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Low Back PainNCT05780593

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

A study testing Manual Therapy and Inclined Board Standing in people with Low Back Pain, run by Agile Institute of Rehabilitation Sciences 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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
Manual Therapy and Inclined Board Standing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
22 Mar 2023to 27 Jun 2023
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Agile Institute of Rehabilitation Center

    Chak Eighty-seven -Twelve Left, Punjab Province, 63100

Other trials in Pakistan

About this study

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.

Read the detailed description

Manual therapy is a sub-type of physical therapy that uses hands-on maneuver to diagnose and treat musculoskeletal pain and dysfunction. Mobilization and manipulation are widely used for the management of low-back-pain (LBP), a common and debilitating condition that affects millions of people worldwide. The goal of manual therapy is to improve mobility, reduce pain and discomfort, and enhance functional capacity. Evidence is growing now a days that is in the direction of usage of manual therapy for the treatment of the lower back pain. Many studies have demonstrated the effectiveness of manual-therapy procedures such as spinal high velocity low amplitude thrust, low velocity and high intensity joint passive movement, and massage in alleviating pain and dysfunction and enhancing physical and mental functions in clinical cases with lower backache.

The prime purpose of this research aimed to investigate the relationship between the length of the tensor fasciae lata (TFL) and pelvic rotation during one-leg stance in healthy adults. 41 participants were assessed using a 3-dimensional motion analyzer, and their TFL length and hip rotation range of motion were measured. The results divided participants into two groups based on their pelvic rotation during one-leg stance. Although there was no significant difference in TFL length between the two groups, the study suggests that pelvic instability may cause trunk instability during one-leg stance.

Another study looked at static balance in three different standing positions with and without a foam surface. It found that standing over slanted surfaces increased postural unsteadiness, and that dorsiflexed ankles over a foam surface created more postural instability.

To create a human-like biped posture, a study created a Neural Controllable (NC) model to represent a human-like biped posture. The model generated physiologically reasonable muscle activations and captured the idea that individuals choose a low active stiffness level while standing to use less energy.

Another researcher reviewed the involvement of the "kinetic chain" in overhead athletes and applied it to clinical workout adjustments for the prevention and treatment of shoulder injuries. The study found that lower extremities, trunk, and scapular area all play a role in the formation of adequate terminal segment acceleration during overhead throwing and serving actions. The study suggests that traditional shoulder exercises should include scapular stabilizer and core musculature activation in addition to rotator cuff activation.

Research Gap:

Low-back-pain (LBP) is a Musculo-skeletal ailment that has a negative societal impact and is extremely common around the world, causing disability. LBP is one of the most common reasons people seek medical attention in the United States, along with neck pain, which is connected with the greatest healthcare expenses. Surgical patients are the most expensive per care episode, however the vast majority of lower backache management spending can be attributable to the substantially higher number of non-operative care episodes.

In 2021, Academy of Orthopedic Physical Therapy (AOPT) has published updated Clinical Practice Guidelines (CPG) for acute and chronic low-back-pain linked to the ICF model for physical therapists The updated Clinical Practice Guidelines (CPGs) for the treatment of lower back pain (LBP) recommend four interventional categories: exercise, manual and other-directed therapies, classification systems, and patient education. The guidelines were developed to be applicable globally and acknowledge that differences in factors such as healthcare systems, cultural norms, and social health determinants may impact the implementation of these recommendations. Physical therapists are the primary audience, but other stakeholders may also find the guidelines useful. The CPG update has identified knowledge gaps in the treatment of LBP and recommended further research using Single Level I RCT or Small-Sample Level II RCTs With Short Follow-up Times to develop better and cost-effective management approaches.

Conditions
Low Back Pain
Being tested
Manual Therapy, Inclined Board Standing
Keywords
Low Back Pain, Manual Therapy, Passive Stretching, Inclined Board Standing
Medical subject headings
Low Back Pain

What participants receive

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

  • Manual TherapyOther

    Also called Passive Stretching, Inclined Board Standing

    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.

  • Inclined Board StandingOther

    Also called Routine medications(if any)

    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.

Study groups in NCT05780593
Study groupRoleWhat they receive
Intervention Group AExperimentalManual mobilization of lumbosacral spine along with passive stretching of the hip abductors and 01 minute of inclined board standing for 03 times a day.
Receives: Other: Manual Therapy; Other: Inclined Board Standing
Intervention Group BExperimentalRoutine medications(if any) along with 01 minute of inclined board standing for 03 times a day.
Receives: Other: Inclined Board Standing

What is being measured

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

  1. NEUMERIC PAIN RATING SCALE (NPRS)

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

    Measured: 03 Months

Secondary outcomes (2)

  1. Oswestry-Disability-Index (ODI)

    The ODI was established in English and has now been translated into over 40 languages. It was developed to measure the low back pain and disability over time. It consists of 10, with five-part sections. At the last, score is calculated by dividing the obtained score by total (50) multiplied by 100.

    Measured: 03 Months

  2. Short-form-12 questionnaire (SF-12)

    The Medical Outcomes Study (MOS), a multi-year study of patients with chronic illnesses, developed the 12-item Short Form Health Survey (SF-12). The SF-12 is a general HRQoL assessment that assesses general health status in eight dimensions (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health).

    Measured: 03 Months

Timeline

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

  1. First posted22 Mar 2023
  2. Study start22 Mar 2023
  3. Primary completion14 Apr 2023
  4. Study completion27 Jun 2023

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
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780593
Sponsor's protocol ID
AgileRehab
Status last verified
Jul 2023
First submitted
13 Mar 2023
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 16550448

  • 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.

    PubMed 31972537

  • 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.

  • 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.

    PubMed 28122885

  • 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.

    PubMed 29034802

  • 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.

    PubMed 19027342

  • 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.

    PubMed 26401979

  • 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.

    PubMed 28666405

  • 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.

    PubMed 29573871

  • 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.

    PubMed 25841358

  • 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.

    PubMed 21856077

  • 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.

    PubMed 22231424

  • 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.

    PubMed 33892801

  • 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.

    PubMed 31064375

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy and Inclined Board Standing in people with Low Back Pain, run by Agile Institute of Rehabilitation Sciences 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 3 inclusion and 2 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 25 Jul 2023. 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?

NEUMERIC PAIN RATING SCALE (NPRS) (time frame: 03 Months). 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 NCT05780593, which also lists 20 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 25 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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