Pain Res Treat. 2016;2016:1230384. doi: 10.1155/2016/1230384. Epub 2016 Feb 3.

  PMID: 26955486 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Muhammad Hafeez

  Agile Institute of Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

• Muhammad Hafeez

  The Islamia University of Bahawalpur

  STUDY CHAIR

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

Model Details: Two arm parallel research involves two groups randomized into Interventional Group-A and Interventional Group-B. The unit of randomization will be Agile Institute of Rehabilitation Sciences. This study will use 2 (between groups: Effects of mobilization with passive stretching of lateral rotators along with inclined board standing vs Inclined board standing) ×3 (time: before vs. after vs. 4 weeks after follow-up) mixed design to measure the effects of mobilization, passive stretching of hip abductors and inclined board standing on low back patient.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: March 22, 2023
• Primary Completion: April 14, 2023
• Study Completion: June 27, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)