NCT07098741

Brief Summary

Anterior pelvic tilt (APT) is a prevalent postural deviation characterized by excessive forward rotation of the pelvis, often resulting in increased lumbar lordosis. This condition is frequently associated with non-specific low back pain (NSLBP), which affects a significant portion of the global population and poses substantial challenges for individuals' well-being and healthcare systems worldwide. NSLBP is a multifactorial condition with various etiological factors, including poor posture, muscle imbalances, sedentary lifestyle, and biomechanical abnormalities such as APT. Understanding and effectively managing APT in the context of NSLBP is crucial for reducing pain, improving functional capacity, and enhancing quality of life for affected individuals . Despite the prevalence and clinical significance of APT in NSLBP, there is a lack of comprehensive research comparing the effectiveness of different therapeutic interventions. Various approaches have been proposed, including core stability exercises, soft tissue release with manual therapy, stretching and flexibility exercises, and postural correction exercises . However, the relative efficacy of these interventions remains uncertain, hindering evidence-based decision-making in clinical practice. A variety of therapeutic interventions have been proposed for managing APT and NSLBP, aiming to address underlying biomechanical imbalances, improve musculoskeletal function, and alleviate pain. Core stability exercises, focused on strengthening the deep stabilizing muscles of the spine and pelvis, have shown promise in improving postural alignment and reducing NSLBP symptoms. Soft tissue release techniques, such as manual therapy and myofascial release, target tight and restricted muscles associated with APT, promoting relaxation and improved range of motion. Stretching and flexibility exercises aim to elongate tight musculature, particularly in the hip flexors and lumbar extensors, thereby reducing excessive pelvic tilt and alleviating NSLBP. Additionally, postural correction exercises focus on retraining optimal alignment and body mechanics, promoting a more neutral pelvic position and reducing strain on the lumbar spine.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 19, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

physiotherapy interventionsNon specific low back painanterior pelvic tiltlow back pain treatment

Outcome Measures

Primary Outcomes (2)

  • APT angle

    Anterior pelvic tilt angle will be assessed before, at mid and at end of interventions

    4 weeks

  • Pain

    Pain severity will be assessed using Numeric Pain Rating Scale NPRS. NPRS measures the pain severity quantitatively having zero "0" as no pain at one end and "10" as the worst ever pain at the other end. Higher the score on NPRS, more severe the pain and vice versa.

    4weeks

Secondary Outcomes (1)

  • Balance

    4 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Core stability exercises with electrotherapy group.

Other: Core stability exercises with electrotherapy

Group B

EXPERIMENTAL

Soft tissue release with manual therapy and stretching group.

Other: Soft tissue release with manual therapy and stretching

Group C

EXPERIMENTAL

Postural correction exercises with contrast therapy group.

Other: Postural correction exercises with contrast therapy

Group D

EXPERIMENTAL

(Control group) combination of electrotherapy with stretching and flexibility exercises group.

Other: combination of electrotherapy with stretching and flexibility exercises

Interventions

electrotherapy modalities for pain control will be used and exercises strengthening abdominal core muscles will be applied in two phases.

Group A

Manual soft tissue release will be performed and then stretching of back muscles and thigh muscles will be added to treatemnet.

Group B

Hot and cold packs will be used one after other for 10-15mins and specific exercises which are designed to improve posture will be taught and performed

Group C

some pain reducing electrotherapy modality like TENS will be used and general stretching and flexibility exercises will be performed

Group D

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: Participants must be between 20 and 40 years old.
  • Gender: Both genders, Male and Female have equal chance of selection as participant in the study.
  • Diagnosis: Participants must have a confirmed diagnosis of non-specific low back pain (NSLBP), altered lumbar posture, restricted range of motion of lumbar spine due to muscular spasm etc., altered anterior pelvic tilt angle by a qualified healthcare professional, based on standardized diagnostic criteria (e.g., clinical examination, imaging studies).
  • Confirmation of Anterior Pelvic Tilt (APT): Participants exhibiting APT confirmed through physical assessment by a trained examiner. This confirmation will involve the use of standardized measures such as digital inclinometers or goniometers.
  • Severity: Participants should have mild to moderate symptoms of non-specific low back pain (NSLBP) specially pain, as determined by the assessing healthcare provider.
  • Physical Capability: Participants who are physically capable of performing the prescribed exercises and interventions without significant limitations.
  • Consent: Participants who provide informed consent to participate in the study after receiving detailed information about the study objectives, procedures, potential risks, and benefits.
  • Compliance: Participants who are willing and able to comply with the study procedures, including attending scheduled sessions, adhering to the intervention protocols, and completing required assessments.
  • No Concurrent Treatment: Participants who have not undergone any concurrent treatments specifically targeting APT or low back pain during the study period to avoid confounding effects.

You may not qualify if:

  • Trauma or Fracture: Individuals with a history of trauma or fracture around the pelvic and lumbar region, as this may significantly affect the participant's ability to perform the prescribed exercises and interventions and confound study outcomes.
  • Orthopedic or Neurological Surgery: Participants with a history of orthopedic or neurological surgery related to the pelvic or lumbar region, as this may impact the participant's musculoskeletal function and response to the interventions.
  • Malignancy: Individuals with a diagnosis of malignancy, as this may introduce confounding variables and complicate the interpretation of study outcomes.
  • Autoimmune Disorders: Participants with autoimmune disorders affecting musculoskeletal function, as these conditions may influence the participant's response to interventions and introduce variability in study outcomes.
  • Referred or Radiating Visceral Pains: Individuals experiencing referred or radiating visceral pains, as these symptoms may indicate underlying pathologies requiring specific treatment and may confound the assessment of APT and NSLBP.
  • Gait Abnormalities and Neurological Disorders: Participants with gait abnormalities or neurological disorders affecting musculoskeletal function, as these conditions may influence the participant's ability to perform exercises and interventions and confound study outcomes.
  • Congenital and Developmental Disorders: Individuals with congenital or developmental disorders affecting musculoskeletal function, as these conditions may introduce variability in study outcomes and complicate the interpretation of results.
  • Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with certain physiotherapy modalities and the need for specialized considerations in this population.
  • Contraindications: Participants with contraindications to specific physiotherapy modalities included in the study protocol (e.g., contraindications to electrotherapy) will be excluded to ensure participant safety.
  • Inability to Attend Sessions: Participants who are unable to attend scheduled physiotherapy sessions due to logistical constraints (e.g., transportation issues, scheduling conflicts) will be excluded.
  • Cognitive Impairment: Participants with significant cognitive impairment or communication difficulties that may impede their ability to understand and follow study instructions will be excluded.
  • Participation in Other Research: Participants who are currently participating in other research studies involving treatment interventions for MPS and/or radiculopathy will be excluded to avoid potential confounding effects on outcomes and treatment adherence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Orthopedic & General Hospital

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

RECRUITING

Related Publications (13)

  • Tan BT. A correlation study of the relationship between flat foot with anterior pelvic tilt and sacroiliac joints dysfunction among undergraduate students: UTAR; 2022.

    BACKGROUND
  • Kahere M, Hlongwa M, Ginindza TG. A Scoping Review on the Epidemiology of Chronic Low Back Pain among Adults in Sub-Saharan Africa. Int J Environ Res Public Health. 2022 Mar 3;19(5):2964. doi: 10.3390/ijerph19052964.

    PMID: 35270657BACKGROUND
  • Algarni FS. Comparison of Abdominal and Hip Abductor Activation Between Chronic Low Back Pain and Asymptomatic Individuals During Walking. Masters Abstracts International; 2010.

    BACKGROUND
  • Mavajian M, Fakhari Z, Naghdi S, Bagheri H, Jalaie S. A pilot study on the short-term effects of myofascial release and core stability exercises on balance in chronic low back pain. Auditory and Vestibular Research. 2020.

    BACKGROUND
  • Shariat A, Anastasio AT, Soheili S, Rostad M. Home-based fundamental approach to alleviate low back pain using myofascial release, stretching, and spinal musculature strengthening during the COVID-19 pandemic. Work. 2020;67(1):11-19. doi: 10.3233/WOR-203248.

    PMID: 32955470BACKGROUND
  • Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.

    PMID: 32669487BACKGROUND
  • Weng LM, Zheng YL, Peng MS, Chang TT, Wu B, Wang XQ. A Bibliometric Analysis of Nonspecific Low Back Pain Research. Pain Res Manag. 2020 Mar 9;2020:5396734. doi: 10.1155/2020/5396734. eCollection 2020.

    PMID: 32215136BACKGROUND
  • Morris P, Ali K, Merritt M, Pelletier J, Macedo LG. A systematic review of the role of inflammatory biomarkers in acute, subacute and chronic non-specific low back pain. BMC Musculoskelet Disord. 2020 Mar 3;21(1):142. doi: 10.1186/s12891-020-3154-3.

    PMID: 32126991BACKGROUND
  • Kahere M, Ginindza T. The burden of non-specific chronic low back pain among adults in KwaZulu-Natal, South Africa: a protocol for a mixed-methods study. BMJ Open. 2020 Sep 1;10(9):e039554. doi: 10.1136/bmjopen-2020-039554.

    PMID: 32873683BACKGROUND
  • Bramah C, Mendiguchia J, Dos'Santos T, Morin JB. Exploring the Role of Sprint Biomechanics in Hamstring Strain Injuries: A Current Opinion on Existing Concepts and Evidence. Sports Med. 2024 Apr;54(4):783-793. doi: 10.1007/s40279-023-01925-x. Epub 2023 Sep 19.

    PMID: 37725240BACKGROUND
  • Nagy P. The Biomechanical Demands of Ballet: Implications for Performance Profiling and Injury Aetiology: Edge Hill University; 2021

    BACKGROUND
  • Shojaei I, Salt EG, Bazrgari B. A prospective study of lumbo-pelvic coordination in patients with non-chronic low back pain. J Biomech. 2020 Mar 26;102:109306. doi: 10.1016/j.jbiomech.2019.07.050. Epub 2019 Aug 7.

    PMID: 31427092BACKGROUND
  • Smith BE, Littlewood C, May S. An update of stabilisation exercises for low back pain: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2014 Dec 9;15:416. doi: 10.1186/1471-2474-15-416.

    PMID: 25488399BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Electric Stimulation TherapyMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationComplementary Therapies

Study Officials

  • Mazhar ALI, Phd

    National orhtopedic and general hospital

    STUDY CHAIR

Central Study Contacts

Mahtab AM Patafi, MPhil

CONTACT

Nasir Mehmood, MPhil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants divided into four groups three interventional groups one control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2025

First Posted

August 1, 2025

Study Start

March 20, 2025

Primary Completion

August 10, 2025

Study Completion

October 15, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Due to ethical concerns

Locations