NCT07730463

Brief Summary

Adults with chronic low back pain (CLBP) frequently experience persistent pain, functional disability, and reduced quality of life despite receiving conventional physiotherapy. Dural hypomobility has been proposed as a contributing factor in some individuals with CLBP by limiting normal neural tissue mobility and increasing mechanosensitivity. ELDOA (Étirements Longitudinaux avec Décoaptation Ostéo-Articulaire) is a targeted stretching technique designed to improve spinal decompression, fascial mobility, and neural tissue mobility. However, evidence regarding its effectiveness in patients with CLBP and dural hypomobility remains limited. This randomized controlled trial aims to evaluate the effectiveness of ELDOA stretching combined with standard physiotherapy compared with standard physiotherapy alone in adults with chronic low back pain and dural hypomobility. Participants will receive treatment three times per week for six weeks. Pain intensity, disability, and dural mobility will be assessed using the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), and Slump Test before and after the intervention. The findings may provide evidence regarding the additional benefit of ELDOA as an adjunct to conventional physiotherapy in the management of chronic low back pain associated with dural hypomobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Low Back PainELDOADural Hypomobility

Outcome Measures

Primary Outcomes (2)

  • Disability Measured by the Oswestry Disability Index (ODI)

    Disability related to chronic low back pain will be assessed using the Oswestry Disability Index (ODI). Scores range from 0% to 100%, with higher scores indicating greater disability. The outcome is the change in ODI score from baseline to Week 6.

    Baseline and Week 6

  • Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)

    Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the change in NPRS score from baseline to the end of the 6-week intervention.

    Baseline and Week 6

Secondary Outcomes (1)

  • Dural Mobility Assessed by the Slump Test

    Baseline and Week 6

Study Arms (2)

Standard Physiotherapy + ELDOA Stretching

EXPERIMENTAL

Participants assigned to this arm will receive standard physiotherapy consisting of hot pack application, transcutaneous electrical nerve stimulation (TENS), and manual therapy, together with ELDOA stretching exercises. Treatment will be provided three sessions per week for six weeks.

Procedure: ELDOA StretchingProcedure: Standard Physiotherapy

Standard Physiotherapy

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard physiotherapy consisting of hot pack application, transcutaneous electrical nerve stimulation (TENS), and manual therapy. Treatment will be provided three sessions per week for six weeks.

Procedure: Standard Physiotherapy

Interventions

Participants will perform standardized ELDOA (Étirements Longitudinaux avec Décoaptation Ostéo-Articulaire) stretching exercises targeting the lumbar spine (L1-L2, L2-L3, L3-L4, L4-L5, and L5-S1). Each exercise will be performed for 2 sets of 5 repetitions with a 45-second hold and 15-second rest between sets. Treatment will be supervised by a physiotherapist and administered three times per week for six weeks in addition to standard physiotherapy.

Also known as: Dural Stretching
Standard Physiotherapy + ELDOA Stretching

Standard physiotherapy will consist of superficial heat therapy (hot pack for 10-15 minutes), transcutaneous electrical nerve stimulation (TENS, 80-100 Hz for 10-15 minutes), and manual therapy including myofascial release and soft tissue mobilization of the lumbar paraspinal muscles (5-10 minutes). Treatment will be provided three times per week for six weeks.

Standard PhysiotherapyStandard Physiotherapy + ELDOA Stretching

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 20 to 45 years. Male or female participants. Chronic low back pain persisting for at least 3 months. Positive Slump Test indicating dural hypomobility. Localized mechanical low back pain. Able and willing to participate in the intervention program. Willing to provide written informed consent.

You may not qualify if:

  • History of spinal surgery within the previous 12 months. Vertebral fracture, spinal tumor, spinal infection, or other serious spinal pathology.
  • Spondylolisthesis, ankylosing spondylitis, scoliosis, or kyphosis confirmed clinically or radiographically.
  • Pregnancy. Neurological deficits or progressive neurological disorders. Skin infection or open wounds in the lumbar region that contraindicate treatment.
  • Severe systemic disease that may interfere with participation. Current participation in another clinical trial or structured physiotherapy program for low back pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibadat International hospital Liaqat Rd, opposite Gordon college, Liaquat Bagh, Rawalpindi.

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

  • 1. Aboagye, E., Karlsson, M., Hagberg, J., & Jensen, I. (2015). Cost-effectiveness of early interventions for non-specific low back pain: A randomized controlled study investigating medical yoga, exercise therapy and self-care advice. Journal of Rehabilitation Medicine, 47(2), 167-173. https://doi.org/10.2340/16501977-1910 2. Adams, M. A., & Hutton, W. C. (1982). The mechanics of prolapsed intervertebral disc. International Orthopaedics, 6(4), 249-253. https://doi.org/10.1007/BF00267146 3. Baldassarre, M. E., Di Mauro, A., Pignatelli, M. C., Fanelli, M., Salvatore, S., Di Nardo, G., Chiaro, A., Pensabene, L., & Laforgia, N. (2019). Magnesium alginate in gastro-esophageal reflux: A randomized multicenter cross-over study in infants. International Journal of Environmental Research and Public Health, 17(1), 83. https://doi.org/10.3390/ijerph17010083 4. Childs, J. D., Piva, S. R., & Fritz, J. M. (2005). Responsiveness of the numeric pain rating scale in patients with low back pain. Spine, 30(11), 1331-1334. https://doi.org/10.1097/01.brs.0000164099.92112.29 5. Chou, R., Deyo, R., Friedly, J., Skelly, A., Hashimoto, R., Weimer, M., Fu, R., Dana, T., Kraegel, P., Griffin, J., Grusing, S., & Brodt, E. D. (2017). Nonpharmacologic therapies for low back pain: A systematic review for an American College of Physicians clinical practice guideline. Annals of Internal Medicine, 166(7), 493-505. https://doi.org/10.7326/m16-2459 6. Coppieters, M. W., & Butler, D. S. (2007). Do 'sliders' slide and 'tensioners' tension? An analysis of neurodynamic techniques and considerations regarding their application. Manual Therapy, 13(3), 213-221. https://doi.org/10.1016/j.math.2006.12.008 7. Fairbank, J. C. T., & Pynsent, P. B. (2000). The Oswestry Disability Index. Spine, 25(22), 2940-2953. https://doi.org/10.1097/00007632-200011150-00017 8. Farooq, M., Bashir, M. S., Arif, A., Kashif, M., Manzoor, N., & Abid, F. (2023). Effects of elongation longitudinaux avec decoaption osteo-articulaire

    RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Fawad

    Ibadat International University, Islamabd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single-blind study in which the outcome assessor will be blinded to treatment allocation. Participants and treating physiotherapists cannot be blinded because of the nature of the exercise intervention. Data analysis will be performed using coded group assignments to minimize assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two-arm, parallel-group, randomized controlled trial. Eligible participants with chronic low back pain and dural hypomobility will be randomly allocated in a 1:1 ratio to either the experimental group (standard physiotherapy plus ELDOA stretching) or the control group (standard physiotherapy alone). Both groups will receive treatment three times per week for six weeks. Outcomes will be assessed at baseline and at the end of the intervention period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

January 10, 2026

Primary Completion

May 30, 2026

Study Completion

June 7, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) collected during this study will not be made publicly available because participant confidentiality and privacy will be protected in accordance with institutional ethical guidelines and informed consent procedures. Only aggregated study results will be reported in publications and presentations.

Locations